Trial Outcomes & Findings for Interpretation Training to Reduce Anxiety: Evaluating Technology-based Delivery Models and Methods to Reduce Attrition (NCT NCT03498651)
NCT ID: NCT03498651
Last Updated: 2025-02-19
Results Overview
To measure interpretation bias, participants will read ambiguous scenarios with titles, after which they will see the titles of each scenario, followed by 4 interpretations of the scenario: 1 positive and threat related, 1 negative and threat related, 1 positive and threat unrelated, and 1 negative and threat unrelated. Participants will rate each interpretation based on how similar in meaning it is to the original scenario on a 4-point scale ranging from 1 to 4. The mean of the positive, threat-related ratings index positive interpretation bias. Higher scores represent a more positive interpretation bias.
COMPLETED
PHASE2
1748 participants
Baseline, and after session 3 (2-3 weeks following baseline), session 5 (~2 weeks after session 3), & at 2-month follow-up (~ 2 months after session 5). Measure will be completed immediately following that day's training session.
2025-02-19
Participant Flow
Participant milestones
| Measure |
Received CBM-I and Not Classified as High/Low Risk for Attrition
This group started treatment (and had been Stage 1 randomized to CBM-I) but did not complete Session 1 of CBM-I training plus assessments, so was not classified as high/low risk for attrition and thus not randomized for Stage 2 of SMART design
|
Received CBM-I and Classified Low Attrition
Computer- or phone-based Cognitive Bias Modification - Interpretation training
Cognitive Bias Modification - Interpretation training: Training involves presenting participants with brief scenarios that introduce an ambiguous potential threat. Critically, the ambiguity regarding how the situation is resolved remains until the last word of the scenario, which is presented as a word fragment that the participant must solve, which will typically then assign a benign (rather than threatening) meaning to the scenario.
|
Received CBM-I and Classified High Attrition and no Coach Given
Computer- or phone-based Cognitive Bias Modification - Interpretation training
Cognitive Bias Modification - Interpretation training: Training involves presenting participants with brief scenarios that introduce an ambiguous potential threat. Critically, the ambiguity regarding how the situation is resolved remains until the last word of the scenario, which is presented as a word fragment that the participant must solve, which will typically then assign a benign (rather than threatening) meaning to the scenario.
|
Received CBM-I and Classified High Attrition and Given a Coach
Computer- or phone-based Cognitive Bias Modification - Interpretation training + Coaching
Cognitive Bias Modification - Interpretation training: Training involves presenting participants with brief scenarios that introduce an ambiguous potential threat. Critically, the ambiguity regarding how the situation is resolved remains until the last word of the scenario, which is presented as a word fragment that the participant must solve, which will typically then assign a benign (rather than threatening) meaning to the scenario.
Coaching: Participants identified as high risk for attrition will receive low-intensity coaching, which includes a mix of brief phone calls, texts, and/or emails with a trained member of the study team to help address challenges with adherence to and application of the training.
|
Psychoeducation
Online psychoeducation about anxiety
Online psychoeducation about anxiety: Participants will review webpages that describe information about symptoms and causes of anxiety, including the nature of biased thinking in anxiety.
|
Psychoeducation, Lacking Classification Measures
This group started treatment (and had been Stage 1 randomized to psychoeducation) but did not complete Session 1 of psychoeducation plus assessments, so is not part of the classification measure completer sample
|
Not Randomized to Treatment
Completed consent but didn't complete baseline assessments or reach point of Stage 1 randomization to a treatment arm
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
149
|
288
|
265
|
282
|
242
|
13
|
509
|
|
Overall Study
COMPLETED
|
0
|
140
|
134
|
131
|
154
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
149
|
148
|
131
|
151
|
88
|
13
|
509
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Interpretation Training to Reduce Anxiety: Evaluating Technology-based Delivery Models and Methods to Reduce Attrition
Baseline characteristics by cohort
| Measure |
Received CBM-I and Not Classified as High/Low Risk for Attrition
n=148 Participants
This group started treatment (and had been randomized to CBM-I) but did not complete Session 1 of CBM-I training plus assessments, so was not classified as high/low risk for attrition and thus not randomized for Stage 2 of SMART design
|
Received CBM-I and Classified Low Attrition
n=288 Participants
Computer- or phone-based Cognitive Bias Modification - Interpretation training
Cognitive Bias Modification - Interpretation training: Training involves presenting participants with brief scenarios that introduce an ambiguous potential threat. Critically, the ambiguity regarding how the situation is resolved remains until the last word of the scenario, which is presented as a word fragment that the participant must solve, which will typically then assign a benign (rather than threatening) meaning to the scenario.
|
Received CBM-I and Classified High Attrition and no Coach Given
n=263 Participants
Computer- or phone-based Cognitive Bias Modification - Interpretation training
Cognitive Bias Modification - Interpretation training: Training involves presenting participants with brief scenarios that introduce an ambiguous potential threat. Critically, the ambiguity regarding how the situation is resolved remains until the last word of the scenario, which is presented as a word fragment that the participant must solve, which will typically then assign a benign (rather than threatening) meaning to the scenario.
|
Received CBM-I and Classified High Attrition and Given a Coach
n=281 Participants
Computer- or phone-based Cognitive Bias Modification - Interpretation training + Coaching
Cognitive Bias Modification - Interpretation training: Training involves presenting participants with brief scenarios that introduce an ambiguous potential threat. Critically, the ambiguity regarding how the situation is resolved remains until the last word of the scenario, which is presented as a word fragment that the participant must solve, which will typically then assign a benign (rather than threatening) meaning to the scenario.
Coaching: Participants identified as high risk for attrition will receive low-intensity coaching, which includes a mix of brief phone calls, texts, and/or emails with a trained member of the study team to help address challenges with adherence to and application of the training.
|
Psychoeducation
n=241 Participants
Online psychoeducation about anxiety
Online psychoeducation about anxiety: Participants will review webpages that describe information about symptoms and causes of anxiety, including the nature of biased thinking in anxiety.
|
Psychoeducation, Lacking Classification Measures
n=13 Participants
This group started treatment (and had been Stage 1 randomized to psychoeducation) but did not complete Session 1 of psychoeducation plus assessments, so is not part of the classification measure completer sample
|
Not Randomized to Treatment
Completed consent but didn't complete baseline assessments or reach point of Stage 1 randomization to a treatment arm
|
Removed From Analyses
n=5 Participants
5 participants were removed from analyses as there were concerns with the integrity of their data
|
Total
n=1239 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
34.16 years
STANDARD_DEVIATION 12.09 • n=5 Participants
|
37.2 years
STANDARD_DEVIATION 12.33 • n=7 Participants
|
34.24 years
STANDARD_DEVIATION 11.13 • n=5 Participants
|
34.37 years
STANDARD_DEVIATION 11.9 • n=4 Participants
|
35.09 years
STANDARD_DEVIATION 12.3 • n=21 Participants
|
31.54 years
STANDARD_DEVIATION 10.44 • n=8 Participants
|
—
|
28.50 years
STANDARD_DEVIATION 3.32 • n=24 Participants
|
35.09 years
STANDARD_DEVIATION 11.97 • n=42 Participants
|
|
Sex/Gender, Customized
Female
|
112 Participants
n=5 Participants
|
237 Participants
n=7 Participants
|
217 Participants
n=5 Participants
|
231 Participants
n=4 Participants
|
194 Participants
n=21 Participants
|
11 Participants
n=8 Participants
|
—
|
1 Participants
n=24 Participants
|
1003 Participants
n=42 Participants
|
|
Sex/Gender, Customized
Male
|
33 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
41 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
—
|
3 Participants
n=24 Participants
|
205 Participants
n=42 Participants
|
|
Sex/Gender, Customized
Transgender
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
—
|
0 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
|
Sex/Gender, Customized
Transgender Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
—
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Sex/Gender, Customized
Transgender Male
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
—
|
0 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
|
Sex/Gender, Customized
Other
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
—
|
0 Participants
n=24 Participants
|
16 Participants
n=42 Participants
|
|
Sex/Gender, Customized
Prefer not to answer
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
—
|
1 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Hispanic or Latino
|
22 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
—
|
0 Participants
n=24 Participants
|
164 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not Hispanic or Latino
|
118 Participants
n=5 Participants
|
230 Participants
n=7 Participants
|
224 Participants
n=5 Participants
|
236 Participants
n=4 Participants
|
201 Participants
n=21 Participants
|
10 Participants
n=8 Participants
|
—
|
2 Participants
n=24 Participants
|
1021 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Unknown
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
—
|
1 Participants
n=24 Participants
|
22 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Prefer not to answer
|
5 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
—
|
2 Participants
n=24 Participants
|
32 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian/Alaska Native
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
—
|
0 Participants
n=24 Participants
|
9 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Race · Black/African origin
|
12 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
—
|
0 Participants
n=24 Participants
|
122 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Race · East Asian
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
—
|
1 Participants
n=24 Participants
|
37 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian/Pacific Islander
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
—
|
0 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Race · South Asian
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
—
|
2 Participants
n=24 Participants
|
29 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Race · White/European origin
|
95 Participants
n=5 Participants
|
211 Participants
n=7 Participants
|
185 Participants
n=5 Participants
|
212 Participants
n=4 Participants
|
179 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
—
|
1 Participants
n=24 Participants
|
891 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Race · More than one race
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
—
|
0 Participants
n=24 Participants
|
87 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Race · Other or Unknown
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
—
|
0 Participants
n=24 Participants
|
43 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Race · Prefer not to answer
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
—
|
1 Participants
n=24 Participants
|
17 Participants
n=42 Participants
|
|
Country
United States
|
133 Participants
n=5 Participants
|
256 Participants
n=7 Participants
|
251 Participants
n=5 Participants
|
259 Participants
n=4 Participants
|
214 Participants
n=21 Participants
|
12 Participants
n=8 Participants
|
—
|
2 Participants
n=24 Participants
|
1127 Participants
n=42 Participants
|
|
Country
Australia
|
4 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
—
|
0 Participants
n=24 Participants
|
52 Participants
n=42 Participants
|
|
Country
United Kingdom
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
—
|
1 Participants
n=24 Participants
|
13 Participants
n=42 Participants
|
|
Country
Canada
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
—
|
0 Participants
n=24 Participants
|
12 Participants
n=42 Participants
|
|
Country
Other
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
—
|
1 Participants
n=24 Participants
|
32 Participants
n=42 Participants
|
|
Country
Prefer not to answer
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
—
|
1 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Baseline, and after session 3 (2-3 weeks following baseline), session 5 (~2 weeks after session 3), & at 2-month follow-up (~ 2 months after session 5). Measure will be completed immediately following that day's training session.Population: A few participants were excluded from analyses during data cleaning due to concerns about integrity of their data, hence the # of analyzed participants is slightly below the enrollment #.
To measure interpretation bias, participants will read ambiguous scenarios with titles, after which they will see the titles of each scenario, followed by 4 interpretations of the scenario: 1 positive and threat related, 1 negative and threat related, 1 positive and threat unrelated, and 1 negative and threat unrelated. Participants will rate each interpretation based on how similar in meaning it is to the original scenario on a 4-point scale ranging from 1 to 4. The mean of the positive, threat-related ratings index positive interpretation bias. Higher scores represent a more positive interpretation bias.
Outcome measures
| Measure |
Psychoeducation, Lacking Classification Measures
n=13 Participants
This group started treatment (and had been Stage 1 randomized to psychoeducation) but did not complete Session 1 of psychoeducation plus assessments, so is not part of the classification measure completer sample
|
Received CBM-I and Not Classified as High/Low Risk for Attrition
n=148 Participants
This group started treatment (and had been randomized to CBM-I) but did not complete Session 1 of CBM-I training plus assessments, so was not classified as high/low risk for attrition and thus not randomized for Stage 2 of SMART design
|
Received CBM-I and Classified Low Attrition
n=288 Participants
Computer- or phone-based Cognitive Bias Modification - Interpretation training
Cognitive Bias Modification - Interpretation training: Training involves presenting participants with brief scenarios that introduce an ambiguous potential threat. Critically, the ambiguity regarding how the situation is resolved remains until the last word of the scenario, which is presented as a word fragment that the participant must solve, which will typically then assign a benign (rather than threatening) meaning to the scenario.
|
Received CBM-I and Classified High Attrition and no Coach Given
n=263 Participants
Computer- or phone-based Cognitive Bias Modification - Interpretation training
Cognitive Bias Modification - Interpretation training: Training involves presenting participants with brief scenarios that introduce an ambiguous potential threat. Critically, the ambiguity regarding how the situation is resolved remains until the last word of the scenario, which is presented as a word fragment that the participant must solve, which will typically then assign a benign (rather than threatening) meaning to the scenario.
|
Received CBM-I and Classified High Attrition and Given a Coach
n=281 Participants
Computer- or phone-based Cognitive Bias Modification - Interpretation training + Coaching
Cognitive Bias Modification - Interpretation training: Training involves presenting participants with brief scenarios that introduce an ambiguous potential threat. Critically, the ambiguity regarding how the situation is resolved remains until the last word of the scenario, which is presented as a word fragment that the participant must solve, which will typically then assign a benign (rather than threatening) meaning to the scenario.
Coaching: Participants identified as high risk for attrition will receive low-intensity coaching, which includes a mix of brief phone calls, texts, and/or emails with a trained member of the study team to help address challenges with adherence to and application of the training.
|
Psychoeducation
n=241 Participants
Online psychoeducation about anxiety
Online psychoeducation about anxiety: Participants will review webpages that describe information about symptoms and causes of anxiety, including the nature of biased thinking in anxiety.
|
|---|---|---|---|---|---|---|
|
Change in Recognition Ratings (Positive Interpretation Bias)
Baseline assessment
|
2.40 units on a scale
Standard Deviation 0.60
|
2.40 units on a scale
Standard Deviation 0.47
|
2.29 units on a scale
Standard Deviation 0.53
|
2.29 units on a scale
Standard Deviation 0.54
|
2.30 units on a scale
Standard Deviation 0.53
|
2.33 units on a scale
Standard Deviation 0.54
|
|
Change in Recognition Ratings (Positive Interpretation Bias)
Session 3 assessment
|
—
|
—
|
2.89 units on a scale
Standard Deviation 0.44
|
2.84 units on a scale
Standard Deviation 0.48
|
2.92 units on a scale
Standard Deviation 0.49
|
2.39 units on a scale
Standard Deviation 0.57
|
|
Change in Recognition Ratings (Positive Interpretation Bias)
Session 5 assessment
|
—
|
—
|
2.83 units on a scale
Standard Deviation 0.52
|
2.92 units on a scale
Standard Deviation 0.44
|
2.86 units on a scale
Standard Deviation 0.50
|
2.42 units on a scale
Standard Deviation 0.55
|
|
Change in Recognition Ratings (Positive Interpretation Bias)
Follow-up assessment
|
—
|
—
|
2.71 units on a scale
Standard Deviation 0.47
|
2.80 units on a scale
Standard Deviation 0.46
|
2.75 units on a scale
Standard Deviation 0.54
|
2.48 units on a scale
Standard Deviation 0.53
|
PRIMARY outcome
Timeframe: Baseline, and after session 3 (2-3 weeks following baseline), session 5 (~2 weeks after session 3), & at 2-month follow-up (~ 2 months after session 5). Measure will be completed immediately following that day's training session.Population: A few participants were excluded from analyses during data cleaning due to concerns about integrity of their data, hence the # of analyzed participants is slightly below the enrollment #.
To measure interpretation bias, participants will read ambiguous scenarios with titles, after which they will see the titles of each scenario, followed by 4 interpretations of the scenario: 1 positive and threat related, 1 negative and threat related, 1 positive and threat unrelated, and 1 negative and threat unrelated. Participants will rate each interpretation based on how similar in meaning it is to the original scenario on a 4-point scale ranging from 1 to 4. The mean of the negative, threat-related ratings index negative interpretation bias. Higher scores represent a more negative interpretation bias.
Outcome measures
| Measure |
Psychoeducation, Lacking Classification Measures
n=13 Participants
This group started treatment (and had been Stage 1 randomized to psychoeducation) but did not complete Session 1 of psychoeducation plus assessments, so is not part of the classification measure completer sample
|
Received CBM-I and Not Classified as High/Low Risk for Attrition
n=148 Participants
This group started treatment (and had been randomized to CBM-I) but did not complete Session 1 of CBM-I training plus assessments, so was not classified as high/low risk for attrition and thus not randomized for Stage 2 of SMART design
|
Received CBM-I and Classified Low Attrition
n=288 Participants
Computer- or phone-based Cognitive Bias Modification - Interpretation training
Cognitive Bias Modification - Interpretation training: Training involves presenting participants with brief scenarios that introduce an ambiguous potential threat. Critically, the ambiguity regarding how the situation is resolved remains until the last word of the scenario, which is presented as a word fragment that the participant must solve, which will typically then assign a benign (rather than threatening) meaning to the scenario.
|
Received CBM-I and Classified High Attrition and no Coach Given
n=263 Participants
Computer- or phone-based Cognitive Bias Modification - Interpretation training
Cognitive Bias Modification - Interpretation training: Training involves presenting participants with brief scenarios that introduce an ambiguous potential threat. Critically, the ambiguity regarding how the situation is resolved remains until the last word of the scenario, which is presented as a word fragment that the participant must solve, which will typically then assign a benign (rather than threatening) meaning to the scenario.
|
Received CBM-I and Classified High Attrition and Given a Coach
n=281 Participants
Computer- or phone-based Cognitive Bias Modification - Interpretation training + Coaching
Cognitive Bias Modification - Interpretation training: Training involves presenting participants with brief scenarios that introduce an ambiguous potential threat. Critically, the ambiguity regarding how the situation is resolved remains until the last word of the scenario, which is presented as a word fragment that the participant must solve, which will typically then assign a benign (rather than threatening) meaning to the scenario.
Coaching: Participants identified as high risk for attrition will receive low-intensity coaching, which includes a mix of brief phone calls, texts, and/or emails with a trained member of the study team to help address challenges with adherence to and application of the training.
|
Psychoeducation
n=241 Participants
Online psychoeducation about anxiety
Online psychoeducation about anxiety: Participants will review webpages that describe information about symptoms and causes of anxiety, including the nature of biased thinking in anxiety.
|
|---|---|---|---|---|---|---|
|
Change in Recognition Ratings (Negative Interpretation Bias)
Baseline assessment
|
2.70 units on a scale
Standard Deviation 0.60
|
2.78 units on a scale
Standard Deviation 0.53
|
2.90 units on a scale
Standard Deviation 0.54
|
2.96 units on a scale
Standard Deviation 0.51
|
2.94 units on a scale
Standard Deviation 0.55
|
2.89 units on a scale
Standard Deviation 0.50
|
|
Change in Recognition Ratings (Negative Interpretation Bias)
Session 3 assessment
|
—
|
—
|
2.56 units on a scale
Standard Deviation 0.56
|
2.49 units on a scale
Standard Deviation 0.55
|
2.46 units on a scale
Standard Deviation 0.58
|
2.87 units on a scale
Standard Deviation 0.55
|
|
Change in Recognition Ratings (Negative Interpretation Bias)
Session 5 assessment
|
—
|
—
|
2.58 units on a scale
Standard Deviation 0.55
|
2.53 units on a scale
Standard Deviation 0.56
|
2.56 units on a scale
Standard Deviation 0.52
|
2.74 units on a scale
Standard Deviation 0.59
|
|
Change in Recognition Ratings (Negative Interpretation Bias)
Follow-up assessment
|
—
|
—
|
2.55 units on a scale
Standard Deviation 0.55
|
2.48 units on a scale
Standard Deviation 0.56
|
2.43 units on a scale
Standard Deviation 0.58
|
2.68 units on a scale
Standard Deviation 0.58
|
PRIMARY outcome
Timeframe: Baseline, and after session 3 (2-3 weeks following baseline), session 5 (~2 weeks after session 3), & at 2-month follow-up (~ 2 months after session 5). Measure will be completed immediately following that day's training session.Population: A few participants were excluded from analyses during data cleaning due to concerns about integrity of their data, hence the # of analyzed participants is slightly below the enrollment #.
To assess interpretation change, participants are presented with ambiguous events and then asked to rate three alternative explanations for why the event might have occurred on a 5-point scale ranging from 0 to 4. One option is always negative and threat related, whereas the other options are mixed in valence but threat unrelated. We computed the mean of the threat-unrelated ratings as an index of benign interpretation bias. Higher scores represent a more benign interpretation bias.
Outcome measures
| Measure |
Psychoeducation, Lacking Classification Measures
n=13 Participants
This group started treatment (and had been Stage 1 randomized to psychoeducation) but did not complete Session 1 of psychoeducation plus assessments, so is not part of the classification measure completer sample
|
Received CBM-I and Not Classified as High/Low Risk for Attrition
n=148 Participants
This group started treatment (and had been randomized to CBM-I) but did not complete Session 1 of CBM-I training plus assessments, so was not classified as high/low risk for attrition and thus not randomized for Stage 2 of SMART design
|
Received CBM-I and Classified Low Attrition
n=288 Participants
Computer- or phone-based Cognitive Bias Modification - Interpretation training
Cognitive Bias Modification - Interpretation training: Training involves presenting participants with brief scenarios that introduce an ambiguous potential threat. Critically, the ambiguity regarding how the situation is resolved remains until the last word of the scenario, which is presented as a word fragment that the participant must solve, which will typically then assign a benign (rather than threatening) meaning to the scenario.
|
Received CBM-I and Classified High Attrition and no Coach Given
n=263 Participants
Computer- or phone-based Cognitive Bias Modification - Interpretation training
Cognitive Bias Modification - Interpretation training: Training involves presenting participants with brief scenarios that introduce an ambiguous potential threat. Critically, the ambiguity regarding how the situation is resolved remains until the last word of the scenario, which is presented as a word fragment that the participant must solve, which will typically then assign a benign (rather than threatening) meaning to the scenario.
|
Received CBM-I and Classified High Attrition and Given a Coach
n=281 Participants
Computer- or phone-based Cognitive Bias Modification - Interpretation training + Coaching
Cognitive Bias Modification - Interpretation training: Training involves presenting participants with brief scenarios that introduce an ambiguous potential threat. Critically, the ambiguity regarding how the situation is resolved remains until the last word of the scenario, which is presented as a word fragment that the participant must solve, which will typically then assign a benign (rather than threatening) meaning to the scenario.
Coaching: Participants identified as high risk for attrition will receive low-intensity coaching, which includes a mix of brief phone calls, texts, and/or emails with a trained member of the study team to help address challenges with adherence to and application of the training.
|
Psychoeducation
n=241 Participants
Online psychoeducation about anxiety
Online psychoeducation about anxiety: Participants will review webpages that describe information about symptoms and causes of anxiety, including the nature of biased thinking in anxiety.
|
|---|---|---|---|---|---|---|
|
Change in Brief Bodily Sensations Interpretations Questionnaire (Benign Interpretation Bias)
Baseline assessment
|
2.23 units on a scale
Standard Deviation 0.38
|
2.04 units on a scale
Standard Deviation 0.55
|
2.00 units on a scale
Standard Deviation 0.53
|
2.13 units on a scale
Standard Deviation 0.49
|
2.05 units on a scale
Standard Deviation 0.52
|
2.07 units on a scale
Standard Deviation 0.55
|
|
Change in Brief Bodily Sensations Interpretations Questionnaire (Benign Interpretation Bias)
Session 3 assessment
|
—
|
—
|
2.25 units on a scale
Standard Deviation 0.55
|
2.38 units on a scale
Standard Deviation 0.53
|
2.36 units on a scale
Standard Deviation 0.52
|
2.20 units on a scale
Standard Deviation 0.51
|
|
Change in Brief Bodily Sensations Interpretations Questionnaire (Benign Interpretation Bias)
Session 5 assessment
|
—
|
—
|
2.34 units on a scale
Standard Deviation 0.62
|
2.51 units on a scale
Standard Deviation 0.52
|
2.45 units on a scale
Standard Deviation 0.53
|
2.19 units on a scale
Standard Deviation 0.58
|
|
Change in Brief Bodily Sensations Interpretations Questionnaire (Benign Interpretation Bias)
Follow-up assessment
|
—
|
—
|
2.31 units on a scale
Standard Deviation 0.56
|
2.35 units on a scale
Standard Deviation 0.58
|
2.36 units on a scale
Standard Deviation 0.55
|
2.23 units on a scale
Standard Deviation 0.61
|
PRIMARY outcome
Timeframe: Baseline, and after session 3 (2-3 weeks following baseline), session 5 (~2 weeks after session 3), & at 2-month follow-up (~ 2 months after session 5). Measure will be completed immediately following that day's training session.Population: A few participants were excluded from analyses during data cleaning due to concerns about integrity of their data, hence the # of analyzed participants is slightly below the enrollment #.
To assess interpretation change, participants are presented with ambiguous events and then asked to rate three alternative explanations for why the event might have occurred on a 5-point scale ranging from 0 to 4. One option is always negative and threat related, whereas the other options are mixed in valence but threat unrelated. We computed the mean of the negative, threat-related ratings as an index of negative interpretation bias. Higher scores represent a more negative interpretation bias.
Outcome measures
| Measure |
Psychoeducation, Lacking Classification Measures
n=13 Participants
This group started treatment (and had been Stage 1 randomized to psychoeducation) but did not complete Session 1 of psychoeducation plus assessments, so is not part of the classification measure completer sample
|
Received CBM-I and Not Classified as High/Low Risk for Attrition
n=148 Participants
This group started treatment (and had been randomized to CBM-I) but did not complete Session 1 of CBM-I training plus assessments, so was not classified as high/low risk for attrition and thus not randomized for Stage 2 of SMART design
|
Received CBM-I and Classified Low Attrition
n=288 Participants
Computer- or phone-based Cognitive Bias Modification - Interpretation training
Cognitive Bias Modification - Interpretation training: Training involves presenting participants with brief scenarios that introduce an ambiguous potential threat. Critically, the ambiguity regarding how the situation is resolved remains until the last word of the scenario, which is presented as a word fragment that the participant must solve, which will typically then assign a benign (rather than threatening) meaning to the scenario.
|
Received CBM-I and Classified High Attrition and no Coach Given
n=263 Participants
Computer- or phone-based Cognitive Bias Modification - Interpretation training
Cognitive Bias Modification - Interpretation training: Training involves presenting participants with brief scenarios that introduce an ambiguous potential threat. Critically, the ambiguity regarding how the situation is resolved remains until the last word of the scenario, which is presented as a word fragment that the participant must solve, which will typically then assign a benign (rather than threatening) meaning to the scenario.
|
Received CBM-I and Classified High Attrition and Given a Coach
n=281 Participants
Computer- or phone-based Cognitive Bias Modification - Interpretation training + Coaching
Cognitive Bias Modification - Interpretation training: Training involves presenting participants with brief scenarios that introduce an ambiguous potential threat. Critically, the ambiguity regarding how the situation is resolved remains until the last word of the scenario, which is presented as a word fragment that the participant must solve, which will typically then assign a benign (rather than threatening) meaning to the scenario.
Coaching: Participants identified as high risk for attrition will receive low-intensity coaching, which includes a mix of brief phone calls, texts, and/or emails with a trained member of the study team to help address challenges with adherence to and application of the training.
|
Psychoeducation
n=241 Participants
Online psychoeducation about anxiety
Online psychoeducation about anxiety: Participants will review webpages that describe information about symptoms and causes of anxiety, including the nature of biased thinking in anxiety.
|
|---|---|---|---|---|---|---|
|
Change in Brief Bodily Sensations Interpretations Questionnaire (Negative Interpretation Bias)
Baseline assessment
|
1.35 units on a scale
Standard Deviation 0.94
|
1.42 units on a scale
Standard Deviation 0.83
|
1.61 units on a scale
Standard Deviation 0.86
|
1.52 units on a scale
Standard Deviation 0.81
|
1.58 units on a scale
Standard Deviation 0.82
|
1.61 units on a scale
Standard Deviation 0.81
|
|
Change in Brief Bodily Sensations Interpretations Questionnaire (Negative Interpretation Bias)
Session 3 assessment
|
—
|
—
|
0.93 units on a scale
Standard Deviation 0.80
|
0.85 units on a scale
Standard Deviation 0.66
|
0.85 units on a scale
Standard Deviation 0.71
|
1.36 units on a scale
Standard Deviation 0.81
|
|
Change in Brief Bodily Sensations Interpretations Questionnaire (Negative Interpretation Bias)
Session 5 assessment
|
—
|
—
|
0.81 units on a scale
Standard Deviation 0.68
|
0.77 units on a scale
Standard Deviation 0.68
|
0.83 units on a scale
Standard Deviation 0.70
|
1.24 units on a scale
Standard Deviation 0.78
|
|
Change in Brief Bodily Sensations Interpretations Questionnaire (Negative Interpretation Bias)
Follow-up assessment
|
—
|
—
|
0.78 units on a scale
Standard Deviation 0.62
|
0.79 units on a scale
Standard Deviation 0.62
|
0.69 units on a scale
Standard Deviation 0.57
|
1.16 units on a scale
Standard Deviation 0.77
|
PRIMARY outcome
Timeframe: Baseline, and after sessions 1,2, 3, 4, 5 (sessions will be spaced ~1 week apart) & at 2-month follow-up (~2 months after session 5). Session 1 occurs ~0-7 days after baseline. Measure will be completed immediately following that day's training session.Population: A few participants were excluded from analyses during data cleaning due to concerns about integrity of their data, hence the # of analyzed participants is slightly below the enrollment #.
This 5-item measure of anxiety symptom severity and impairment has good psychometric properties, shows treatment sensitivity, and is valid in community and clinical samples. Item range = 0 to 4 (5-point scale). Total scale range = 0-20, with a higher score indicating more severe anxiety. Average item scores are reported below.
Outcome measures
| Measure |
Psychoeducation, Lacking Classification Measures
n=13 Participants
This group started treatment (and had been Stage 1 randomized to psychoeducation) but did not complete Session 1 of psychoeducation plus assessments, so is not part of the classification measure completer sample
|
Received CBM-I and Not Classified as High/Low Risk for Attrition
n=148 Participants
This group started treatment (and had been randomized to CBM-I) but did not complete Session 1 of CBM-I training plus assessments, so was not classified as high/low risk for attrition and thus not randomized for Stage 2 of SMART design
|
Received CBM-I and Classified Low Attrition
n=288 Participants
Computer- or phone-based Cognitive Bias Modification - Interpretation training
Cognitive Bias Modification - Interpretation training: Training involves presenting participants with brief scenarios that introduce an ambiguous potential threat. Critically, the ambiguity regarding how the situation is resolved remains until the last word of the scenario, which is presented as a word fragment that the participant must solve, which will typically then assign a benign (rather than threatening) meaning to the scenario.
|
Received CBM-I and Classified High Attrition and no Coach Given
n=263 Participants
Computer- or phone-based Cognitive Bias Modification - Interpretation training
Cognitive Bias Modification - Interpretation training: Training involves presenting participants with brief scenarios that introduce an ambiguous potential threat. Critically, the ambiguity regarding how the situation is resolved remains until the last word of the scenario, which is presented as a word fragment that the participant must solve, which will typically then assign a benign (rather than threatening) meaning to the scenario.
|
Received CBM-I and Classified High Attrition and Given a Coach
n=281 Participants
Computer- or phone-based Cognitive Bias Modification - Interpretation training + Coaching
Cognitive Bias Modification - Interpretation training: Training involves presenting participants with brief scenarios that introduce an ambiguous potential threat. Critically, the ambiguity regarding how the situation is resolved remains until the last word of the scenario, which is presented as a word fragment that the participant must solve, which will typically then assign a benign (rather than threatening) meaning to the scenario.
Coaching: Participants identified as high risk for attrition will receive low-intensity coaching, which includes a mix of brief phone calls, texts, and/or emails with a trained member of the study team to help address challenges with adherence to and application of the training.
|
Psychoeducation
n=241 Participants
Online psychoeducation about anxiety
Online psychoeducation about anxiety: Participants will review webpages that describe information about symptoms and causes of anxiety, including the nature of biased thinking in anxiety.
|
|---|---|---|---|---|---|---|
|
Change in Overall Anxiety Severity and Impairment Scale
Baseline assessment
|
2.62 units on a scale
Standard Deviation 0.79
|
2.28 units on a scale
Standard Deviation 0.75
|
2.32 units on a scale
Standard Deviation 0.71
|
2.31 units on a scale
Standard Deviation 0.67
|
2.34 units on a scale
Standard Deviation 0.67
|
2.31 units on a scale
Standard Deviation 0.68
|
|
Change in Overall Anxiety Severity and Impairment Scale
Session 1 assessment
|
—
|
2.00 units on a scale
Standard Deviation NA
1 Participant
|
2.22 units on a scale
Standard Deviation 0.73
|
2.15 units on a scale
Standard Deviation 0.75
|
2.21 units on a scale
Standard Deviation 0.72
|
2.24 units on a scale
Standard Deviation 0.73
|
|
Change in Overall Anxiety Severity and Impairment Scale
Session 2 assessment
|
—
|
—
|
1.75 units on a scale
Standard Deviation 0.74
|
1.71 units on a scale
Standard Deviation 0.74
|
1.79 units on a scale
Standard Deviation 0.75
|
1.92 units on a scale
Standard Deviation 0.75
|
|
Change in Overall Anxiety Severity and Impairment Scale
Session 3 assessment
|
—
|
—
|
1.80 units on a scale
Standard Deviation 0.80
|
1.72 units on a scale
Standard Deviation 0.79
|
1.84 units on a scale
Standard Deviation 0.74
|
2.00 units on a scale
Standard Deviation 0.78
|
|
Change in Overall Anxiety Severity and Impairment Scale
Session 4 assessment
|
—
|
—
|
1.63 units on a scale
Standard Deviation 0.84
|
1.48 units on a scale
Standard Deviation 0.80
|
1.53 units on a scale
Standard Deviation 0.78
|
1.85 units on a scale
Standard Deviation 0.90
|
|
Change in Overall Anxiety Severity and Impairment Scale
Session 5 assessment
|
—
|
—
|
1.58 units on a scale
Standard Deviation 0.78
|
1.50 units on a scale
Standard Deviation 0.78
|
1.62 units on a scale
Standard Deviation 0.80
|
1.77 units on a scale
Standard Deviation 0.85
|
|
Change in Overall Anxiety Severity and Impairment Scale
Follow-up assessment
|
—
|
—
|
1.59 units on a scale
Standard Deviation 0.79
|
1.56 units on a scale
Standard Deviation 0.87
|
1.60 units on a scale
Standard Deviation 0.79
|
1.68 units on a scale
Standard Deviation 0.81
|
PRIMARY outcome
Timeframe: Baseline, and after session 3 (2-3 weeks following baseline), session 5 (~2 weeks after session 3), & at 2-month follow-up (~ 2 months after session 5). Measure will be completed immediately following that day's training session.Population: A few participants were excluded from analyses during data cleaning due to concerns about integrity of their data, hence the # of analyzed participants is slightly below the enrollment #.
This 7-item measure of anxiety symptoms has good psychometric properties, shows treatment sensitivity, and is valid in community and clinical samples. Item range = 0 to 3 (4-point scale). Total DASS-21 anxiety subscale range = 0-21 (multiplied by 2 for DASS-42 = 0-42), with a higher score indicating more severe anxiety symptoms. Average item scores are reported below.
Outcome measures
| Measure |
Psychoeducation, Lacking Classification Measures
n=13 Participants
This group started treatment (and had been Stage 1 randomized to psychoeducation) but did not complete Session 1 of psychoeducation plus assessments, so is not part of the classification measure completer sample
|
Received CBM-I and Not Classified as High/Low Risk for Attrition
n=148 Participants
This group started treatment (and had been randomized to CBM-I) but did not complete Session 1 of CBM-I training plus assessments, so was not classified as high/low risk for attrition and thus not randomized for Stage 2 of SMART design
|
Received CBM-I and Classified Low Attrition
n=288 Participants
Computer- or phone-based Cognitive Bias Modification - Interpretation training
Cognitive Bias Modification - Interpretation training: Training involves presenting participants with brief scenarios that introduce an ambiguous potential threat. Critically, the ambiguity regarding how the situation is resolved remains until the last word of the scenario, which is presented as a word fragment that the participant must solve, which will typically then assign a benign (rather than threatening) meaning to the scenario.
|
Received CBM-I and Classified High Attrition and no Coach Given
n=263 Participants
Computer- or phone-based Cognitive Bias Modification - Interpretation training
Cognitive Bias Modification - Interpretation training: Training involves presenting participants with brief scenarios that introduce an ambiguous potential threat. Critically, the ambiguity regarding how the situation is resolved remains until the last word of the scenario, which is presented as a word fragment that the participant must solve, which will typically then assign a benign (rather than threatening) meaning to the scenario.
|
Received CBM-I and Classified High Attrition and Given a Coach
n=281 Participants
Computer- or phone-based Cognitive Bias Modification - Interpretation training + Coaching
Cognitive Bias Modification - Interpretation training: Training involves presenting participants with brief scenarios that introduce an ambiguous potential threat. Critically, the ambiguity regarding how the situation is resolved remains until the last word of the scenario, which is presented as a word fragment that the participant must solve, which will typically then assign a benign (rather than threatening) meaning to the scenario.
Coaching: Participants identified as high risk for attrition will receive low-intensity coaching, which includes a mix of brief phone calls, texts, and/or emails with a trained member of the study team to help address challenges with adherence to and application of the training.
|
Psychoeducation
n=241 Participants
Online psychoeducation about anxiety
Online psychoeducation about anxiety: Participants will review webpages that describe information about symptoms and causes of anxiety, including the nature of biased thinking in anxiety.
|
|---|---|---|---|---|---|---|
|
Change in Depression, Anxiety, Stress Scales-Short Form: Anxiety Subscale
Baseline assessment
|
1.71 units on a scale
Standard Deviation 0.64
|
1.61 units on a scale
Standard Deviation 0.55
|
1.58 units on a scale
Standard Deviation 0.53
|
1.65 units on a scale
Standard Deviation 0.54
|
1.65 units on a scale
Standard Deviation 0.53
|
1.65 units on a scale
Standard Deviation 0.52
|
|
Change in Depression, Anxiety, Stress Scales-Short Form: Anxiety Subscale
Session 3 assessment
|
—
|
—
|
1.01 units on a scale
Standard Deviation 0.61
|
0.98 units on a scale
Standard Deviation 0.62
|
1.07 units on a scale
Standard Deviation 0.62
|
1.19 units on a scale
Standard Deviation 0.64
|
|
Change in Depression, Anxiety, Stress Scales-Short Form: Anxiety Subscale
Session 5 assessment
|
—
|
—
|
0.89 units on a scale
Standard Deviation 0.58
|
0.83 units on a scale
Standard Deviation 0.57
|
0.89 units on a scale
Standard Deviation 0.62
|
1.03 units on a scale
Standard Deviation 0.67
|
|
Change in Depression, Anxiety, Stress Scales-Short Form: Anxiety Subscale
Follow-up assessment
|
—
|
—
|
0.82 units on a scale
Standard Deviation 0.57
|
0.80 units on a scale
Standard Deviation 0.63
|
0.80 units on a scale
Standard Deviation 0.64
|
0.97 units on a scale
Standard Deviation 0.62
|
SECONDARY outcome
Timeframe: Baseline, and after session 3 (2-3 weeks following baseline), session 5 (~2 weeks after session 3), & at 2-month follow-up (~ 2 months after session 5). Measure will be completed immediately following that day's training session.Population: Some weeks have less participants reported than overall number analyzed because of attrition - participants did not fill out the survey and thus we do not have data to report on all participants across all weeks.
The Patient Health Questionnaire 2 (PHQ-2) inquires about the frequency of depressed mood and anhedonia. A score of 3 or higher on the Patient Health Questionnaire-2 (PHQ-2) is considered an indication of major depressive disorder. The PHQ-2 is a two-question screening tool that asks how often a person has experienced depressed mood or anhedonia over the past two weeks. The score range is 0-6, with higher scores indicating more frequent symptoms, and response options 0-3 for each question where 0: Not at all, 1: Several days, 2: More than half the days, 3: Nearly every day.
Outcome measures
| Measure |
Psychoeducation, Lacking Classification Measures
n=13 Participants
This group started treatment (and had been Stage 1 randomized to psychoeducation) but did not complete Session 1 of psychoeducation plus assessments, so is not part of the classification measure completer sample
|
Received CBM-I and Not Classified as High/Low Risk for Attrition
n=148 Participants
This group started treatment (and had been randomized to CBM-I) but did not complete Session 1 of CBM-I training plus assessments, so was not classified as high/low risk for attrition and thus not randomized for Stage 2 of SMART design
|
Received CBM-I and Classified Low Attrition
n=288 Participants
Computer- or phone-based Cognitive Bias Modification - Interpretation training
Cognitive Bias Modification - Interpretation training: Training involves presenting participants with brief scenarios that introduce an ambiguous potential threat. Critically, the ambiguity regarding how the situation is resolved remains until the last word of the scenario, which is presented as a word fragment that the participant must solve, which will typically then assign a benign (rather than threatening) meaning to the scenario.
|
Received CBM-I and Classified High Attrition and no Coach Given
n=263 Participants
Computer- or phone-based Cognitive Bias Modification - Interpretation training
Cognitive Bias Modification - Interpretation training: Training involves presenting participants with brief scenarios that introduce an ambiguous potential threat. Critically, the ambiguity regarding how the situation is resolved remains until the last word of the scenario, which is presented as a word fragment that the participant must solve, which will typically then assign a benign (rather than threatening) meaning to the scenario.
|
Received CBM-I and Classified High Attrition and Given a Coach
n=281 Participants
Computer- or phone-based Cognitive Bias Modification - Interpretation training + Coaching
Cognitive Bias Modification - Interpretation training: Training involves presenting participants with brief scenarios that introduce an ambiguous potential threat. Critically, the ambiguity regarding how the situation is resolved remains until the last word of the scenario, which is presented as a word fragment that the participant must solve, which will typically then assign a benign (rather than threatening) meaning to the scenario.
Coaching: Participants identified as high risk for attrition will receive low-intensity coaching, which includes a mix of brief phone calls, texts, and/or emails with a trained member of the study team to help address challenges with adherence to and application of the training.
|
Psychoeducation
n=241 Participants
Online psychoeducation about anxiety
Online psychoeducation about anxiety: Participants will review webpages that describe information about symptoms and causes of anxiety, including the nature of biased thinking in anxiety.
|
|---|---|---|---|---|---|---|
|
Change in Depression Comorbid Symptoms
Baseline
|
2.92 score on a scale
Standard Deviation 0.95
|
2.77 score on a scale
Standard Deviation 0.86
|
2.76 score on a scale
Standard Deviation 0.90
|
2.68 score on a scale
Standard Deviation 0.93
|
2.77 score on a scale
Standard Deviation 0.91
|
2.78 score on a scale
Standard Deviation 0.89
|
|
Change in Depression Comorbid Symptoms
Session 3
|
—
|
—
|
2.35 score on a scale
Standard Deviation 0.92
|
2.22 score on a scale
Standard Deviation 0.86
|
2.32 score on a scale
Standard Deviation 0.90
|
2.49 score on a scale
Standard Deviation 0.96
|
|
Change in Depression Comorbid Symptoms
Session 5
|
—
|
—
|
2.15 score on a scale
Standard Deviation 0.92
|
2.12 score on a scale
Standard Deviation 0.90
|
2.13 score on a scale
Standard Deviation 0.90
|
2.36 score on a scale
Standard Deviation 0.97
|
|
Change in Depression Comorbid Symptoms
2-month Follow-up
|
—
|
—
|
2.15 score on a scale
Standard Deviation 0.91
|
2.00 score on a scale
Standard Deviation 0.93
|
2.00 score on a scale
Standard Deviation 0.89
|
2.09 score on a scale
Standard Deviation 0.88
|
SECONDARY outcome
Timeframe: Baseline, and after session 3 (2-3 weeks following baseline), session 5 (~2 weeks after session 3), & at 2-month follow-up (~ 2 months after session 5). Measure will be completed immediately following that day's training session.Population: Some weeks have less participants reported than overall number analyzed because of attrition - participants did not fill out the survey and thus we do not have data to report on all participants across all weeks.
The Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) is a 3-item alcohol screen that can help identify persons who are hazardous drinkers or have active alcohol use disorders. The AUDIT has 10 questions and the possible responses to each question are scored 0, 1, 2, 3 or 4, with the exception of questions 9 and 10 which have possible responses of 0, 2 and 4. The range of possible scores is from 0 to 40 where 0 indicates an abstainer who has never had any problems from alcohol. A score of 1 to 7 suggests low-risk consumption according to World Health Organization (WHO) guidelines. Scores from 8 to 14 suggest hazardous or harmful alcohol consumption and a score of 15 or more indicates the likelihood of alcohol dependence (moderate-severe alcohol use disorder).
Outcome measures
| Measure |
Psychoeducation, Lacking Classification Measures
n=13 Participants
This group started treatment (and had been Stage 1 randomized to psychoeducation) but did not complete Session 1 of psychoeducation plus assessments, so is not part of the classification measure completer sample
|
Received CBM-I and Not Classified as High/Low Risk for Attrition
n=148 Participants
This group started treatment (and had been randomized to CBM-I) but did not complete Session 1 of CBM-I training plus assessments, so was not classified as high/low risk for attrition and thus not randomized for Stage 2 of SMART design
|
Received CBM-I and Classified Low Attrition
n=288 Participants
Computer- or phone-based Cognitive Bias Modification - Interpretation training
Cognitive Bias Modification - Interpretation training: Training involves presenting participants with brief scenarios that introduce an ambiguous potential threat. Critically, the ambiguity regarding how the situation is resolved remains until the last word of the scenario, which is presented as a word fragment that the participant must solve, which will typically then assign a benign (rather than threatening) meaning to the scenario.
|
Received CBM-I and Classified High Attrition and no Coach Given
n=263 Participants
Computer- or phone-based Cognitive Bias Modification - Interpretation training
Cognitive Bias Modification - Interpretation training: Training involves presenting participants with brief scenarios that introduce an ambiguous potential threat. Critically, the ambiguity regarding how the situation is resolved remains until the last word of the scenario, which is presented as a word fragment that the participant must solve, which will typically then assign a benign (rather than threatening) meaning to the scenario.
|
Received CBM-I and Classified High Attrition and Given a Coach
n=281 Participants
Computer- or phone-based Cognitive Bias Modification - Interpretation training + Coaching
Cognitive Bias Modification - Interpretation training: Training involves presenting participants with brief scenarios that introduce an ambiguous potential threat. Critically, the ambiguity regarding how the situation is resolved remains until the last word of the scenario, which is presented as a word fragment that the participant must solve, which will typically then assign a benign (rather than threatening) meaning to the scenario.
Coaching: Participants identified as high risk for attrition will receive low-intensity coaching, which includes a mix of brief phone calls, texts, and/or emails with a trained member of the study team to help address challenges with adherence to and application of the training.
|
Psychoeducation
n=241 Participants
Online psychoeducation about anxiety
Online psychoeducation about anxiety: Participants will review webpages that describe information about symptoms and causes of anxiety, including the nature of biased thinking in anxiety.
|
|---|---|---|---|---|---|---|
|
Change in Alcohol Use Comorbid Symptoms
Session 3
|
—
|
—
|
0.88 score on a scale
Standard Deviation 0.89
|
0.92 score on a scale
Standard Deviation 0.83
|
0.80 score on a scale
Standard Deviation 0.73
|
0.84 score on a scale
Standard Deviation 0.85
|
|
Change in Alcohol Use Comorbid Symptoms
2-month Follow-up
|
—
|
—
|
0.78 score on a scale
Standard Deviation 0.80
|
0.80 score on a scale
Standard Deviation 0.70
|
0.59 score on a scale
Standard Deviation 0.62
|
0.71 score on a scale
Standard Deviation 0.80
|
|
Change in Alcohol Use Comorbid Symptoms
Session 5
|
—
|
—
|
0.75 score on a scale
Standard Deviation 0.75
|
0.85 score on a scale
Standard Deviation 0.77
|
0.71 score on a scale
Standard Deviation 0.73
|
0.78 score on a scale
Standard Deviation 0.80
|
|
Change in Alcohol Use Comorbid Symptoms
Baseline
|
0.64 score on a scale
Standard Deviation 0.73
|
0.92 score on a scale
Standard Deviation 0.82
|
0.90 score on a scale
Standard Deviation 0.84
|
0.94 score on a scale
Standard Deviation 0.86
|
0.95 score on a scale
Standard Deviation 0.79
|
0.90 score on a scale
Standard Deviation 0.89
|
SECONDARY outcome
Timeframe: Baseline, and after session 3 (2-3 weeks following baseline), session 5 (~2 weeks after session 3), & at 2-month follow-up (~ 2 months after session 5). Measure will be completed immediately following that day's training session.Population: Some weeks have less participants reported than overall number analyzed because of attrition - participants did not fill out the survey and thus we do not have data to report on all participants across all weeks.
Items 3 and 7 from the Life Orientation Test-Revised (LOT-R) assess generalized optimism versus pessimism. Responses include: 0 = Strongly disagree, 1 = Disagree, 2 = Neutral, 3 = Agree, and 4 = Strongly agree, plus Prefer not to answer. Total aggregate scores range from 0 to 4 by taking the mean of the 2 items. Higher scores indicate lower optimism/higher pessimism. We calculate participants' optimism scores by taking the mean of the two items, and we are reporting these mean optimism scores below. Questions are: If something can go wrong with me, it will. I hardly ever expect things to go my way.
Outcome measures
| Measure |
Psychoeducation, Lacking Classification Measures
n=13 Participants
This group started treatment (and had been Stage 1 randomized to psychoeducation) but did not complete Session 1 of psychoeducation plus assessments, so is not part of the classification measure completer sample
|
Received CBM-I and Not Classified as High/Low Risk for Attrition
n=148 Participants
This group started treatment (and had been randomized to CBM-I) but did not complete Session 1 of CBM-I training plus assessments, so was not classified as high/low risk for attrition and thus not randomized for Stage 2 of SMART design
|
Received CBM-I and Classified Low Attrition
n=288 Participants
Computer- or phone-based Cognitive Bias Modification - Interpretation training
Cognitive Bias Modification - Interpretation training: Training involves presenting participants with brief scenarios that introduce an ambiguous potential threat. Critically, the ambiguity regarding how the situation is resolved remains until the last word of the scenario, which is presented as a word fragment that the participant must solve, which will typically then assign a benign (rather than threatening) meaning to the scenario.
|
Received CBM-I and Classified High Attrition and no Coach Given
n=263 Participants
Computer- or phone-based Cognitive Bias Modification - Interpretation training
Cognitive Bias Modification - Interpretation training: Training involves presenting participants with brief scenarios that introduce an ambiguous potential threat. Critically, the ambiguity regarding how the situation is resolved remains until the last word of the scenario, which is presented as a word fragment that the participant must solve, which will typically then assign a benign (rather than threatening) meaning to the scenario.
|
Received CBM-I and Classified High Attrition and Given a Coach
n=281 Participants
Computer- or phone-based Cognitive Bias Modification - Interpretation training + Coaching
Cognitive Bias Modification - Interpretation training: Training involves presenting participants with brief scenarios that introduce an ambiguous potential threat. Critically, the ambiguity regarding how the situation is resolved remains until the last word of the scenario, which is presented as a word fragment that the participant must solve, which will typically then assign a benign (rather than threatening) meaning to the scenario.
Coaching: Participants identified as high risk for attrition will receive low-intensity coaching, which includes a mix of brief phone calls, texts, and/or emails with a trained member of the study team to help address challenges with adherence to and application of the training.
|
Psychoeducation
n=241 Participants
Online psychoeducation about anxiety
Online psychoeducation about anxiety: Participants will review webpages that describe information about symptoms and causes of anxiety, including the nature of biased thinking in anxiety.
|
|---|---|---|---|---|---|---|
|
Change in Wellness Measures - Optimism
Baseline
|
1.85 score on a scale
Standard Deviation 1.43
|
1.33 score on a scale
Standard Deviation 1.00
|
1.40 score on a scale
Standard Deviation 0.97
|
1.39 score on a scale
Standard Deviation 0.96
|
1.45 score on a scale
Standard Deviation 1.02
|
1.29 score on a scale
Standard Deviation 0.97
|
|
Change in Wellness Measures - Optimism
Session 3
|
—
|
—
|
1.82 score on a scale
Standard Deviation 0.94
|
1.82 score on a scale
Standard Deviation 1.05
|
1.79 score on a scale
Standard Deviation 1.07
|
1.52 score on a scale
Standard Deviation 0.98
|
|
Change in Wellness Measures - Optimism
Session 5
|
—
|
—
|
1.85 score on a scale
Standard Deviation 1.03
|
1.97 score on a scale
Standard Deviation 1.06
|
1.82 score on a scale
Standard Deviation 1.01
|
1.57 score on a scale
Standard Deviation 0.97
|
|
Change in Wellness Measures - Optimism
2-month Follow-up
|
—
|
—
|
1.93 score on a scale
Standard Deviation 1.03
|
1.84 score on a scale
Standard Deviation 1.08
|
1.95 score on a scale
Standard Deviation 1.07
|
1.65 score on a scale
Standard Deviation 0.93
|
SECONDARY outcome
Timeframe: Baseline, and after session 3 (2-3 weeks following baseline), session 5 (~2 weeks after session 3), & at 2-month follow-up (~ 2 months after session 5). Measure will be completed immediately following that day's training session.Population: Some weeks have less participants reported than overall number analyzed because of attrition - participants did not fill out the survey and thus we do not have data to report on all participants across all weeks.
Items 1, 5, and 7 from the Growth Mindset Measure were administered to measure changes in thinking styles (altered from the original items that reference intelligence). Responses include: 0 = Strongly disagree, 1 = Disagree, 2 = Neutral, 3 = Agree, and 4 = Strongly agree, plus Prefer not to answer. Total aggregate scores can range from 0 to 4 by taking the mean of the 3 items. Higher scores indicate a lack of a growth mindset (AKA more negative outcome). We calculate participants' growth mindset scores by taking the mean of the two items, and we are reporting these mean growth mindset scores below. Questions are: You can learn new things, but you can't really change how you think. No matter how much you have been thinking a particular way, you can always change it quite a bit. You can always substantially change how you think.
Outcome measures
| Measure |
Psychoeducation, Lacking Classification Measures
n=13 Participants
This group started treatment (and had been Stage 1 randomized to psychoeducation) but did not complete Session 1 of psychoeducation plus assessments, so is not part of the classification measure completer sample
|
Received CBM-I and Not Classified as High/Low Risk for Attrition
n=148 Participants
This group started treatment (and had been randomized to CBM-I) but did not complete Session 1 of CBM-I training plus assessments, so was not classified as high/low risk for attrition and thus not randomized for Stage 2 of SMART design
|
Received CBM-I and Classified Low Attrition
n=288 Participants
Computer- or phone-based Cognitive Bias Modification - Interpretation training
Cognitive Bias Modification - Interpretation training: Training involves presenting participants with brief scenarios that introduce an ambiguous potential threat. Critically, the ambiguity regarding how the situation is resolved remains until the last word of the scenario, which is presented as a word fragment that the participant must solve, which will typically then assign a benign (rather than threatening) meaning to the scenario.
|
Received CBM-I and Classified High Attrition and no Coach Given
n=263 Participants
Computer- or phone-based Cognitive Bias Modification - Interpretation training
Cognitive Bias Modification - Interpretation training: Training involves presenting participants with brief scenarios that introduce an ambiguous potential threat. Critically, the ambiguity regarding how the situation is resolved remains until the last word of the scenario, which is presented as a word fragment that the participant must solve, which will typically then assign a benign (rather than threatening) meaning to the scenario.
|
Received CBM-I and Classified High Attrition and Given a Coach
n=281 Participants
Computer- or phone-based Cognitive Bias Modification - Interpretation training + Coaching
Cognitive Bias Modification - Interpretation training: Training involves presenting participants with brief scenarios that introduce an ambiguous potential threat. Critically, the ambiguity regarding how the situation is resolved remains until the last word of the scenario, which is presented as a word fragment that the participant must solve, which will typically then assign a benign (rather than threatening) meaning to the scenario.
Coaching: Participants identified as high risk for attrition will receive low-intensity coaching, which includes a mix of brief phone calls, texts, and/or emails with a trained member of the study team to help address challenges with adherence to and application of the training.
|
Psychoeducation
n=241 Participants
Online psychoeducation about anxiety
Online psychoeducation about anxiety: Participants will review webpages that describe information about symptoms and causes of anxiety, including the nature of biased thinking in anxiety.
|
|---|---|---|---|---|---|---|
|
Change in Wellness Measures - Growth Mindset
Baseline
|
2.13 score on a scale
Standard Deviation 0.44
|
2.17 score on a scale
Standard Deviation 0.57
|
2.14 score on a scale
Standard Deviation 0.50
|
2.12 score on a scale
Standard Deviation 0.55
|
2.10 score on a scale
Standard Deviation 0.51
|
2.13 score on a scale
Standard Deviation 0.53
|
|
Change in Wellness Measures - Growth Mindset
2-month Follow-up
|
—
|
—
|
2.22 score on a scale
Standard Deviation 0.47
|
2.25 score on a scale
Standard Deviation 0.52
|
2.26 score on a scale
Standard Deviation 0.46
|
2.25 score on a scale
Standard Deviation 0.50
|
|
Change in Wellness Measures - Growth Mindset
Session 3
|
—
|
—
|
2.29 score on a scale
Standard Deviation 0.53
|
2.33 score on a scale
Standard Deviation 0.53
|
2.27 score on a scale
Standard Deviation 0.47
|
2.20 score on a scale
Standard Deviation 0.49
|
|
Change in Wellness Measures - Growth Mindset
Session 5
|
—
|
—
|
2.29 score on a scale
Standard Deviation 0.53
|
2.34 score on a scale
Standard Deviation 0.51
|
2.25 score on a scale
Standard Deviation 0.53
|
2.28 score on a scale
Standard Deviation 0.52
|
SECONDARY outcome
Timeframe: Baseline, and after session 3 (2-3 weeks following baseline), session 5 (~2 weeks after session 3), & at 2-month follow-up (~ 2 months after session 5). Measure will be completed immediately following that day's training session.Population: Some weeks have less participants reported than overall number analyzed because of attrition - participants did not fill out the survey and thus we do not have data to report on all participants across all weeks.
Items 2, 6, and 7 from the New General Self-Efficacy Scale (NGSES) will be administered to measure self-efficacy. Item range = 0 to 4. Total aggregate scores can range from 0 to 4 by taking the mean of the 3 items. Higher scores indicate more self-efficacy. We calculate participants' self-efficacy scores by taking the mean of the 3 items.
Outcome measures
| Measure |
Psychoeducation, Lacking Classification Measures
n=13 Participants
This group started treatment (and had been Stage 1 randomized to psychoeducation) but did not complete Session 1 of psychoeducation plus assessments, so is not part of the classification measure completer sample
|
Received CBM-I and Not Classified as High/Low Risk for Attrition
n=148 Participants
This group started treatment (and had been randomized to CBM-I) but did not complete Session 1 of CBM-I training plus assessments, so was not classified as high/low risk for attrition and thus not randomized for Stage 2 of SMART design
|
Received CBM-I and Classified Low Attrition
n=288 Participants
Computer- or phone-based Cognitive Bias Modification - Interpretation training
Cognitive Bias Modification - Interpretation training: Training involves presenting participants with brief scenarios that introduce an ambiguous potential threat. Critically, the ambiguity regarding how the situation is resolved remains until the last word of the scenario, which is presented as a word fragment that the participant must solve, which will typically then assign a benign (rather than threatening) meaning to the scenario.
|
Received CBM-I and Classified High Attrition and no Coach Given
n=263 Participants
Computer- or phone-based Cognitive Bias Modification - Interpretation training
Cognitive Bias Modification - Interpretation training: Training involves presenting participants with brief scenarios that introduce an ambiguous potential threat. Critically, the ambiguity regarding how the situation is resolved remains until the last word of the scenario, which is presented as a word fragment that the participant must solve, which will typically then assign a benign (rather than threatening) meaning to the scenario.
|
Received CBM-I and Classified High Attrition and Given a Coach
n=281 Participants
Computer- or phone-based Cognitive Bias Modification - Interpretation training + Coaching
Cognitive Bias Modification - Interpretation training: Training involves presenting participants with brief scenarios that introduce an ambiguous potential threat. Critically, the ambiguity regarding how the situation is resolved remains until the last word of the scenario, which is presented as a word fragment that the participant must solve, which will typically then assign a benign (rather than threatening) meaning to the scenario.
Coaching: Participants identified as high risk for attrition will receive low-intensity coaching, which includes a mix of brief phone calls, texts, and/or emails with a trained member of the study team to help address challenges with adherence to and application of the training.
|
Psychoeducation
n=241 Participants
Online psychoeducation about anxiety
Online psychoeducation about anxiety: Participants will review webpages that describe information about symptoms and causes of anxiety, including the nature of biased thinking in anxiety.
|
|---|---|---|---|---|---|---|
|
Change in Wellness Measures - Self-efficacy
Baseline
|
2.15 score on a scale
Standard Deviation 1.04
|
2.27 score on a scale
Standard Deviation 0.93
|
2.27 score on a scale
Standard Deviation 0.92
|
2.37 score on a scale
Standard Deviation 0.83
|
2.22 score on a scale
Standard Deviation 0.93
|
2.20 score on a scale
Standard Deviation 0.93
|
|
Change in Wellness Measures - Self-efficacy
Session 3
|
—
|
—
|
2.71 score on a scale
Standard Deviation 0.84
|
2.75 score on a scale
Standard Deviation 0.85
|
2.59 score on a scale
Standard Deviation 0.81
|
2.41 score on a scale
Standard Deviation 0.83
|
|
Change in Wellness Measures - Self-efficacy
Session 5
|
—
|
—
|
2.77 score on a scale
Standard Deviation 0.81
|
2.75 score on a scale
Standard Deviation 0.79
|
2.74 score on a scale
Standard Deviation 0.84
|
2.57 score on a scale
Standard Deviation 0.88
|
|
Change in Wellness Measures - Self-efficacy
2-month Follow-up
|
—
|
—
|
2.75 score on a scale
Standard Deviation 0.75
|
2.82 score on a scale
Standard Deviation 0.74
|
2.75 score on a scale
Standard Deviation 0.78
|
2.58 score on a scale
Standard Deviation 0.80
|
SECONDARY outcome
Timeframe: Baseline, and after session 3 (2-3 weeks following baseline), session 5 (~2 weeks after session 3), & at 2-month follow-up (~ 2 months after session 5). Measure will be completed immediately following that day's training session.Population: Some weeks have less participants reported than overall number analyzed because of attrition - participants did not fill out the survey and thus we do not have data to report on all participants across all weeks.
Single-Item Life Satisfaction measure will be administered to measure overall satisfaction with one's life. Participants are asked "All things considered, how satisfied are you with your life as a whole?" and can choose from the following options, with lower scores being more dissatisfied with life (AKA more negative): 0 (Completely dissatisfied) 1 2 3 4 5 6 7 8 9 10 (Completely satisfied) Prefer not to answer
Outcome measures
| Measure |
Psychoeducation, Lacking Classification Measures
n=13 Participants
This group started treatment (and had been Stage 1 randomized to psychoeducation) but did not complete Session 1 of psychoeducation plus assessments, so is not part of the classification measure completer sample
|
Received CBM-I and Not Classified as High/Low Risk for Attrition
n=148 Participants
This group started treatment (and had been randomized to CBM-I) but did not complete Session 1 of CBM-I training plus assessments, so was not classified as high/low risk for attrition and thus not randomized for Stage 2 of SMART design
|
Received CBM-I and Classified Low Attrition
n=288 Participants
Computer- or phone-based Cognitive Bias Modification - Interpretation training
Cognitive Bias Modification - Interpretation training: Training involves presenting participants with brief scenarios that introduce an ambiguous potential threat. Critically, the ambiguity regarding how the situation is resolved remains until the last word of the scenario, which is presented as a word fragment that the participant must solve, which will typically then assign a benign (rather than threatening) meaning to the scenario.
|
Received CBM-I and Classified High Attrition and no Coach Given
n=263 Participants
Computer- or phone-based Cognitive Bias Modification - Interpretation training
Cognitive Bias Modification - Interpretation training: Training involves presenting participants with brief scenarios that introduce an ambiguous potential threat. Critically, the ambiguity regarding how the situation is resolved remains until the last word of the scenario, which is presented as a word fragment that the participant must solve, which will typically then assign a benign (rather than threatening) meaning to the scenario.
|
Received CBM-I and Classified High Attrition and Given a Coach
n=281 Participants
Computer- or phone-based Cognitive Bias Modification - Interpretation training + Coaching
Cognitive Bias Modification - Interpretation training: Training involves presenting participants with brief scenarios that introduce an ambiguous potential threat. Critically, the ambiguity regarding how the situation is resolved remains until the last word of the scenario, which is presented as a word fragment that the participant must solve, which will typically then assign a benign (rather than threatening) meaning to the scenario.
Coaching: Participants identified as high risk for attrition will receive low-intensity coaching, which includes a mix of brief phone calls, texts, and/or emails with a trained member of the study team to help address challenges with adherence to and application of the training.
|
Psychoeducation
n=241 Participants
Online psychoeducation about anxiety
Online psychoeducation about anxiety: Participants will review webpages that describe information about symptoms and causes of anxiety, including the nature of biased thinking in anxiety.
|
|---|---|---|---|---|---|---|
|
Change in Wellness Measures - Life Satisfaction
Baseline
|
4.31 score on a scale
Standard Deviation 2.50
|
4.71 score on a scale
Standard Deviation 2.28
|
4.77 score on a scale
Standard Deviation 2.22
|
5.09 score on a scale
Standard Deviation 2.16
|
4.95 score on a scale
Standard Deviation 2.14
|
5.01 score on a scale
Standard Deviation 2.18
|
|
Change in Wellness Measures - Life Satisfaction
Session 3
|
—
|
—
|
5.69 score on a scale
Standard Deviation 2.21
|
5.75 score on a scale
Standard Deviation 2.05
|
5.94 score on a scale
Standard Deviation 1.99
|
5.28 score on a scale
Standard Deviation 2.13
|
|
Change in Wellness Measures - Life Satisfaction
Session 5
|
—
|
—
|
5.81 score on a scale
Standard Deviation 2.32
|
6.00 score on a scale
Standard Deviation 2.08
|
6.01 score on a scale
Standard Deviation 1.91
|
5.79 score on a scale
Standard Deviation 2.05
|
|
Change in Wellness Measures - Life Satisfaction
2-month Follow-up
|
—
|
—
|
5.71 score on a scale
Standard Deviation 2.16
|
6.12 score on a scale
Standard Deviation 2.05
|
6.14 score on a scale
Standard Deviation 2.03
|
5.76 score on a scale
Standard Deviation 1.91
|
SECONDARY outcome
Timeframe: Baseline, and after session 3 (2-3 weeks following baseline), session 5 (~2 weeks after session 3), & at 2-month follow-up (~ 2 months after session 5). Measure will be completed immediately following that day's training session.Population: Some weeks have less participants reported than overall number analyzed because of attrition - participants did not fill out the survey and thus we do not have data to report on all participants across all weeks.
Item 14 of the Cognitive Flexibility Inventory (CFI) will be administered to measure cognitive flexibility. Participants are asked "I often look at a situation from different viewpoints." with response options as follows, with higher scores indicating more cognitive flexibility (AKA more positive outcome): 1. = Strongly disagree 2. = Disagree 3. = Somewhat disagree 4. = Neutral 5. = Somewhat agree 6. = Agree 7. = Strongly agree Prefer not to answer
Outcome measures
| Measure |
Psychoeducation, Lacking Classification Measures
n=13 Participants
This group started treatment (and had been Stage 1 randomized to psychoeducation) but did not complete Session 1 of psychoeducation plus assessments, so is not part of the classification measure completer sample
|
Received CBM-I and Not Classified as High/Low Risk for Attrition
n=148 Participants
This group started treatment (and had been randomized to CBM-I) but did not complete Session 1 of CBM-I training plus assessments, so was not classified as high/low risk for attrition and thus not randomized for Stage 2 of SMART design
|
Received CBM-I and Classified Low Attrition
n=288 Participants
Computer- or phone-based Cognitive Bias Modification - Interpretation training
Cognitive Bias Modification - Interpretation training: Training involves presenting participants with brief scenarios that introduce an ambiguous potential threat. Critically, the ambiguity regarding how the situation is resolved remains until the last word of the scenario, which is presented as a word fragment that the participant must solve, which will typically then assign a benign (rather than threatening) meaning to the scenario.
|
Received CBM-I and Classified High Attrition and no Coach Given
n=263 Participants
Computer- or phone-based Cognitive Bias Modification - Interpretation training
Cognitive Bias Modification - Interpretation training: Training involves presenting participants with brief scenarios that introduce an ambiguous potential threat. Critically, the ambiguity regarding how the situation is resolved remains until the last word of the scenario, which is presented as a word fragment that the participant must solve, which will typically then assign a benign (rather than threatening) meaning to the scenario.
|
Received CBM-I and Classified High Attrition and Given a Coach
n=281 Participants
Computer- or phone-based Cognitive Bias Modification - Interpretation training + Coaching
Cognitive Bias Modification - Interpretation training: Training involves presenting participants with brief scenarios that introduce an ambiguous potential threat. Critically, the ambiguity regarding how the situation is resolved remains until the last word of the scenario, which is presented as a word fragment that the participant must solve, which will typically then assign a benign (rather than threatening) meaning to the scenario.
Coaching: Participants identified as high risk for attrition will receive low-intensity coaching, which includes a mix of brief phone calls, texts, and/or emails with a trained member of the study team to help address challenges with adherence to and application of the training.
|
Psychoeducation
n=241 Participants
Online psychoeducation about anxiety
Online psychoeducation about anxiety: Participants will review webpages that describe information about symptoms and causes of anxiety, including the nature of biased thinking in anxiety.
|
|---|---|---|---|---|---|---|
|
Change in Mechanisms Underlying Bias Change - Cognitive Flexibility
Baseline
|
5.54 score on a scale
Standard Deviation 1.05
|
5.20 score on a scale
Standard Deviation 1.41
|
5.20 score on a scale
Standard Deviation 1.43
|
5.25 score on a scale
Standard Deviation 1.38
|
5.17 score on a scale
Standard Deviation 1.51
|
5.04 score on a scale
Standard Deviation 1.44
|
|
Change in Mechanisms Underlying Bias Change - Cognitive Flexibility
Session 3
|
—
|
—
|
5.41 score on a scale
Standard Deviation 1.31
|
5.60 score on a scale
Standard Deviation 1.33
|
5.41 score on a scale
Standard Deviation 1.35
|
5.36 score on a scale
Standard Deviation 1.24
|
|
Change in Mechanisms Underlying Bias Change - Cognitive Flexibility
Session 5
|
—
|
—
|
5.40 score on a scale
Standard Deviation 1.40
|
5.61 score on a scale
Standard Deviation 1.35
|
5.52 score on a scale
Standard Deviation 1.23
|
5.33 score on a scale
Standard Deviation 1.26
|
|
Change in Mechanisms Underlying Bias Change - Cognitive Flexibility
2-month Follow-up
|
—
|
—
|
5.59 score on a scale
Standard Deviation 1.15
|
5.57 score on a scale
Standard Deviation 1.19
|
5.57 score on a scale
Standard Deviation 1.20
|
5.47 score on a scale
Standard Deviation 1.26
|
SECONDARY outcome
Timeframe: Baseline, and after session 3 (2-3 weeks following baseline), session 5 (~2 weeks after session 3), & at 2-month follow-up (~ 2 months after session 5). Measure will be completed immediately following that day's training session.Population: Some weeks have less participants reported than overall number analyzed because of attrition - participants did not fill out the survey and thus we do not have data to report on all participants across all weeks.
Item 11 from the Comprehensive Assessment of ACT processes (CompACT) will be administered to measure experiential avoidance. Participants are asked "I am willing to fully experience whatever thoughts, feelings, and sensations come up for me, without trying to change them." with response options as follows, with higher scores indicating less avoidance (AKA more positive outcome): 1. = Strongly disagree 2. = Disagree 3. = Somewhat disagree 4. = Neutral 5. = Somewhat agree 6. = Agree 7. = Strongly agree Prefer not to answer
Outcome measures
| Measure |
Psychoeducation, Lacking Classification Measures
n=13 Participants
This group started treatment (and had been Stage 1 randomized to psychoeducation) but did not complete Session 1 of psychoeducation plus assessments, so is not part of the classification measure completer sample
|
Received CBM-I and Not Classified as High/Low Risk for Attrition
n=148 Participants
This group started treatment (and had been randomized to CBM-I) but did not complete Session 1 of CBM-I training plus assessments, so was not classified as high/low risk for attrition and thus not randomized for Stage 2 of SMART design
|
Received CBM-I and Classified Low Attrition
n=288 Participants
Computer- or phone-based Cognitive Bias Modification - Interpretation training
Cognitive Bias Modification - Interpretation training: Training involves presenting participants with brief scenarios that introduce an ambiguous potential threat. Critically, the ambiguity regarding how the situation is resolved remains until the last word of the scenario, which is presented as a word fragment that the participant must solve, which will typically then assign a benign (rather than threatening) meaning to the scenario.
|
Received CBM-I and Classified High Attrition and no Coach Given
n=263 Participants
Computer- or phone-based Cognitive Bias Modification - Interpretation training
Cognitive Bias Modification - Interpretation training: Training involves presenting participants with brief scenarios that introduce an ambiguous potential threat. Critically, the ambiguity regarding how the situation is resolved remains until the last word of the scenario, which is presented as a word fragment that the participant must solve, which will typically then assign a benign (rather than threatening) meaning to the scenario.
|
Received CBM-I and Classified High Attrition and Given a Coach
n=281 Participants
Computer- or phone-based Cognitive Bias Modification - Interpretation training + Coaching
Cognitive Bias Modification - Interpretation training: Training involves presenting participants with brief scenarios that introduce an ambiguous potential threat. Critically, the ambiguity regarding how the situation is resolved remains until the last word of the scenario, which is presented as a word fragment that the participant must solve, which will typically then assign a benign (rather than threatening) meaning to the scenario.
Coaching: Participants identified as high risk for attrition will receive low-intensity coaching, which includes a mix of brief phone calls, texts, and/or emails with a trained member of the study team to help address challenges with adherence to and application of the training.
|
Psychoeducation
n=241 Participants
Online psychoeducation about anxiety
Online psychoeducation about anxiety: Participants will review webpages that describe information about symptoms and causes of anxiety, including the nature of biased thinking in anxiety.
|
|---|---|---|---|---|---|---|
|
Change in Mechanisms Underlying Bias Change - Experiential Avoidance
Baseline
|
3.85 score on a scale
Standard Deviation 1.41
|
4.05 score on a scale
Standard Deviation 1.75
|
3.78 score on a scale
Standard Deviation 1.66
|
3.89 score on a scale
Standard Deviation 1.63
|
3.85 score on a scale
Standard Deviation 1.64
|
3.80 score on a scale
Standard Deviation 1.55
|
|
Change in Mechanisms Underlying Bias Change - Experiential Avoidance
Session 3
|
—
|
—
|
4.33 score on a scale
Standard Deviation 1.60
|
4.44 score on a scale
Standard Deviation 1.60
|
3.94 score on a scale
Standard Deviation 1.57
|
4.14 score on a scale
Standard Deviation 1.53
|
|
Change in Mechanisms Underlying Bias Change - Experiential Avoidance
Session 5
|
—
|
—
|
4.56 score on a scale
Standard Deviation 1.55
|
4.72 score on a scale
Standard Deviation 1.41
|
4.43 score on a scale
Standard Deviation 1.56
|
4.25 score on a scale
Standard Deviation 1.48
|
|
Change in Mechanisms Underlying Bias Change - Experiential Avoidance
2-month Follow-up
|
—
|
—
|
4.58 score on a scale
Standard Deviation 1.51
|
4.73 score on a scale
Standard Deviation 1.54
|
4.17 score on a scale
Standard Deviation 1.61
|
4.35 score on a scale
Standard Deviation 1.43
|
SECONDARY outcome
Timeframe: Baseline, and after session 3 (2-3 weeks following baseline), session 5 (~2 weeks after session 3), & at 2-month follow-up (~ 2 months after session 5). Measure will be completed immediately following that day's training session.Population: Some weeks have less participants reported than overall number analyzed because of attrition - participants did not fill out the survey and thus we do not have data to report on all participants across all weeks.
Items 7 and 10 from the Emotion Regulation Questionnaire (ERQ) will be administered to measure cognitive reappraisal. Participants are given two statements - "When I want to feel more positive emotion, I change the way I'm thinking about the situation" and "When I want to feel less negative emotion, I change the way I'm thinking about the situation" - with response options as follows, with higher scores indicating more reappraisal (AKA more positive outcome): 1. = Strongly disagree 2. = Disagree 3. = Somewhat disagree 4. = Neutral 5. = Somewhat agree 6. = Agree 7. = Strongly agree Prefer not to answer Total aggregate scores can range from 0 to 7 by taking the mean of the two items. We calculate participants' Cognitive reappraisal scores by taking the mean of the two items, and we are reporting these mean Cognitive reappraisal scores below.
Outcome measures
| Measure |
Psychoeducation, Lacking Classification Measures
n=13 Participants
This group started treatment (and had been Stage 1 randomized to psychoeducation) but did not complete Session 1 of psychoeducation plus assessments, so is not part of the classification measure completer sample
|
Received CBM-I and Not Classified as High/Low Risk for Attrition
n=148 Participants
This group started treatment (and had been randomized to CBM-I) but did not complete Session 1 of CBM-I training plus assessments, so was not classified as high/low risk for attrition and thus not randomized for Stage 2 of SMART design
|
Received CBM-I and Classified Low Attrition
n=288 Participants
Computer- or phone-based Cognitive Bias Modification - Interpretation training
Cognitive Bias Modification - Interpretation training: Training involves presenting participants with brief scenarios that introduce an ambiguous potential threat. Critically, the ambiguity regarding how the situation is resolved remains until the last word of the scenario, which is presented as a word fragment that the participant must solve, which will typically then assign a benign (rather than threatening) meaning to the scenario.
|
Received CBM-I and Classified High Attrition and no Coach Given
n=263 Participants
Computer- or phone-based Cognitive Bias Modification - Interpretation training
Cognitive Bias Modification - Interpretation training: Training involves presenting participants with brief scenarios that introduce an ambiguous potential threat. Critically, the ambiguity regarding how the situation is resolved remains until the last word of the scenario, which is presented as a word fragment that the participant must solve, which will typically then assign a benign (rather than threatening) meaning to the scenario.
|
Received CBM-I and Classified High Attrition and Given a Coach
n=281 Participants
Computer- or phone-based Cognitive Bias Modification - Interpretation training + Coaching
Cognitive Bias Modification - Interpretation training: Training involves presenting participants with brief scenarios that introduce an ambiguous potential threat. Critically, the ambiguity regarding how the situation is resolved remains until the last word of the scenario, which is presented as a word fragment that the participant must solve, which will typically then assign a benign (rather than threatening) meaning to the scenario.
Coaching: Participants identified as high risk for attrition will receive low-intensity coaching, which includes a mix of brief phone calls, texts, and/or emails with a trained member of the study team to help address challenges with adherence to and application of the training.
|
Psychoeducation
n=241 Participants
Online psychoeducation about anxiety
Online psychoeducation about anxiety: Participants will review webpages that describe information about symptoms and causes of anxiety, including the nature of biased thinking in anxiety.
|
|---|---|---|---|---|---|---|
|
Change in Mechanisms Underlying Bias Change - Cognitive Reappraisal
Baseline
|
4.65 score on a scale
Standard Deviation 1.05
|
4.41 score on a scale
Standard Deviation 1.57
|
4.28 score on a scale
Standard Deviation 1.49
|
4.34 score on a scale
Standard Deviation 1.42
|
4.29 score on a scale
Standard Deviation 1.41
|
4.14 score on a scale
Standard Deviation 1.36
|
|
Change in Mechanisms Underlying Bias Change - Cognitive Reappraisal
Session 3
|
—
|
—
|
4.90 score on a scale
Standard Deviation 1.25
|
4.81 score on a scale
Standard Deviation 1.44
|
4.79 score on a scale
Standard Deviation 1.28
|
4.59 score on a scale
Standard Deviation 1.33
|
|
Change in Mechanisms Underlying Bias Change - Cognitive Reappraisal
Session 5
|
—
|
—
|
5.11 score on a scale
Standard Deviation 1.28
|
4.95 score on a scale
Standard Deviation 1.20
|
4.89 score on a scale
Standard Deviation 1.32
|
4.87 score on a scale
Standard Deviation 1.29
|
|
Change in Mechanisms Underlying Bias Change - Cognitive Reappraisal
2-month Follow-up
|
—
|
—
|
5.00 score on a scale
Standard Deviation 1.20
|
4.96 score on a scale
Standard Deviation 1.18
|
5.01 score on a scale
Standard Deviation 1.18
|
4.92 score on a scale
Standard Deviation 1.11
|
SECONDARY outcome
Timeframe: Baseline, and after session 3 (2-3 weeks following baseline), session 5 (~2 weeks after session 3), & at 2-month follow-up (~ 2 months after session 5). Measure will be completed immediately following that day's training session.Population: Some weeks have less participants reported than overall number analyzed because of attrition - participants did not fill out the survey and thus we do not have data to report on all participants across all weeks.
Items 1 and 7 from the Intolerance of Uncertainty Scale-Short Form (IUS-12) will be administered to measure intolerance of uncertainty. Item range = 1 to 7. Total range for aggregated 2 items = 2-14, with a higher score indicating more intolerance of uncertainty.
Outcome measures
| Measure |
Psychoeducation, Lacking Classification Measures
n=13 Participants
This group started treatment (and had been Stage 1 randomized to psychoeducation) but did not complete Session 1 of psychoeducation plus assessments, so is not part of the classification measure completer sample
|
Received CBM-I and Not Classified as High/Low Risk for Attrition
n=148 Participants
This group started treatment (and had been randomized to CBM-I) but did not complete Session 1 of CBM-I training plus assessments, so was not classified as high/low risk for attrition and thus not randomized for Stage 2 of SMART design
|
Received CBM-I and Classified Low Attrition
n=288 Participants
Computer- or phone-based Cognitive Bias Modification - Interpretation training
Cognitive Bias Modification - Interpretation training: Training involves presenting participants with brief scenarios that introduce an ambiguous potential threat. Critically, the ambiguity regarding how the situation is resolved remains until the last word of the scenario, which is presented as a word fragment that the participant must solve, which will typically then assign a benign (rather than threatening) meaning to the scenario.
|
Received CBM-I and Classified High Attrition and no Coach Given
n=263 Participants
Computer- or phone-based Cognitive Bias Modification - Interpretation training
Cognitive Bias Modification - Interpretation training: Training involves presenting participants with brief scenarios that introduce an ambiguous potential threat. Critically, the ambiguity regarding how the situation is resolved remains until the last word of the scenario, which is presented as a word fragment that the participant must solve, which will typically then assign a benign (rather than threatening) meaning to the scenario.
|
Received CBM-I and Classified High Attrition and Given a Coach
n=281 Participants
Computer- or phone-based Cognitive Bias Modification - Interpretation training + Coaching
Cognitive Bias Modification - Interpretation training: Training involves presenting participants with brief scenarios that introduce an ambiguous potential threat. Critically, the ambiguity regarding how the situation is resolved remains until the last word of the scenario, which is presented as a word fragment that the participant must solve, which will typically then assign a benign (rather than threatening) meaning to the scenario.
Coaching: Participants identified as high risk for attrition will receive low-intensity coaching, which includes a mix of brief phone calls, texts, and/or emails with a trained member of the study team to help address challenges with adherence to and application of the training.
|
Psychoeducation
n=241 Participants
Online psychoeducation about anxiety
Online psychoeducation about anxiety: Participants will review webpages that describe information about symptoms and causes of anxiety, including the nature of biased thinking in anxiety.
|
|---|---|---|---|---|---|---|
|
Change in Mechanisms Underlying Bias Change - Intolerance of Uncertainty
2-month Follow-up
|
—
|
—
|
5.10 score on a scale
Standard Deviation 1.31
|
5.16 score on a scale
Standard Deviation 1.20
|
5.02 score on a scale
Standard Deviation 1.20
|
5.26 score on a scale
Standard Deviation 1.19
|
|
Change in Mechanisms Underlying Bias Change - Intolerance of Uncertainty
Baseline
|
5.62 score on a scale
Standard Deviation 1.16
|
5.42 score on a scale
Standard Deviation 1.27
|
5.57 score on a scale
Standard Deviation 1.11
|
5.56 score on a scale
Standard Deviation 1.14
|
5.65 score on a scale
Standard Deviation 1.12
|
5.53 score on a scale
Standard Deviation 1.23
|
|
Change in Mechanisms Underlying Bias Change - Intolerance of Uncertainty
Session 3
|
—
|
—
|
5.22 score on a scale
Standard Deviation 1.20
|
5.18 score on a scale
Standard Deviation 1.19
|
5.29 score on a scale
Standard Deviation 1.17
|
5.44 score on a scale
Standard Deviation 1.20
|
|
Change in Mechanisms Underlying Bias Change - Intolerance of Uncertainty
Session 5
|
—
|
—
|
5.00 score on a scale
Standard Deviation 1.37
|
5.08 score on a scale
Standard Deviation 1.14
|
5.03 score on a scale
Standard Deviation 1.21
|
5.25 score on a scale
Standard Deviation 1.22
|
SECONDARY outcome
Timeframe: Baseline, and after session 3 (2-3 weeks following baseline), session 5 (~2 weeks after session 3), & at 2-month follow-up (~ 2 months after session 5). Measure will be completed immediately following that day's training session.Population: Some weeks have less participants reported than overall number analyzed because of attrition - participants did not fill out the survey and thus we do not have data to report on all participants across all weeks.
We will assess change in the extent anxiety is viewed as central to the person's self-concept. Participants are asked "To what extent is your anxiety a central part of who you are currently?" and provided with 5 images of two circles, one labeled "My Anxiety" and one labeled "Me", where the circles start off not touching at all and get increasingly closer/overlapped, with the last image having the circles fully overlapped. We code these 5 images as 0 = No overlap, 1 = overlapped about 25%, 2 = overlapped about 50%, 3 = overlapped about 75%, 4 = Fully overlapped; higher scores indicate that anxiety is more central to the person's self-concept, and lower scores indicate that the person does not identify themself with their anxiety.
Outcome measures
| Measure |
Psychoeducation, Lacking Classification Measures
n=13 Participants
This group started treatment (and had been Stage 1 randomized to psychoeducation) but did not complete Session 1 of psychoeducation plus assessments, so is not part of the classification measure completer sample
|
Received CBM-I and Not Classified as High/Low Risk for Attrition
n=148 Participants
This group started treatment (and had been randomized to CBM-I) but did not complete Session 1 of CBM-I training plus assessments, so was not classified as high/low risk for attrition and thus not randomized for Stage 2 of SMART design
|
Received CBM-I and Classified Low Attrition
n=288 Participants
Computer- or phone-based Cognitive Bias Modification - Interpretation training
Cognitive Bias Modification - Interpretation training: Training involves presenting participants with brief scenarios that introduce an ambiguous potential threat. Critically, the ambiguity regarding how the situation is resolved remains until the last word of the scenario, which is presented as a word fragment that the participant must solve, which will typically then assign a benign (rather than threatening) meaning to the scenario.
|
Received CBM-I and Classified High Attrition and no Coach Given
n=263 Participants
Computer- or phone-based Cognitive Bias Modification - Interpretation training
Cognitive Bias Modification - Interpretation training: Training involves presenting participants with brief scenarios that introduce an ambiguous potential threat. Critically, the ambiguity regarding how the situation is resolved remains until the last word of the scenario, which is presented as a word fragment that the participant must solve, which will typically then assign a benign (rather than threatening) meaning to the scenario.
|
Received CBM-I and Classified High Attrition and Given a Coach
n=281 Participants
Computer- or phone-based Cognitive Bias Modification - Interpretation training + Coaching
Cognitive Bias Modification - Interpretation training: Training involves presenting participants with brief scenarios that introduce an ambiguous potential threat. Critically, the ambiguity regarding how the situation is resolved remains until the last word of the scenario, which is presented as a word fragment that the participant must solve, which will typically then assign a benign (rather than threatening) meaning to the scenario.
Coaching: Participants identified as high risk for attrition will receive low-intensity coaching, which includes a mix of brief phone calls, texts, and/or emails with a trained member of the study team to help address challenges with adherence to and application of the training.
|
Psychoeducation
n=241 Participants
Online psychoeducation about anxiety
Online psychoeducation about anxiety: Participants will review webpages that describe information about symptoms and causes of anxiety, including the nature of biased thinking in anxiety.
|
|---|---|---|---|---|---|---|
|
Change in Anxiety and Identity Circles
Baseline
|
2.42 score on a scale
Standard Deviation 0.79
|
2.48 score on a scale
Standard Deviation 0.93
|
2.55 score on a scale
Standard Deviation 0.90
|
2.51 score on a scale
Standard Deviation 0.88
|
2.56 score on a scale
Standard Deviation 0.85
|
2.49 score on a scale
Standard Deviation 0.98
|
|
Change in Anxiety and Identity Circles
Session 3
|
—
|
—
|
1.93 score on a scale
Standard Deviation 0.93
|
1.86 score on a scale
Standard Deviation 0.92
|
2.01 score on a scale
Standard Deviation 0.90
|
2.12 score on a scale
Standard Deviation 0.95
|
|
Change in Anxiety and Identity Circles
Session 5
|
—
|
—
|
1.61 score on a scale
Standard Deviation 1.00
|
1.69 score on a scale
Standard Deviation 0.79
|
1.75 score on a scale
Standard Deviation 0.99
|
1.83 score on a scale
Standard Deviation 0.94
|
|
Change in Anxiety and Identity Circles
2-month Follow-up
|
—
|
—
|
1.57 score on a scale
Standard Deviation 0.88
|
1.54 score on a scale
Standard Deviation 0.85
|
1.57 score on a scale
Standard Deviation 0.89
|
1.78 score on a scale
Standard Deviation 1.01
|
Adverse Events
Received CBM-I and Not Classified as High/Low Risk for Attrition
Received CBM-I and Classified Low Attrition
Received CBM-I and Classified High Attrition and no Coach Given
Received CBM-I and Classified High Attrition and Given a Coach
Psychoeducation
Psychoeducation, Lacking Classification Measures
Not Randomized to Treatment
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Bethany Teachman
University of Virginia Department of Psychology
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place