Trial Outcomes & Findings for Augmenting Hospitalization for Serious Mental Illness: Cognitive Bias Modification (NCT NCT03509181)
NCT ID: NCT03509181
Last Updated: 2024-02-07
Results Overview
Self-reported improvement rating. Outcome is number of participants who reported feeling much or very much improved.
COMPLETED
NA
68 participants
Post-treatment (1 month following discharge from hospital) (up to 8 weeks following baseline)
2024-02-07
Participant Flow
Participant milestones
| Measure |
Cognitive Bias Modification + Symptom Tracking
Cognitive Bias Modification for Interpretation delivered via smartphone
I-Change: smartphone delivered word-sentence association task that encourages a healthier interpretive style
Symptom Tracking: smartphone delivered self-monitoring of anxiety and depression symptoms
|
Symptom Tracking
Weekly symptom monitoring smartphone app with anxiety and depression symptom scores
Symptom Tracking: smartphone delivered self-monitoring of anxiety and depression symptoms
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
34
|
|
Overall Study
COMPLETED
|
27
|
31
|
|
Overall Study
NOT COMPLETED
|
7
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
One participant did not identify as Male or Female
Baseline characteristics by cohort
| Measure |
Cognitive Bias Modification + Symptom Tracking
n=34 Participants
Cognitive Bias Modification for Interpretation delivered via smartphone
I-Change: smartphone delivered word-sentence association task that encourages a healthier interpretive style
Symptom Tracking: smartphone delivered self-monitoring of anxiety and depression symptoms
|
Symptom Tracking
n=34 Participants
Weekly symptom monitoring smartphone app with anxiety and depression symptom scores
Symptom Tracking: smartphone delivered self-monitoring of anxiety and depression symptoms
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
30.29 years
STANDARD_DEVIATION 10.853 • n=34 Participants
|
32.326 years
STANDARD_DEVIATION 13.256 • n=34 Participants
|
31.28 years
STANDARD_DEVIATION 12.064 • n=68 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=33 Participants • One participant did not identify as Male or Female
|
24 Participants
n=34 Participants • One participant did not identify as Male or Female
|
45 Participants
n=67 Participants • One participant did not identify as Male or Female
|
|
Sex: Female, Male
Male
|
12 Participants
n=33 Participants • One participant did not identify as Male or Female
|
10 Participants
n=34 Participants • One participant did not identify as Male or Female
|
22 Participants
n=67 Participants • One participant did not identify as Male or Female
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=34 Participants
|
2 Participants
n=34 Participants
|
4 Participants
n=68 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
32 Participants
n=34 Participants
|
32 Participants
n=34 Participants
|
64 Participants
n=68 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=34 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=68 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=34 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=68 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=34 Participants
|
1 Participants
n=34 Participants
|
3 Participants
n=68 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=34 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=68 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=34 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=68 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=34 Participants
|
29 Participants
n=34 Participants
|
57 Participants
n=68 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=34 Participants
|
4 Participants
n=34 Participants
|
7 Participants
n=68 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=34 Participants
|
0 Participants
n=34 Participants
|
1 Participants
n=68 Participants
|
|
Region of Enrollment
United States
|
34 participants
n=34 Participants
|
34 participants
n=34 Participants
|
68 participants
n=68 Participants
|
PRIMARY outcome
Timeframe: Post-treatment (1 month following discharge from hospital) (up to 8 weeks following baseline)Population: Participants who completed the 1-month follow-up assessment and provided a Clinical Global Improvement rating.
Self-reported improvement rating. Outcome is number of participants who reported feeling much or very much improved.
Outcome measures
| Measure |
Cognitive Bias Modification + Symptom Tracking
n=25 Participants
Cognitive Bias Modification for Interpretation delivered via smartphone
I-Change: smartphone delivered word-sentence association task that encourages a healthier interpretive style
Symptom Tracking: smartphone delivered self-monitoring of anxiety and depression symptoms
|
Symptom Tracking
n=30 Participants
Weekly symptom monitoring smartphone app with anxiety and depression symptom scores
Symptom Tracking: smartphone delivered self-monitoring of anxiety and depression symptoms
|
|---|---|---|
|
Clinical Global Improvement Scale (CGIS)
|
14 Participants
|
20 Participants
|
PRIMARY outcome
Timeframe: Post-treatment (1 month following discharge from hospital)(up to 8 weeks following baseline)Population: Participants who completed the 1-month assessment and completed the WSAS
The Work and Social Adjustment Scale assesses interference caused by the patient's symptoms in the domains of work, home management, leisure, and family relationships. It includes 5 items each rated from 0 to 8 with total scores ranging from 0 to 40 and higher scores indicating more impairment.
Outcome measures
| Measure |
Cognitive Bias Modification + Symptom Tracking
n=25 Participants
Cognitive Bias Modification for Interpretation delivered via smartphone
I-Change: smartphone delivered word-sentence association task that encourages a healthier interpretive style
Symptom Tracking: smartphone delivered self-monitoring of anxiety and depression symptoms
|
Symptom Tracking
n=30 Participants
Weekly symptom monitoring smartphone app with anxiety and depression symptom scores
Symptom Tracking: smartphone delivered self-monitoring of anxiety and depression symptoms
|
|---|---|---|
|
5-item Work and Social Adjustment Scale
|
19.08 score on a scale
Standard Deviation 11.416
|
17.43 score on a scale
Standard Deviation 8.617
|
SECONDARY outcome
Timeframe: Post-treatment (1 month following discharge from hospital) (up to 8 weeks following baseline)Population: Participants who completed the 1-month assessment and the QLESQ (note: missing 1 participant in CBM arm who did not complete the QLESQ).
The Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q-SF) is a 16 item questionnaire that asks about life satisfaction over the past week. Each question is rated on a 5 point scale from 1 (Very Poor) to 5 (Very Good). Scores from the individual items are added together and reported as percentage maximum possible score. The Total Score is reported as percentage maximum possible % Max = Raw-minimum score/maximum score-minimum score. (Raw score minus the minimum possible raw score divided by the maximum possible raw score minus the minimum possible raw score). Higher scores indicate better quality of life.
Outcome measures
| Measure |
Cognitive Bias Modification + Symptom Tracking
n=24 Participants
Cognitive Bias Modification for Interpretation delivered via smartphone
I-Change: smartphone delivered word-sentence association task that encourages a healthier interpretive style
Symptom Tracking: smartphone delivered self-monitoring of anxiety and depression symptoms
|
Symptom Tracking
n=30 Participants
Weekly symptom monitoring smartphone app with anxiety and depression symptom scores
Symptom Tracking: smartphone delivered self-monitoring of anxiety and depression symptoms
|
|---|---|---|
|
Quality of Life Enjoyment and Satisfaction Questionnaire
|
45.58 percentage of max possible score
Standard Deviation 10.5
|
44.83 percentage of max possible score
Standard Deviation 7.40
|
Adverse Events
Cognitive Bias Modification + Symptom Tracking
Symptom Tracking
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place