Trial Outcomes & Findings for Developing a Low-Intensity Primary Care Intervention for Anxiety Disorders (AIM-PC) (NCT NCT02579915)
NCT ID: NCT02579915
Last Updated: 2020-02-07
Results Overview
Number of participants who achieved a 20% reduction in their interview-administered Hamilton Anxiety Rating Scale Total Score.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
6-8 weeks after first treatment session
Results posted on
2020-02-07
Participant Flow
Participant milestones
| Measure |
FaceAnxiety - Mental Habits
Treatment will consist of 8, 30-minute, twice-weekly sessions designed to: a) decrease attention bias to threat and b) extinguish threat interpretations/reinforce benign interpretations of ambiguity. Attention bias will be modified via a dot probe task that increases attentional control by directing attention away from threat faces via probe location. Patients will complete 256 trials per session. Interpretation bias will be modified via a word-sentence association task which provides positive feedback when participants endorse benign interpretations of ambiguous sentences and negative feedback for threat interpretations. Participants will complete 150 training trials per session. A FaceAnxiety Specialist facilitates program completion.
FaceAnxiety: Computerized treatment targeting mental habits and primary care linkage.
Symptom Tracking: Weekly self-assessment with validated questionnaires and primary care linkage
|
FaceAnxiety - Symptom Tracking
Treatment will consist of weekly self-assessment of anxiety and depression symptoms via on-line surveys. A FaceAnxiety Specialist will facilitate program completion.
Symptom Tracking: Weekly self-assessment with validated questionnaires and primary care linkage
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
21
|
|
Overall Study
COMPLETED
|
9
|
16
|
|
Overall Study
NOT COMPLETED
|
10
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
1 participant from each arm did not provide their age. These data are missing.
Baseline characteristics by cohort
| Measure |
FaceAnxiety - Mental Habits
n=19 Participants
Treatment will consist of 8, 30-minute, twice-weekly sessions designed to: a) decrease attention bias to threat and b) extinguish threat interpretations/reinforce benign interpretations of ambiguity. Attention bias will be modified via a dot probe task that increases attentional control by directing attention away from threat faces via probe location. Patients will complete 256 trials per session. Interpretation bias will be modified via a word-sentence association task which provides positive feedback when participants endorse benign interpretations of ambiguous sentences and negative feedback for threat interpretations. Participants will complete 150 training trials per session. A FaceAnxiety Specialist facilitates program completion.
FaceAnxiety: Computerized treatment targeting mental habits and primary care linkage.
Symptom Tracking: Weekly self-assessment with validated questionnaires and primary care linkage
|
FaceAnxiety - Symptom Tracking
n=21 Participants
Treatment will consist of weekly self-assessment of anxiety and depression symptoms via on-line surveys. A FaceAnxiety Specialist will facilitate program completion.
Symptom Tracking: Weekly self-assessment with validated questionnaires and primary care linkage
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=18 Participants • 1 participant from each arm did not provide their age. These data are missing.
|
0 Participants
n=20 Participants • 1 participant from each arm did not provide their age. These data are missing.
|
0 Participants
n=38 Participants • 1 participant from each arm did not provide their age. These data are missing.
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=18 Participants • 1 participant from each arm did not provide their age. These data are missing.
|
18 Participants
n=20 Participants • 1 participant from each arm did not provide their age. These data are missing.
|
35 Participants
n=38 Participants • 1 participant from each arm did not provide their age. These data are missing.
|
|
Age, Categorical
>=65 years
|
1 Participants
n=18 Participants • 1 participant from each arm did not provide their age. These data are missing.
|
2 Participants
n=20 Participants • 1 participant from each arm did not provide their age. These data are missing.
|
3 Participants
n=38 Participants • 1 participant from each arm did not provide their age. These data are missing.
|
|
Age, Continuous
|
42.6 years
STANDARD_DEVIATION 14.16 • n=18 Participants • Note that one participant in each arm did not provide age data. Thus, total number of baseline participants differs from those analyzed for age.
|
41.1 years
STANDARD_DEVIATION 15.88 • n=20 Participants • Note that one participant in each arm did not provide age data. Thus, total number of baseline participants differs from those analyzed for age.
|
42.1 years
STANDARD_DEVIATION 14.93 • n=38 Participants • Note that one participant in each arm did not provide age data. Thus, total number of baseline participants differs from those analyzed for age.
|
|
Sex: Female, Male
Female
|
14 Participants
n=19 Participants • 1 participant in the symptom monitoring arm did not provide their sex on the demographic form. This data is missing.
|
16 Participants
n=20 Participants • 1 participant in the symptom monitoring arm did not provide their sex on the demographic form. This data is missing.
|
30 Participants
n=39 Participants • 1 participant in the symptom monitoring arm did not provide their sex on the demographic form. This data is missing.
|
|
Sex: Female, Male
Male
|
5 Participants
n=19 Participants • 1 participant in the symptom monitoring arm did not provide their sex on the demographic form. This data is missing.
|
4 Participants
n=20 Participants • 1 participant in the symptom monitoring arm did not provide their sex on the demographic form. This data is missing.
|
9 Participants
n=39 Participants • 1 participant in the symptom monitoring arm did not provide their sex on the demographic form. This data is missing.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=19 Participants
|
5 Participants
n=21 Participants
|
5 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=19 Participants
|
8 Participants
n=21 Participants
|
22 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=19 Participants
|
8 Participants
n=21 Participants
|
13 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=19 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=19 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=19 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=19 Participants
|
1 Participants
n=21 Participants
|
4 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=19 Participants
|
13 Participants
n=21 Participants
|
27 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=19 Participants
|
4 Participants
n=21 Participants
|
6 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=19 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=40 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=19 Participants
|
21 participants
n=21 Participants
|
40 participants
n=40 Participants
|
PRIMARY outcome
Timeframe: 6-8 weeks after first treatment sessionPopulation: We only analyzed participants who completed their post-treatment assessment, which is required to calculate their % reduction in symptoms.
Number of participants who achieved a 20% reduction in their interview-administered Hamilton Anxiety Rating Scale Total Score.
Outcome measures
| Measure |
FaceAnxiety - Mental Habits
n=8 Participants
Treatment will consist of 8, 30-minute, twice-weekly sessions designed to: a) decrease attention bias to threat and b) extinguish threat interpretations/reinforce benign interpretations of ambiguity. Attention bias will be modified via a dot probe task that increases attentional control by directing attention away from threat faces via probe location. Patients will complete 256 trials per session. Interpretation bias will be modified via a word-sentence association task which provides positive feedback when participants endorse benign interpretations of ambiguous sentences and negative feedback for threat interpretations. Participants will complete 150 training trials per session. A FaceAnxiety Specialist facilitates program completion.
FaceAnxiety: Computerized treatment targeting mental habits and primary care linkage.
Symptom Tracking: Weekly self-assessment with validated questionnaires and primary care linkage
|
FaceAnxiety - Symptom Tracking
n=16 Participants
Treatment will consist of weekly self-assessment of anxiety and depression symptoms via on-line surveys. A FaceAnxiety Specialist will facilitate program completion.
Symptom Tracking: Weekly self-assessment with validated questionnaires and primary care linkage
|
|---|---|---|
|
Hamilton Anxiety Rating Scale
|
5 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 6-8 weeks after first treatment sessionOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6-8 weeks after first treatment sessionOutcome measures
Outcome data not reported
Adverse Events
FaceAnxiety - Mental Habits
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
FaceAnxiety - Symptom Tracking
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
FaceAnxiety - Mental Habits
n=19 participants at risk
Treatment will consist of 8, 30-minute, twice-weekly sessions designed to: a) decrease attention bias to threat and b) extinguish threat interpretations/reinforce benign interpretations of ambiguity. Attention bias will be modified via a dot probe task that increases attentional control by directing attention away from threat faces via probe location. Patients will complete 256 trials per session. Interpretation bias will be modified via a word-sentence association task which provides positive feedback when participants endorse benign interpretations of ambiguous sentences and negative feedback for threat interpretations. Participants will complete 150 training trials per session. A FaceAnxiety Specialist facilitates program completion.
FaceAnxiety: Computerized treatment targeting mental habits and primary care linkage.
Symptom Tracking: Weekly self-assessment with validated questionnaires and primary care linkage
|
FaceAnxiety - Symptom Tracking
n=21 participants at risk
Treatment will consist of weekly self-assessment of anxiety and depression symptoms via on-line surveys. A FaceAnxiety Specialist will facilitate program completion.
Symptom Tracking: Weekly self-assessment with validated questionnaires and primary care linkage
|
|---|---|---|
|
Psychiatric disorders
suicide attempt
|
0.00%
0/19 • Participants were followed for 3 months following their post-treatment assessment. Thus, in total participants were followed for up to 6 months depending on how quickly they completed the treatment.
|
4.8%
1/21 • Number of events 1 • Participants were followed for 3 months following their post-treatment assessment. Thus, in total participants were followed for up to 6 months depending on how quickly they completed the treatment.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place