Trial Outcomes & Findings for Adjunctive Family CBT for Veterans With Anxiety (NCT NCT05340478)
NCT ID: NCT05340478
Last Updated: 2025-09-05
Results Overview
Degree to which treatment components were found to be acceptable. Scores range from 9-45, with higher scores reflecting greater acceptance of treatment.
COMPLETED
NA
48 participants
1-month follow-up
2025-09-05
Participant Flow
Study recruitment occurred from Sept 2022 - Mar 2024 at the Michael E. DeBakey VA Medical Center.
There were a total of 7 dyads (14 participants comprised of 7 Veterans \& 7 Family members) who were excluded after consenting (6 dyads did not meet inclusion criteria; 1 dyad was not clinically appropriate for the study).
Participant milestones
| Measure |
Phase 1 (Initial) - Adapt/Refine AF-CBT
Adjunctive Family - Cognitive Behavioral Therapy (AF-CBT) was adapted and refined for family members of Veterans with anxiety using an iterative process during Phase 1.
|
Phase 2 (Final) - Pilot AF-CBT
The final version of Adjunctive Family - Cognitive Behavioral Therapy (AF-CBT) was delivered to family members of Veterans with anxiety during Phase 2.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
52
|
|
Overall Study
Treatment Initiation
|
21
|
48
|
|
Overall Study
Treatment Completion
|
15
|
42
|
|
Overall Study
Completed Follow Up
|
15
|
40
|
|
Overall Study
COMPLETED
|
15
|
40
|
|
Overall Study
NOT COMPLETED
|
15
|
12
|
Reasons for withdrawal
| Measure |
Phase 1 (Initial) - Adapt/Refine AF-CBT
Adjunctive Family - Cognitive Behavioral Therapy (AF-CBT) was adapted and refined for family members of Veterans with anxiety using an iterative process during Phase 1.
|
Phase 2 (Final) - Pilot AF-CBT
The final version of Adjunctive Family - Cognitive Behavioral Therapy (AF-CBT) was delivered to family members of Veterans with anxiety during Phase 2.
|
|---|---|---|
|
Overall Study
Scheduling Issues
|
10
|
4
|
|
Overall Study
Neither member of dyad started treatment
|
2
|
2
|
|
Overall Study
Withdrawn from study
|
2
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
4
|
Baseline Characteristics
These data were only collected from Veterans. This information was not collected from Family Members.
Baseline characteristics by cohort
| Measure |
Phase 1 (Initial) - Adapt/Refine AF-CBT
n=16 Participants
Adjunctive Family - Cognitive Behavioral Therapy (AF-CBT) was adapted and refined for family members of Veterans with anxiety using an iterative process during Phase 1.
|
Phase 2 (Final) - Pilot AF-CBT
n=42 Participants
The final version of Adjunctive Family - Cognitive Behavioral Therapy (AF-CBT) was delivered to family members of Veterans with anxiety during Phase 2.
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=8 Participants • These data were only collected from Veterans. This information was not collected from Family Members.
|
0 Participants
n=21 Participants • These data were only collected from Veterans. This information was not collected from Family Members.
|
0 Participants
n=29 Participants • These data were only collected from Veterans. This information was not collected from Family Members.
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=8 Participants • These data were only collected from Veterans. This information was not collected from Family Members.
|
21 Participants
n=21 Participants • These data were only collected from Veterans. This information was not collected from Family Members.
|
28 Participants
n=29 Participants • These data were only collected from Veterans. This information was not collected from Family Members.
|
|
Age, Categorical
>=65 years
|
1 Participants
n=8 Participants • These data were only collected from Veterans. This information was not collected from Family Members.
|
0 Participants
n=21 Participants • These data were only collected from Veterans. This information was not collected from Family Members.
|
1 Participants
n=29 Participants • These data were only collected from Veterans. This information was not collected from Family Members.
|
|
Age, Continuous
|
48.13 years
STANDARD_DEVIATION 13.35 • n=8 Participants • These numbers represent data collected from Veterans only. This data was not collected from Family Members.
|
45.62 years
STANDARD_DEVIATION 11.47 • n=21 Participants • These numbers represent data collected from Veterans only. This data was not collected from Family Members.
|
46.31 years
STANDARD_DEVIATION 11.82 • n=29 Participants • These numbers represent data collected from Veterans only. This data was not collected from Family Members.
|
|
Sex: Female, Male
Veterans · Female
|
1 Participants
n=8 Participants • The number analyzed includes individual participants (Veterans \& Family Members)
|
4 Participants
n=21 Participants • The number analyzed includes individual participants (Veterans \& Family Members)
|
5 Participants
n=29 Participants • The number analyzed includes individual participants (Veterans \& Family Members)
|
|
Sex: Female, Male
Veterans · Male
|
7 Participants
n=8 Participants • The number analyzed includes individual participants (Veterans \& Family Members)
|
17 Participants
n=21 Participants • The number analyzed includes individual participants (Veterans \& Family Members)
|
24 Participants
n=29 Participants • The number analyzed includes individual participants (Veterans \& Family Members)
|
|
Sex: Female, Male
Family Members · Female
|
7 Participants
n=8 Participants • The number analyzed includes individual participants (Veterans \& Family Members)
|
16 Participants
n=21 Participants • The number analyzed includes individual participants (Veterans \& Family Members)
|
23 Participants
n=29 Participants • The number analyzed includes individual participants (Veterans \& Family Members)
|
|
Sex: Female, Male
Family Members · Male
|
1 Participants
n=8 Participants • The number analyzed includes individual participants (Veterans \& Family Members)
|
5 Participants
n=21 Participants • The number analyzed includes individual participants (Veterans \& Family Members)
|
6 Participants
n=29 Participants • The number analyzed includes individual participants (Veterans \& Family Members)
|
|
Ethnicity (NIH/OMB)
Veterans · Hispanic or Latino
|
1 Participants
n=8 Participants • The overall count of 16 in Phase 1 includes data from 8 Veterans and 8 Family Members. The overall count of 42 in Phase 2 includes data from 21 Veterans and 21 Family Members.
|
6 Participants
n=21 Participants • The overall count of 16 in Phase 1 includes data from 8 Veterans and 8 Family Members. The overall count of 42 in Phase 2 includes data from 21 Veterans and 21 Family Members.
|
7 Participants
n=29 Participants • The overall count of 16 in Phase 1 includes data from 8 Veterans and 8 Family Members. The overall count of 42 in Phase 2 includes data from 21 Veterans and 21 Family Members.
|
|
Ethnicity (NIH/OMB)
Veterans · Not Hispanic or Latino
|
7 Participants
n=8 Participants • The overall count of 16 in Phase 1 includes data from 8 Veterans and 8 Family Members. The overall count of 42 in Phase 2 includes data from 21 Veterans and 21 Family Members.
|
15 Participants
n=21 Participants • The overall count of 16 in Phase 1 includes data from 8 Veterans and 8 Family Members. The overall count of 42 in Phase 2 includes data from 21 Veterans and 21 Family Members.
|
22 Participants
n=29 Participants • The overall count of 16 in Phase 1 includes data from 8 Veterans and 8 Family Members. The overall count of 42 in Phase 2 includes data from 21 Veterans and 21 Family Members.
|
|
Ethnicity (NIH/OMB)
Veterans · Unknown or Not Reported
|
0 Participants
n=8 Participants • The overall count of 16 in Phase 1 includes data from 8 Veterans and 8 Family Members. The overall count of 42 in Phase 2 includes data from 21 Veterans and 21 Family Members.
|
0 Participants
n=21 Participants • The overall count of 16 in Phase 1 includes data from 8 Veterans and 8 Family Members. The overall count of 42 in Phase 2 includes data from 21 Veterans and 21 Family Members.
|
0 Participants
n=29 Participants • The overall count of 16 in Phase 1 includes data from 8 Veterans and 8 Family Members. The overall count of 42 in Phase 2 includes data from 21 Veterans and 21 Family Members.
|
|
Ethnicity (NIH/OMB)
Family Members · Hispanic or Latino
|
3 Participants
n=8 Participants • The overall count of 16 in Phase 1 includes data from 8 Veterans and 8 Family Members. The overall count of 42 in Phase 2 includes data from 21 Veterans and 21 Family Members.
|
8 Participants
n=21 Participants • The overall count of 16 in Phase 1 includes data from 8 Veterans and 8 Family Members. The overall count of 42 in Phase 2 includes data from 21 Veterans and 21 Family Members.
|
11 Participants
n=29 Participants • The overall count of 16 in Phase 1 includes data from 8 Veterans and 8 Family Members. The overall count of 42 in Phase 2 includes data from 21 Veterans and 21 Family Members.
|
|
Ethnicity (NIH/OMB)
Family Members · Not Hispanic or Latino
|
5 Participants
n=8 Participants • The overall count of 16 in Phase 1 includes data from 8 Veterans and 8 Family Members. The overall count of 42 in Phase 2 includes data from 21 Veterans and 21 Family Members.
|
12 Participants
n=21 Participants • The overall count of 16 in Phase 1 includes data from 8 Veterans and 8 Family Members. The overall count of 42 in Phase 2 includes data from 21 Veterans and 21 Family Members.
|
17 Participants
n=29 Participants • The overall count of 16 in Phase 1 includes data from 8 Veterans and 8 Family Members. The overall count of 42 in Phase 2 includes data from 21 Veterans and 21 Family Members.
|
|
Ethnicity (NIH/OMB)
Family Members · Unknown or Not Reported
|
0 Participants
n=8 Participants • The overall count of 16 in Phase 1 includes data from 8 Veterans and 8 Family Members. The overall count of 42 in Phase 2 includes data from 21 Veterans and 21 Family Members.
|
1 Participants
n=21 Participants • The overall count of 16 in Phase 1 includes data from 8 Veterans and 8 Family Members. The overall count of 42 in Phase 2 includes data from 21 Veterans and 21 Family Members.
|
1 Participants
n=29 Participants • The overall count of 16 in Phase 1 includes data from 8 Veterans and 8 Family Members. The overall count of 42 in Phase 2 includes data from 21 Veterans and 21 Family Members.
|
|
Race (NIH/OMB)
Veteran · American Indian or Alaska Native
|
0 Participants
n=8 Participants • For Phase 1 the total count of 16 participants includes 8 Veterans and 8 Family Members. For Phase 2 the total count of 42 participants includes 21 Veterans and 21 Family Members.
|
0 Participants
n=21 Participants • For Phase 1 the total count of 16 participants includes 8 Veterans and 8 Family Members. For Phase 2 the total count of 42 participants includes 21 Veterans and 21 Family Members.
|
0 Participants
n=29 Participants • For Phase 1 the total count of 16 participants includes 8 Veterans and 8 Family Members. For Phase 2 the total count of 42 participants includes 21 Veterans and 21 Family Members.
|
|
Race (NIH/OMB)
Veteran · Asian
|
1 Participants
n=8 Participants • For Phase 1 the total count of 16 participants includes 8 Veterans and 8 Family Members. For Phase 2 the total count of 42 participants includes 21 Veterans and 21 Family Members.
|
0 Participants
n=21 Participants • For Phase 1 the total count of 16 participants includes 8 Veterans and 8 Family Members. For Phase 2 the total count of 42 participants includes 21 Veterans and 21 Family Members.
|
1 Participants
n=29 Participants • For Phase 1 the total count of 16 participants includes 8 Veterans and 8 Family Members. For Phase 2 the total count of 42 participants includes 21 Veterans and 21 Family Members.
|
|
Race (NIH/OMB)
Veteran · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=8 Participants • For Phase 1 the total count of 16 participants includes 8 Veterans and 8 Family Members. For Phase 2 the total count of 42 participants includes 21 Veterans and 21 Family Members.
|
0 Participants
n=21 Participants • For Phase 1 the total count of 16 participants includes 8 Veterans and 8 Family Members. For Phase 2 the total count of 42 participants includes 21 Veterans and 21 Family Members.
|
0 Participants
n=29 Participants • For Phase 1 the total count of 16 participants includes 8 Veterans and 8 Family Members. For Phase 2 the total count of 42 participants includes 21 Veterans and 21 Family Members.
|
|
Race (NIH/OMB)
Veteran · Black or African American
|
0 Participants
n=8 Participants • For Phase 1 the total count of 16 participants includes 8 Veterans and 8 Family Members. For Phase 2 the total count of 42 participants includes 21 Veterans and 21 Family Members.
|
3 Participants
n=21 Participants • For Phase 1 the total count of 16 participants includes 8 Veterans and 8 Family Members. For Phase 2 the total count of 42 participants includes 21 Veterans and 21 Family Members.
|
3 Participants
n=29 Participants • For Phase 1 the total count of 16 participants includes 8 Veterans and 8 Family Members. For Phase 2 the total count of 42 participants includes 21 Veterans and 21 Family Members.
|
|
Race (NIH/OMB)
Veteran · White
|
4 Participants
n=8 Participants • For Phase 1 the total count of 16 participants includes 8 Veterans and 8 Family Members. For Phase 2 the total count of 42 participants includes 21 Veterans and 21 Family Members.
|
15 Participants
n=21 Participants • For Phase 1 the total count of 16 participants includes 8 Veterans and 8 Family Members. For Phase 2 the total count of 42 participants includes 21 Veterans and 21 Family Members.
|
19 Participants
n=29 Participants • For Phase 1 the total count of 16 participants includes 8 Veterans and 8 Family Members. For Phase 2 the total count of 42 participants includes 21 Veterans and 21 Family Members.
|
|
Race (NIH/OMB)
Veteran · More than one race
|
3 Participants
n=8 Participants • For Phase 1 the total count of 16 participants includes 8 Veterans and 8 Family Members. For Phase 2 the total count of 42 participants includes 21 Veterans and 21 Family Members.
|
1 Participants
n=21 Participants • For Phase 1 the total count of 16 participants includes 8 Veterans and 8 Family Members. For Phase 2 the total count of 42 participants includes 21 Veterans and 21 Family Members.
|
4 Participants
n=29 Participants • For Phase 1 the total count of 16 participants includes 8 Veterans and 8 Family Members. For Phase 2 the total count of 42 participants includes 21 Veterans and 21 Family Members.
|
|
Race (NIH/OMB)
Veteran · Unknown or Not Reported
|
0 Participants
n=8 Participants • For Phase 1 the total count of 16 participants includes 8 Veterans and 8 Family Members. For Phase 2 the total count of 42 participants includes 21 Veterans and 21 Family Members.
|
2 Participants
n=21 Participants • For Phase 1 the total count of 16 participants includes 8 Veterans and 8 Family Members. For Phase 2 the total count of 42 participants includes 21 Veterans and 21 Family Members.
|
2 Participants
n=29 Participants • For Phase 1 the total count of 16 participants includes 8 Veterans and 8 Family Members. For Phase 2 the total count of 42 participants includes 21 Veterans and 21 Family Members.
|
|
Race (NIH/OMB)
Family Member · American Indian or Alaska Native
|
0 Participants
n=8 Participants • For Phase 1 the total count of 16 participants includes 8 Veterans and 8 Family Members. For Phase 2 the total count of 42 participants includes 21 Veterans and 21 Family Members.
|
0 Participants
n=21 Participants • For Phase 1 the total count of 16 participants includes 8 Veterans and 8 Family Members. For Phase 2 the total count of 42 participants includes 21 Veterans and 21 Family Members.
|
0 Participants
n=29 Participants • For Phase 1 the total count of 16 participants includes 8 Veterans and 8 Family Members. For Phase 2 the total count of 42 participants includes 21 Veterans and 21 Family Members.
|
|
Race (NIH/OMB)
Family Member · Asian
|
1 Participants
n=8 Participants • For Phase 1 the total count of 16 participants includes 8 Veterans and 8 Family Members. For Phase 2 the total count of 42 participants includes 21 Veterans and 21 Family Members.
|
0 Participants
n=21 Participants • For Phase 1 the total count of 16 participants includes 8 Veterans and 8 Family Members. For Phase 2 the total count of 42 participants includes 21 Veterans and 21 Family Members.
|
1 Participants
n=29 Participants • For Phase 1 the total count of 16 participants includes 8 Veterans and 8 Family Members. For Phase 2 the total count of 42 participants includes 21 Veterans and 21 Family Members.
|
|
Race (NIH/OMB)
Family Member · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=8 Participants • For Phase 1 the total count of 16 participants includes 8 Veterans and 8 Family Members. For Phase 2 the total count of 42 participants includes 21 Veterans and 21 Family Members.
|
0 Participants
n=21 Participants • For Phase 1 the total count of 16 participants includes 8 Veterans and 8 Family Members. For Phase 2 the total count of 42 participants includes 21 Veterans and 21 Family Members.
|
0 Participants
n=29 Participants • For Phase 1 the total count of 16 participants includes 8 Veterans and 8 Family Members. For Phase 2 the total count of 42 participants includes 21 Veterans and 21 Family Members.
|
|
Race (NIH/OMB)
Family Member · Black or African American
|
1 Participants
n=8 Participants • For Phase 1 the total count of 16 participants includes 8 Veterans and 8 Family Members. For Phase 2 the total count of 42 participants includes 21 Veterans and 21 Family Members.
|
3 Participants
n=21 Participants • For Phase 1 the total count of 16 participants includes 8 Veterans and 8 Family Members. For Phase 2 the total count of 42 participants includes 21 Veterans and 21 Family Members.
|
4 Participants
n=29 Participants • For Phase 1 the total count of 16 participants includes 8 Veterans and 8 Family Members. For Phase 2 the total count of 42 participants includes 21 Veterans and 21 Family Members.
|
|
Race (NIH/OMB)
Family Member · White
|
5 Participants
n=8 Participants • For Phase 1 the total count of 16 participants includes 8 Veterans and 8 Family Members. For Phase 2 the total count of 42 participants includes 21 Veterans and 21 Family Members.
|
10 Participants
n=21 Participants • For Phase 1 the total count of 16 participants includes 8 Veterans and 8 Family Members. For Phase 2 the total count of 42 participants includes 21 Veterans and 21 Family Members.
|
15 Participants
n=29 Participants • For Phase 1 the total count of 16 participants includes 8 Veterans and 8 Family Members. For Phase 2 the total count of 42 participants includes 21 Veterans and 21 Family Members.
|
|
Race (NIH/OMB)
Family Member · More than one race
|
0 Participants
n=8 Participants • For Phase 1 the total count of 16 participants includes 8 Veterans and 8 Family Members. For Phase 2 the total count of 42 participants includes 21 Veterans and 21 Family Members.
|
5 Participants
n=21 Participants • For Phase 1 the total count of 16 participants includes 8 Veterans and 8 Family Members. For Phase 2 the total count of 42 participants includes 21 Veterans and 21 Family Members.
|
5 Participants
n=29 Participants • For Phase 1 the total count of 16 participants includes 8 Veterans and 8 Family Members. For Phase 2 the total count of 42 participants includes 21 Veterans and 21 Family Members.
|
|
Race (NIH/OMB)
Family Member · Unknown or Not Reported
|
1 Participants
n=8 Participants • For Phase 1 the total count of 16 participants includes 8 Veterans and 8 Family Members. For Phase 2 the total count of 42 participants includes 21 Veterans and 21 Family Members.
|
3 Participants
n=21 Participants • For Phase 1 the total count of 16 participants includes 8 Veterans and 8 Family Members. For Phase 2 the total count of 42 participants includes 21 Veterans and 21 Family Members.
|
4 Participants
n=29 Participants • For Phase 1 the total count of 16 participants includes 8 Veterans and 8 Family Members. For Phase 2 the total count of 42 participants includes 21 Veterans and 21 Family Members.
|
|
Region of Enrollment
United States
|
16 Participants
n=16 Participants
|
42 Participants
n=42 Participants
|
58 Participants
n=58 Participants
|
PRIMARY outcome
Timeframe: 1-month follow-upPopulation: In Phase 1, 1 family member did not complete this measure. In Phase 2, 1 Veteran and 2 Family Members did not complete this measure.
Degree to which treatment components were found to be acceptable. Scores range from 9-45, with higher scores reflecting greater acceptance of treatment.
Outcome measures
| Measure |
Phase 1 (Initial) - Adapt/Refine AF-CBT
n=15 Participants
Adjunctive Family - Cognitive Behavioral Therapy (AF-CBT) was adapted and refined for family members of Veterans with anxiety using an iterative process during Phase 1.
|
Phase 2 (Final) - Pilot AF-CBT
n=39 Participants
The final version of Adjunctive Family - Cognitive Behavioral Therapy (AF-CBT) was delivered to family members of Veterans with anxiety during Phase 2.
|
|---|---|---|
|
Modified Treatment Evaluation Inventory
Veteran
|
32.13 score on a scale
Standard Deviation 3.31
|
35.40 score on a scale
Standard Deviation 5.11
|
|
Modified Treatment Evaluation Inventory
Family Member
|
34.29 score on a scale
Standard Deviation 4.07
|
35.32 score on a scale
Standard Deviation 4.73
|
PRIMARY outcome
Timeframe: 1-month follow-upPopulation: In Phase 1, 1 family member did not complete this measure. In Phase 2, 1 Veteran and 2 Family Members did not complete this measure.
Degree to which participant was satisfied with treatment. Scores range from 8-32, with higher scores reflecting greater satisfaction.
Outcome measures
| Measure |
Phase 1 (Initial) - Adapt/Refine AF-CBT
n=15 Participants
Adjunctive Family - Cognitive Behavioral Therapy (AF-CBT) was adapted and refined for family members of Veterans with anxiety using an iterative process during Phase 1.
|
Phase 2 (Final) - Pilot AF-CBT
n=39 Participants
The final version of Adjunctive Family - Cognitive Behavioral Therapy (AF-CBT) was delivered to family members of Veterans with anxiety during Phase 2.
|
|---|---|---|
|
Client Satisfaction Questionnaire
Veteran
|
26.63 score on a scale
Standard Deviation 3.16
|
28.60 score on a scale
Standard Deviation 3.62
|
|
Client Satisfaction Questionnaire
Family Member
|
27.00 score on a scale
Standard Deviation 3.16
|
28.42 score on a scale
Standard Deviation 3.66
|
PRIMARY outcome
Timeframe: Recruitment Initiation to Recruitment Completion (up to 18 Months)Population: A total of 64 dyads (Veterans \& Family Members) were invited to participate in the study.
This outcome pertains to the feasibility of recruiting participant dyads for the AF-CBT intervention across Phases 1 and 2 of the study. The rate of recruitment is based on the number of dyads who agreed to participate out of those invited during the active recruitment period for this study.
Outcome measures
| Measure |
Phase 1 (Initial) - Adapt/Refine AF-CBT
n=64 Participants
Adjunctive Family - Cognitive Behavioral Therapy (AF-CBT) was adapted and refined for family members of Veterans with anxiety using an iterative process during Phase 1.
|
Phase 2 (Final) - Pilot AF-CBT
The final version of Adjunctive Family - Cognitive Behavioral Therapy (AF-CBT) was delivered to family members of Veterans with anxiety during Phase 2.
|
|---|---|---|
|
Feasibility of Recruitment for AF-CBT
|
48 dyads
|
—
|
PRIMARY outcome
Timeframe: Baseline to Treatment Completion (average 4 months)Population: In Phase 1, of the 30 participants (Veterans \& Family Members) enrolled, 15 completed treatment. In Phase 2, of the 52 participants (Veterans \& Family Members) enrolled, 39 completed treatment.
This outcome pertains to the feasibility of retaining participant dyads for the AF-CBT intervention across Phases 1 and 2 of the study. The rate of retention is the percentage of dyads who complete AF-CBT by attending all sessions.
Outcome measures
| Measure |
Phase 1 (Initial) - Adapt/Refine AF-CBT
n=30 Participants
Adjunctive Family - Cognitive Behavioral Therapy (AF-CBT) was adapted and refined for family members of Veterans with anxiety using an iterative process during Phase 1.
|
Phase 2 (Final) - Pilot AF-CBT
n=52 Participants
The final version of Adjunctive Family - Cognitive Behavioral Therapy (AF-CBT) was delivered to family members of Veterans with anxiety during Phase 2.
|
|---|---|---|
|
Feasibility of Retention for AF-CBT
|
15 Participants
|
39 Participants
|
SECONDARY outcome
Timeframe: Baseline; 1-Month Follow-UpPopulation: One Veteran in Phase 2 did not complete the BAI at the 1-Month Follow-Up.
Measure of anxiety including cognitive and somatic components of anxiety. Scores range from 0-63, with higher scores reflecting higher levels of anxiety. Note: The BAI was not collected from family members.
Outcome measures
| Measure |
Phase 1 (Initial) - Adapt/Refine AF-CBT
n=8 Participants
Adjunctive Family - Cognitive Behavioral Therapy (AF-CBT) was adapted and refined for family members of Veterans with anxiety using an iterative process during Phase 1.
|
Phase 2 (Final) - Pilot AF-CBT
n=21 Participants
The final version of Adjunctive Family - Cognitive Behavioral Therapy (AF-CBT) was delivered to family members of Veterans with anxiety during Phase 2.
|
|---|---|---|
|
Beck Anxiety Inventory
Baseline Veteran
|
35.00 score on a scale
Standard Deviation 11.20
|
32.62 score on a scale
Standard Deviation 11.74
|
|
Beck Anxiety Inventory
1 Month Veteran
|
31.25 score on a scale
Standard Deviation 17.25
|
19.20 score on a scale
Standard Deviation 12.63
|
SECONDARY outcome
Timeframe: Baseline; 1-Month Follow-UpPopulation: In Phase 1, 1 family member did not complete this measure at the 1-month follow-up. In Phase 2, 1 Veteran and 2 Family Members did not complete this measure at the 1-month follow-up.
Degree to which family member engages in accommodation behaviors. Scores range from 0-36, with higher scores reflecting greater levels of accommodation.
Outcome measures
| Measure |
Phase 1 (Initial) - Adapt/Refine AF-CBT
n=16 Participants
Adjunctive Family - Cognitive Behavioral Therapy (AF-CBT) was adapted and refined for family members of Veterans with anxiety using an iterative process during Phase 1.
|
Phase 2 (Final) - Pilot AF-CBT
n=42 Participants
The final version of Adjunctive Family - Cognitive Behavioral Therapy (AF-CBT) was delivered to family members of Veterans with anxiety during Phase 2.
|
|---|---|---|
|
Family Accommodation Scale
Baseline Family Member
|
21.75 units on a scale
Standard Deviation 8.45
|
19.86 units on a scale
Standard Deviation 8.51
|
|
Family Accommodation Scale
1 Month Family Member
|
25.00 units on a scale
Standard Deviation 7.83
|
15.05 units on a scale
Standard Deviation 7.60
|
|
Family Accommodation Scale
Baseline Veteran
|
20.50 units on a scale
Standard Deviation 9.07
|
19.62 units on a scale
Standard Deviation 9.21
|
|
Family Accommodation Scale
1 Month Veteran
|
19.75 units on a scale
Standard Deviation 8.14
|
18.00 units on a scale
Standard Deviation 9.41
|
Adverse Events
Phase 1 (Initial) - Adapt/Refine AF-CBT
Phase 2 (Final) - Pilot AF-CBT
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Phase 1 (Initial) - Adapt/Refine AF-CBT
n=8 participants at risk
Adjunctive Family - Cognitive Behavioral Therapy (AF-CBT) was adapted and refined for family members of Veterans with anxiety using an iterative process during Phase 1.
|
Phase 2 (Final) - Pilot AF-CBT
n=21 participants at risk
The final version of Adjunctive Family - Cognitive Behavioral Therapy (AF-CBT) was delivered to family members of Veterans with anxiety during Phase 2.
|
|---|---|---|
|
General disorders
Visit to ER
|
0.00%
0/8 • Baseline through study completion, an average of 5 months.
Note: Adverse events were not collected from family members.
|
9.5%
2/21 • Number of events 3 • Baseline through study completion, an average of 5 months.
Note: Adverse events were not collected from family members.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place