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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

48 participants

Primary outcome timeframe

1-month follow-up

Results posted on

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

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

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Withdrawn from study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

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-up

Population: 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

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-up

Population: 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

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

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

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-Up

Population: 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

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-Up

Population: 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

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

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Phase 2 (Final) - Pilot AF-CBT

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

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

Dr. Ellen Teng

Michael E. DeBakey VA Medical Center

Phone: 713 791-1414

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place