N/A
N=82
Adjunctive Family CBT for Veterans With Anxiety
Anxiety Disorder
Bottom Line
View on ClinicalTrials.gov: NCT05340478 ↗Enrolled (actual)
82
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcome: Primary: Modified Treatment Evaluation Inventory — 32.13; 35.40; 34.29; 35.32 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Adjunctive Family - Cognitive Behavioral Therapy (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Apr 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Modified Treatment Evaluation Inventory |
32.13; 35.40; 34.29; 35.32 | — |
| PRIMARY Client Satisfaction Questionnaire |
26.63; 28.60; 27.00; 28.42 | — |
| PRIMARY Feasibility of Recruitment for AF-CBT |
48 | — |
| PRIMARY Feasibility of Retention for AF-CBT |
15; 39 | — |
| SECONDARY Beck Anxiety Inventory |
35.00; 32.62; 31.25; 19.20 | <.001 sig |
| SECONDARY Family Accommodation Scale |
21.75; 19.86; 25.00; 15.05; 20.50; 19.62 | — |
Summary
Despite the prevalence of posttraumatic stress disorder and anxiety disorders among Veterans, there has been limited focus on the development of interventions that include family members in treatments provided to Veterans. This is a feasibility study that examines a novel adjunct intervention (Adjunctive Family-Cognitive Behavioral Therapy; AF-CBT) developed for family members of Veterans undergoing behavioral treatment for anxiety-based disorders. Phase one involves piloting AF-CBT with family members and conducting qualitative interviews to obtain feedback about the utility and acceptability of the intervention. The refined protocol will be used in phase two, which involves an open trial where Veterans and family members will complete the intervention and attend a 1-month follow up assessment, including a qualitative interview.
Eligibility Criteria
Inclusion Criteria
- Veteran at least 18 years old;
- current diagnosis of at least one anxiety-based disorder: PTSD, PD, SAD, or GAD (based on ADIS-5);
- moderate-to-poor life enjoyment and satisfaction as indicated by a score of 47 or lower on the Q-LES-Q-SF
- BAI score of 16 (moderate anxiety) or higher;
- stable on psychotropic medication for 4 weeks before study participation; and
- has a family member willing to participate in the study
Exclusion Criteria
- Active symptoms of mania or psychosis at baseline (based on ADIS-5);
- depression with active suicidal ideation/intent that would preclude treatment (based on ADIS-5 & BAI);
- moderate-to-severe cognitive impairment as indicated by a score below 20 on the SLUMS;
- active drug/alcohol abuse during the initial 3-months of study enrollment (otherwise Veterans with comorbid substance/alcohol dependence are study eligible); and
- undergoing concurrent transdiagnostic CBT for anxiety.
Data sourced from ClinicalTrials.gov (NCT05340478). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.