Adjunctive Family CBT for Veterans With Anxiety

NCT05340478 | Completed Results

• 1 other identifier: D3863-P
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anxiety Disorder

Keywords

panic; generalized anxiety; social anxiety; CBT

Outcome Measures

Primary Outcomes (4)

• Modified Treatment Evaluation Inventory

  Degree to which treatment components were found to be acceptable. Scores range from 9-45, with higher scores reflecting greater acceptance of treatment.

  1-month follow-up

• Client Satisfaction Questionnaire

  Degree to which participant was satisfied with treatment. Scores range from 8-32, with higher scores reflecting greater satisfaction.

  1-month follow-up

• Feasibility of Recruitment for AF-CBT

  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.

  Recruitment Initiation to Recruitment Completion (up to 18 Months)

• Feasibility of Retention for AF-CBT

  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.

  Baseline to Treatment Completion (average 4 months)

Secondary Outcomes (2)

• Beck Anxiety Inventory

  Baseline; 1-Month Follow-Up

• Family Accommodation Scale

  Baseline; 1-Month Follow-Up

Study Arms (2)

Phase 1 (Initial) - Adapt/Refine AF-CBT

OTHER

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.

Behavioral: Adjunctive Family - Cognitive Behavioral Therapy

Phase 2 (Final) - Pilot AF-CBT

OTHER

The final version of Adjunctive Family - Cognitive Behavioral Therapy (AF-CBT) was delivered to family members of Veterans with anxiety during Phase 2.

Behavioral: Adjunctive Family - Cognitive Behavioral Therapy

Interventions

Adjunctive Family - Cognitive Behavioral Therapy BEHAVIORAL

AF-CBT provides family members psychoeducation on anxiety and teaches skills to facilitate the recovery of Veterans in the process of completing anxiety treatment.

Also known as: AF-CBT

Phase 1 (Initial) - Adapt/Refine AF-CBT; Phase 2 (Final) - Pilot AF-CBT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, 77030-4211, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Generalized Anxiety Disorder

Condition Hierarchy (Ancestors)

Mental Disorders

Results Point of Contact

• Title: Dr. Ellen Teng
• Organization: Michael E. DeBakey VA Medical Center

Ellen.Teng@va.gov

713 791-1414

Study Officials

• Ellen Teng, PhD

  Michael E. DeBakey VA Medical Center, Houston, TX

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Pilot feasibility trial with 2 phases. Phase 1 involved adapting and refining the AF-CBT intervention. Phase 2 involved a small pilot to assess feasibility of delivering the AF-CBT intervention.

Study Record Dates

• First Submitted: April 15, 2022
• First Posted: April 22, 2022
• Study Start: September 1, 2022
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: September 5, 2025
• Results First Posted: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)