Adjunctive Family CBT for Veterans With Anxiety (AF-CBT)

Increasing the Effectiveness of CBT for Anxiety in Veterans by Involving Family Members.

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.

Study Overview

• Status: Completed
• Conditions: Anxiety Disorder
• Intervention / Treatment: Behavioral: Adjunctive Family - Cognitive Behavioral Therapy

Detailed Description

Posttraumatic stress disorder (PTSD) and anxiety disorders such as panic, generalized and social anxiety are highly prevalent among Veterans of all eras and negatively impact functioning and quality of life. Avoidance is a hallmark feature of anxiety and functions to maintain the disorder. Although cognitive behavior therapy (CBT) is effective, a significant proportion of Veterans show minimal improvement following treatment. This is often due to poor treatment adherence such as avoidance of using skills taught in CBT that require confronting distressing memories and feared situations. Avoidance behavior also can extend to caregivers and family members of Veterans, who may engage in accommodation behaviors (i.e., changing their own behaviors) to help alleviate distress experienced by their loved ones. As such, accommodation by family members undermines the effectiveness of CBT and is associated with greater symptom severity and functional impairment in persons with anxiety.

This study will examine the feasibility, acceptability, and satisfaction associated with a new intervention for family members of Veterans undergoing CBT for anxiety-based disorders. Adjunctive Family-CBT (AF-CBT) provides family members psychoeducation on anxiety and teaches skills that can be used to facilitate the recovery of Veterans who are in the process of completing treatment for anxiety. Aims of the study are to: (1) adapt and refine AF-CBT through an iterative process that will be informed by feedback from Veterans and family members; (2) examine the feasibility and acceptability/satisfaction of AF-CBT; (3) assess the validity and reliability of the Family Accommodation Scale-Anxiety adapted for Veterans and family members; and (4) examine the associations between family accommodation behavior and readjustment and anxiety in Veterans.

The proposed study involves a total of 47 Veterans and family member dyads (V/F dyad) and will be conducted in two phases. In phase 1, 12 V/F dyads will be recruited, and family members will receive AF-CBT while the Veteran undergoes iCBT for anxiety. The intervention will be delivered in three separate cohorts (approximately 4 V/F dyad in each cohort). During the 1-month assessment, information obtained from qualitative interviews will be used to refine the intervention in an iterative process with each cohort. In phase 2, 35 V/F dyads will be recruited and administered the finalized version of AF-CBT following the same treatment and assessment format. Qualitative interviews will focus on each V/F dyad's experience with the AF-CBT intervention and whether specific components of the intervention facilitated the Veteran's recovery process.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030-4211
      • Michael E. DeBakey VA Medical Center, Houston, TX

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Study Population

Veterans and adult family members

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Behavioral: Adjunctive Family - Cognitive Behavioral Therapy; AF-CBT provides family members psychoeducation on anxiety and teaches skills to facilitate the recovery of Veterans in the process of completing anxiety treatment.; Other Names: AF-CBT
Other: 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.	Behavioral: Adjunctive Family - Cognitive Behavioral Therapy; AF-CBT provides family members psychoeducation on anxiety and teaches skills to facilitate the recovery of Veterans in the process of completing anxiety treatment.; Other Names: AF-CBT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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)
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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Beck Anxiety Inventory	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.	Baseline; 1-Month Follow-Up
Family Accommodation Scale	Degree to which family member engages in accommodation behaviors. Scores range from 0-36, with higher scores reflecting greater levels of accommodation.	Baseline; 1-Month Follow-Up

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Collaborators: Central Arkansas Veterans Healthcare System
• Investigators: Principal Investigator: Ellen Teng, PhD, Michael E. DeBakey VA Medical Center, Houston, TX

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Actual): April 30, 2024
• Study Completion (Actual): April 30, 2024

Study Registration Dates

• First Submitted: April 15, 2022
• First Submitted That Met QC Criteria: April 15, 2022
• First Posted (Actual): April 22, 2022

Study Record Updates

• Last Update Posted (Estimated): September 5, 2025
• Last Update Submitted That Met QC Criteria: August 25, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: social anxiety; CBT; panic; generalized anxiety
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Generalized Anxiety Disorder
• Other Study ID Numbers: D3863-P

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No