Adjunctive Family CBT for Veterans With Anxiety (NCT05340478) | Clinical Trial Compass
CompletedNot Applicable
Adjunctive Family CBT for Veterans With Anxiety
United States48 participantsStarted 2022-09-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Modified Treatment Evaluation Inventory
Timeframe: 1-month follow-up
2
Client Satisfaction Questionnaire
Timeframe: 1-month follow-up
3
Feasibility of Recruitment for AF-CBT
Timeframe: Recruitment Initiation to Recruitment Completion (up to 18 Months)
4
Feasibility of Retention for AF-CBT
Timeframe: Baseline to Treatment Completion (average 4 months)