Clinical trial NCT05340478: Adjunctive Family CBT for Veterans With Anxiety
Official title: Increasing the Effectiveness of CBT for Anxiety in Veterans by Involving Family Members.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anxiety Disorder
Keywords: panic
generalized anxiety
social anxiety
CBT
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2022-04-22
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Veterans and adult family members

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.

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.

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.

Primary outcomes:
measure: Modified Treatment Evaluation Inventory
timeFrame: 1-month follow-up
measure: Client Satisfaction Questionnaire
timeFrame: 1-month follow-up
Secondary outcomes:
measure: Beck Anxiety Inventory
timeFrame: Baseline; 1-month follow-up
measure: Family Accommodation Scale
timeFrame: baseline; 1-month follow-up
Other outcomes:
Locations:
city: Houston
country: United States
facility: Michael E. DeBakey VA Medical Center, Houston, TX
state: Texas
Study officials:
affiliation: Michael E. DeBakey VA Medical Center, Houston, TX
name: Ellen Teng, PhD
role: PRINCIPAL_INVESTIGATOR
References: