Anxiety Disorder
Conditions
Keywords
panic, generalized anxiety, social anxiety, CBT
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.
Interventions
BEHAVIORALAdjunctive 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.
Sponsors
VA Office of Research and Development
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Modified Treatment Evaluation Inventory | 1-month follow-up | Degree to which treatment components were found to be acceptable. Scores range from 9-45, with higher scores reflecting greater acceptance of treatment. |
| Client Satisfaction Questionnaire | 1-month follow-up | Degree to which participant was satisfied with treatment. Scores range from 8-32, with higher scores reflecting greater satisfaction. |
| Feasibility of Recruitment for AF-CBT | Recruitment Initiation to Recruitment Completion (up to 18 Months) | 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. |
| Feasibility of Retention for AF-CBT | Baseline to Treatment Completion (average 4 months) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Beck Anxiety Inventory | Baseline; 1-Month Follow-Up | 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. |
| Family Accommodation Scale | Baseline; 1-Month Follow-Up | Degree to which family member engages in accommodation behaviors. Scores range from 0-36, with higher scores reflecting greater levels of accommodation. |
Countries
United States
Participant flow
Recruitment details
Study recruitment occurred from Sept 2022 - Mar 2024 at the Michael E. DeBakey VA Medical Center.
Pre-assignment details
There were a total of 7 dyads (14 participants comprised of 7 Veterans & 7 Family members) who were excluded after consenting (6 dyads did not meet inclusion criteria; 1 dyad was not clinically appropriate for the study).
Participants by arm
| Arm | Count |
|---|---|
| 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. | 16 |
| 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. | 42 |
| Total | 58 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 4 |
| Overall Study | Neither member of dyad started treatment | 2 | 2 |
| Overall Study | Scheduling Issues | 10 | 4 |
| Overall Study | Withdrawn from study | 2 | 2 |
Baseline characteristics
| Characteristic | Phase 1 (Initial) - Adapt/Refine AF-CBT | Phase 2 (Final) - Pilot AF-CBT | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants | 21 Participants | 28 Participants |
| Age, Continuous | 48.13 years STANDARD_DEVIATION 13.35 | 45.62 years STANDARD_DEVIATION 11.47 | 46.31 years STANDARD_DEVIATION 11.82 |
| Ethnicity (NIH/OMB) Family Members Hispanic or Latino | 3 Participants | 8 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Family Members Not Hispanic or Latino | 5 Participants | 12 Participants | 17 Participants |
| Ethnicity (NIH/OMB) Family Members Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Veterans Hispanic or Latino | 1 Participants | 6 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Veterans Not Hispanic or Latino | 7 Participants | 15 Participants | 22 Participants |
| Ethnicity (NIH/OMB) Veterans Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Family Member American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Family Member Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Family Member Black or African American | 1 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) Family Member More than one race | 0 Participants | 5 Participants | 5 Participants |
| Race (NIH/OMB) Family Member Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Family Member Unknown or Not Reported | 1 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) Family Member White | 5 Participants | 10 Participants | 15 Participants |
| Race (NIH/OMB) Veteran American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Veteran Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Veteran Black or African American | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) Veteran More than one race | 3 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) Veteran Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Veteran Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Veteran White | 4 Participants | 15 Participants | 19 Participants |
| Region of Enrollment United States | 16 Participants | 42 Participants | 58 Participants |
| Sex: Female, Male Family Members Female | 7 Participants | 16 Participants | 23 Participants |
| Sex: Female, Male Family Members Male | 1 Participants | 5 Participants | 6 Participants |
| Sex: Female, Male Veterans Female | 1 Participants | 4 Participants | 5 Participants |
| Sex: Female, Male Veterans Male | 7 Participants | 17 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 21 |
| other Total, other adverse events | 0 / 8 | 2 / 21 |
| serious Total, serious adverse events | 0 / 8 | 0 / 21 |
Outcome results
Primary
Client Satisfaction Questionnaire
Degree to which participant was satisfied with treatment. Scores range from 8-32, with higher scores reflecting greater satisfaction.
Time frame: 1-month follow-up
Population: In Phase 1, 1 family member did not complete this measure. In Phase 2, 1 Veteran and 2 Family Members did not complete this measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 1 (Initial) - Adapt/Refine AF-CBT | Client Satisfaction Questionnaire | Veteran | 26.63 score on a scale | Standard Deviation 3.16 |
| Phase 1 (Initial) - Adapt/Refine AF-CBT | Client Satisfaction Questionnaire | Family Member | 27.00 score on a scale | Standard Deviation 3.16 |
| Phase 2 (Final) - Pilot AF-CBT | Client Satisfaction Questionnaire | Veteran | 28.60 score on a scale | Standard Deviation 3.62 |
| Phase 2 (Final) - Pilot AF-CBT | Client Satisfaction Questionnaire | Family Member | 28.42 score on a scale | Standard Deviation 3.66 |
Primary
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.
Time frame: Recruitment Initiation to Recruitment Completion (up to 18 Months)
Population: A total of 64 dyads (Veterans \& Family Members) were invited to participate in the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 1 (Initial) - Adapt/Refine AF-CBT | Feasibility of Recruitment for AF-CBT | 48 dyads |
Primary
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.
Time frame: Baseline to Treatment Completion (average 4 months)
Population: In Phase 1, of the 30 participants (Veterans \& Family Members) enrolled, 15 completed treatment. In Phase 2, of the 52 participants (Veterans \& Family Members) enrolled, 39 completed treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Phase 1 (Initial) - Adapt/Refine AF-CBT | Feasibility of Retention for AF-CBT | 15 Participants |
| Phase 2 (Final) - Pilot AF-CBT | Feasibility of Retention for AF-CBT | 39 Participants |
Primary
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.
Time frame: 1-month follow-up
Population: In Phase 1, 1 family member did not complete this measure. In Phase 2, 1 Veteran and 2 Family Members did not complete this measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 1 (Initial) - Adapt/Refine AF-CBT | Modified Treatment Evaluation Inventory | Veteran | 32.13 score on a scale | Standard Deviation 3.31 |
| Phase 1 (Initial) - Adapt/Refine AF-CBT | Modified Treatment Evaluation Inventory | Family Member | 34.29 score on a scale | Standard Deviation 4.07 |
| Phase 2 (Final) - Pilot AF-CBT | Modified Treatment Evaluation Inventory | Veteran | 35.40 score on a scale | Standard Deviation 5.11 |
| Phase 2 (Final) - Pilot AF-CBT | Modified Treatment Evaluation Inventory | Family Member | 35.32 score on a scale | Standard Deviation 4.73 |
Secondary
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.
Time frame: Baseline; 1-Month Follow-Up
Population: One Veteran in Phase 2 did not complete the BAI at the 1-Month Follow-Up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 1 (Initial) - Adapt/Refine AF-CBT | Beck Anxiety Inventory | Baseline Veteran | 35.00 score on a scale | Standard Deviation 11.2 |
| Phase 1 (Initial) - Adapt/Refine AF-CBT | Beck Anxiety Inventory | 1 Month Veteran | 31.25 score on a scale | Standard Deviation 17.25 |
| Phase 2 (Final) - Pilot AF-CBT | Beck Anxiety Inventory | Baseline Veteran | 32.62 score on a scale | Standard Deviation 11.74 |
| Phase 2 (Final) - Pilot AF-CBT | Beck Anxiety Inventory | 1 Month Veteran | 19.20 score on a scale | Standard Deviation 12.63 |
p-value: <0.001t-test, 2 sided
Secondary
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.
Time frame: Baseline; 1-Month Follow-Up
Population: In Phase 1, 1 family member did not complete this measure at the 1-month follow-up. In Phase 2, 1 Veteran and 2 Family Members did not complete this measure at the 1-month follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 1 (Initial) - Adapt/Refine AF-CBT | Family Accommodation Scale | Baseline Family Member | 21.75 units on a scale | Standard Deviation 8.45 |
| Phase 1 (Initial) - Adapt/Refine AF-CBT | Family Accommodation Scale | Baseline Veteran | 20.50 units on a scale | Standard Deviation 9.07 |
| Phase 1 (Initial) - Adapt/Refine AF-CBT | Family Accommodation Scale | 1 Month Family Member | 25.00 units on a scale | Standard Deviation 7.83 |
| Phase 1 (Initial) - Adapt/Refine AF-CBT | Family Accommodation Scale | 1 Month Veteran | 19.75 units on a scale | Standard Deviation 8.14 |
| Phase 2 (Final) - Pilot AF-CBT | Family Accommodation Scale | 1 Month Family Member | 15.05 units on a scale | Standard Deviation 7.6 |
| Phase 2 (Final) - Pilot AF-CBT | Family Accommodation Scale | Baseline Family Member | 19.86 units on a scale | Standard Deviation 8.51 |
| Phase 2 (Final) - Pilot AF-CBT | Family Accommodation Scale | 1 Month Veteran | 18.00 units on a scale | Standard Deviation 9.41 |
| Phase 2 (Final) - Pilot AF-CBT | Family Accommodation Scale | Baseline Veteran | 19.62 units on a scale | Standard Deviation 9.21 |