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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ellen Teng, PhD | Michael E. DeBakey VA Medical Center, Houston, TX | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Michael E. DeBakey VA Medical Center, Houston, TX | Houston | Texas | 77030-4211 | United States |
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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).
Study recruitment occurred from Sept 2022 - Mar 2024 at the Michael E. DeBakey VA Medical Center.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Phase 1 included 8 dyads (8 Family Members; 8 Veterans). Phase 2 included 21 dyads (21 Family Members; 21 Veterans). This only includes dyads who initiated treatment and have follow-up data.
Note: The following data were not collected from family members: Age & BAI.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Phase 2 (Final) - Pilot AF-CBT |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | These data are only available for Veteran participants. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 1-month follow-up |
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Baseline through study completion, an average of 5 months.
Note: Adverse events were not collected from family members.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Visit to ER | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ellen Teng | Michael E. DeBakey VA Medical Center | 713 791-1414 | Ellen.Teng@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 7, 2022 | Apr 28, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 9, 2022 | May 8, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D000098647 | Generalized Anxiety Disorder |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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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.
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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 |
| Withdrawn from study |
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| Lost to Follow-up |
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The final version of Adjunctive Family - Cognitive Behavioral Therapy (AF-CBT) was delivered to family members of Veterans with anxiety during Phase 2. |
| BG002 | Total | Total of all reporting groups |
These data were only collected from Veterans. This information was not collected from Family Members.
| Count of Participants |
| Participants |
|
| Age, Continuous | These numbers represent data collected from Veterans only. This data was not collected from Family Members. | Mean | Standard Deviation | years |
|
| Sex: Female, Male | The number analyzed includes individual participants (Veterans & Family Members) | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | The overall count of 16 in Phase 1 includes data from 8 Veterans and 8 Family Members. The overall count of 42 in Phase 2 includes data from 21 Veterans and 21 Family Members. | Count of Participants | Participants |
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| Race (NIH/OMB) | For Phase 1 the total count of 16 participants includes 8 Veterans and 8 Family Members. For Phase 2 the total count of 42 participants includes 21 Veterans and 21 Family Members. | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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The final version of Adjunctive Family - Cognitive Behavioral Therapy (AF-CBT) was delivered to family members of Veterans with anxiety during Phase 2.
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| Primary | Client Satisfaction Questionnaire | Degree to which participant was satisfied with treatment. Scores range from 8-32, with higher scores reflecting greater satisfaction. | 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. | Posted | Mean | Standard Deviation | score on a scale | 1-month follow-up |
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| 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. | A total of 64 dyads (Veterans & Family Members) were invited to participate in the study. | Posted | Number | dyads | Recruitment Initiation to Recruitment Completion (up to 18 Months) |
|
|
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| 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. | One Veteran in Phase 2 did not complete the BAI at the 1-Month Follow-Up. | Posted | Mean | Standard Deviation | score on a scale | Baseline; 1-Month Follow-Up |
|
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| 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline; 1-Month Follow-Up |
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| 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. | 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. | Posted | Count of Participants | Participants | Baseline to Treatment Completion (average 4 months) |
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| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | 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. | 0 | 21 | 0 | 21 | 2 | 21 |
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| Male |
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| Unknown or Not Reported |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Family Member |
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| 1 Month Veteran |
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| 1 Month Family Member |
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| Baseline Veteran |
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| 1 Month Veteran |
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