An Adjunctive Family Intervention for Individual Posttraumatic Stress Disorder Treatment

Study Overview
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Brief Summary
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This study aims to test a brief family intervention (the BFI) to enhance individually-delivered PTSD treatment for Veterans.

Detailed Description
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The investigators will enroll pairs of Veterans and one adult family member who lives with them. Veterans will be beginning a course of PTSD-focused treatment at the Boston VA; Veterans' treatment will not be limited or changed by their participation in this study. Family members will receive or not receive (depending on which Phase of the study they are recruited in) the BFI. The BFI consists of 2 sessions in which the family member meets one-on-one with a clinician to discuss PTSD, PTSD treatment, and how families can be most helpful to patients in treatment. Veterans and family members will also be interviewed about their opinions and experiences regarding family-inclusive treatment for PTSD. Clinicians will be recruited and enrolled to obtain their information and feedback (via qualitative interviews), and to deliver the intervention in Phase II.

Official Title
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An Adjunctive Family Intervention for Individual PTSD Treatment

Conditions
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Posttraumatic Neuroses

Intervention / Treatment
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* Behavioral: Brief Family Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Veterans must have a diagnosis of PTSD and be beginning a course of Prolonged Exposure (PE) or Cognitive Processing Therapy (CPT) at the Boston VA. Must also have an eligible family member who is willing to participate. Exclusion Criteria: Current diagnosis of unstable bipolar disorder, substance dependence, past or present psychosis, or organic mental disorder Clear and current suicidal risk Current participation in family/couples therapy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brief family intervention<br>Participants will receive the BFI in this arm of the study. The BFI is a 2-session intervention for family members of Veterans who are beginning PTSD treatment. | Behavioral: Brief Family Intervention<br>* Two 50-minute sessions aimed at helping family members be most supportive to their loved one's treatment goals.<br>|
| No Intervention: No intervention<br>Participants will not receive the BFI in this arm of the study. They will be eligible for any usual support or programming for the families of Veterans. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinician-Administered PTSD Scale, 5th Edition | A measure of PTSD severity and diagnostic status. Min value = 0, max value = 80. Higher scores mean worse outcome. | 16 weeks | 
| Treatment Attendance/Dropout | A measure of Veterans' treatment attendance or premature dropout. Data represents the Veterans who dropped out of their standard-care PTSD treatment. | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Significant Others' Responses to Trauma Scale (SORTS) | A measure of self-reported family accommodation of PTSD symptoms. Min value = 0, max value = 112. Higher scores mean worse outcome. | 16 weeks | 
| Revised Dyadic Adjustment Scale | A measure of relationship quality. Min value = 0, max value = 69. Higher scores mean better outcome. | 16 weeks |