An Adjunctive Family Intervention for Individual Posttraumatic Stress Disorder Treatment

Not Applicable

Completed

• Conditions: Posttraumatic Neuroses
• Interventions: Behavioral: Brief Family Intervention

• Registration Number: NCT02956434
• Lead Sponsor: VA Office of Research and Development

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2016-11-02
• Study First Submitted QC: 2016-11-03
• Study First Posted: 2016-11-06
• Study Start: 2017-09-15
• Primary Completion: 2020-05-05
• Study Completion: 2020-05-05
• Results First Submitted: 2021-09-07
• Results First Submitted QC: 2021-09-07
• Results First Posted: 2021-10-05
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-12
• Last Update Posted: 2021-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Brief family intervention	Brief Family Intervention	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA; 🇺🇸 Boston, Massachusetts, United States