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Clinical Trials/NCT02956434
NCT02956434
Completed
N/A

An Adjunctive Family Intervention for Individual PTSD Treatment

VA Office of Research and Development1 site in 1 country40 target enrollmentSeptember 15, 2017

Overview

Phase
N/A
Intervention
Not specified
Conditions
Posttraumatic Neuroses
Sponsor
VA Office of Research and Development
Enrollment
40
Locations
1
Primary Endpoint
Treatment Attendance/Dropout
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 15, 2017
End Date
May 5, 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Treatment Attendance/Dropout

Time Frame: 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

Time Frame: 16 weeks

A measure of PTSD severity and diagnostic status. Min value = 0, max value = 80. Higher scores mean worse outcome.

Secondary Outcomes

  • Significant Others' Responses to Trauma Scale (SORTS)(16 weeks)
  • Revised Dyadic Adjustment Scale(16 weeks)

Study Sites (1)

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