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Completed

NCT Number: NCT02956434

An Adjunctive Family Intervention for Individual Posttraumatic Stress Disorder Treatment

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

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Key information

Conditions

Posttraumatic Neuroses Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Boston, Massachusetts, 02130, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brief Family Intervention

Behavioral

Two 50-minute sessions aimed at helping family members be most supportive to their loved one's treatment goals.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Significant Others' Responses to Trauma Scale (SORTS)

    Time frame: 16 weeks

    A measure of self-reported family accommodation of PTSD symptoms. Min value = 0, max value = 112. Higher scores mean worse outcome.

  2. Revised Dyadic Adjustment Scale

    Time frame: 16 weeks

    A measure of relationship quality. Min value = 0, max value = 69. Higher scores mean better outcome.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

An Adjunctive Family Intervention for Individual PTSD Treatment

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Nov 7, 2016
Registry last updated
Dec 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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