An Adjunctive Family Intervention for Individual Posttraumatic Stress Disorder Treatment

An Adjunctive Family Intervention for Individual PTSD Treatment

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

Study Overview

• Status: Completed
• Conditions: Posttraumatic Neuroses
• Intervention / Treatment: Behavioral: Brief Family Intervention

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02130
      • VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Brief Family Intervention; Two 50-minute sessions aimed at helping family members be most supportive to their loved one's treatment goals.
No Intervention: No intervention; 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?

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

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Johanna Thompson-Hollands, PhD, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2017
• Primary Completion (Actual): May 5, 2020
• Study Completion (Actual): May 5, 2020

Study Registration Dates

• First Submitted: November 2, 2016
• First Submitted That Met QC Criteria: November 3, 2016
• First Posted (Estimate): November 6, 2016

Study Record Updates

• Last Update Posted (Actual): December 8, 2021
• Last Update Submitted That Met QC Criteria: November 12, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: MHBB-013-16F; IK2CX001589 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data may be released to other researchers as VA policy allows.
• IPD Sharing Time Frame: Entire study (baseline to 16 weeks)
• IPD Sharing Access Criteria: As per VA policy and local IRB approval
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No