Improving Veteran Adherence to Treatment for PTSD Through Partnering With Families

NCT03256227 | Completed Results DMC

• 1 other identifier: IIR 15-322
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 3

Brief Summary

Evidence-based psychotherapies (EBP) for PTSD, such as Prolonged Exposure (PE), result in clinically significant symptom relief for many. Yet, adherence to this treatment (i.e., session attendance and homework compliance), which is vital to ensuring recovery, can be poor. This project will test the effectiveness of improving family support for PE as a tool to improve Veterans' PE adherence. Reducing rates of dropout from PE will positively impact Veterans' health and well-being and lower the cost of treating PTSD. Additionally, despite congressional legislation and national mandates within VA/DoD for family involvement in PTSD care, there remains no proven strategies for how to routinely include family in traditional individual (i.e., one-on-one) EBPs for PTSD. This proposal will provide the initial test of a model of family engagement that can be translated to other problems faced by Veterans, including suicide prevention, traumatic brain injury (TBI) rehabilitation, and pain management, contributing to a broader evolution towards evidence-based, family-inclusive care.

Conditions

Posttraumatic Stress Disorder

Keywords

Posttraumatic Stress Disorder; family therapy; patient adherence; Prolonged Exposure Therapy

Outcome Measures

Primary Outcomes (1)

• Session Attendance

  Number of treatment sessions attended by the participant

  16 weeks

Secondary Outcomes (1)

• PTSD Checklist for DSM-5 (PCL-5)

  16 weeks

Study Arms (2)

Family Supported Prolonged Exposure

EXPERIMENTAL

The investigators propose to bring a family member into early educational sessions of PE, one of the most researched and efficacious treatments for PTSD, to increase family support for PE adherence. Strategies for how to engage with families are drawn from existing evidence-based approaches, including Motivational Interviewing and Behavioral Couples Therapy.

Behavioral: Family Supported Prolonged Exposure

Standard Prolonged Exposure

ACTIVE COMPARATOR

Standard Prolonged Exposure for PTSD as delivered in routine VA care.

Behavioral: Standard Prolonged Exposure

Interventions

Family Supported Prolonged Exposure BEHAVIORAL

The investigators propose to bring a family member into early educational sessions of PE, one of the most researched and efficacious treatments for PTSD, to increase family support for PE adherence. Strategies for how to engage with families are drawn from existing evidence-based approaches, including Motivational Interviewing and Behavioral Couples Therapy.

Family Supported Prolonged Exposure

Standard Prolonged Exposure BEHAVIORAL

Standard Prolonged Exposure for PTSD as delivered in routine VA care.

Standard Prolonged Exposure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female veterans at least 18 years old. Recruitment is limited to Veterans enrolled in VHA care.
• Participant meets DSM-5 diagnostic criteria for PTSD or subthreshold PTSD. Consistent with recommendations, subthreshold PTSD will be defined as endorsement of criteria A (trauma), F (duration), and G (impairment), with at least one symptom from each of the remaining diagnostic criteria (Brancu et al., 2016).
• Has an intimate partner, family member, or friend with whom they have contact with at least 3 times a week
• Willing to allow this person to participate in the study.
• Provides informed consent.
• Speaks and reads English.

You may not qualify if:

• Current suicidal or homicidal ideation with intent and/or plan.
• Meets DSM-5 criteria for a manic of psychotic episode in the past 3 months.
• Meets DSM-5 diagnostic criteria for a severe substance use disorder in the past 3 months. Of note, subjects can be abusing or dependent upon nicotine or marijuana and still be included in the study.
• Moderate relationship violence between the identified support person and the Veteran, defined as one or more episodes of severe violence in the past year (e.g., punched, kicked, or beat up).
• Support person screens positive for PTSD on a self-report instrument (PCL).
• Having an ongoing medical condition that would interfere with ability to attend weekly treatment sessions.
• Having any planned upcoming major medical procedures over the next several months that would interfere with ability to attend weekly treatment sessions.
• Veteran and/or SP fails to complete baseline survey
• Episode of mania/psychosis in past 3 months

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (3)

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia, 30033, United States

Location

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, 48105, United States

Location

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, 55417, United States

Location

Related Publications (1)

• Meis LA, Glynn SM, Spoont MR, Kehle-Forbes SM, Nelson D, Isenhart CE, Eftekhari A, Ackland PE, Linden EB, Orazem RJ, Cutting A, Hagel Campbell EM, Astin MC, Porter KE, Smith E, Chuick CD, Lamp KE, Vuper TC, Oakley TA, Khan LB, Keckeisen SK, Polusny MA. Can families help veterans get more from PTSD treatment? A randomized clinical trial examining Prolonged Exposure with and without family involvement. Trials. 2022 Mar 30;23(1):243. doi: 10.1186/s13063-022-06183-2.

  PMID: 35354481 RESULT

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Patient Compliance

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Limitations and Caveats

Smaller number of subjects analyzed than originally proposed

Results Point of Contact

• Title: Laura Meis, PhD
• Organization: Minneapolis VA Health Care System

laura.meis@va.gov

612-467-4516

Study Officials

• Laura A. Meis, PhD

  Minneapolis VA Health Care System, Minneapolis, MN

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessors are blinded to treatment condition
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: effectiveness-implementation Hybrid 1, 2-arm, pragmatic randomized controlled trial

Study Record Dates

• First Submitted: August 9, 2017
• First Posted: August 21, 2017
• Study Start: January 15, 2018
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: June 14, 2024
• Results First Posted: June 14, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)