Improving Veteran Adherence to Treatment for PTSD Through Partnering With Families

Posttraumatic Stress Disorder Clinical Trial

Official title:

Improving Veteran Adherence to Treatment for PTSD Through Partnering With Families

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03256227
• Other study ID #: IIR 15-322
• Status: Completed
• Phase: N/A
• Start date: January 15, 2018
• Est. completion date: June 30, 2022

Study information

• Verified date: January 2024
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Impacts. This study aims to improve Veterans' adherence to evidence-based treatment for PTSD, through increasing family support for treatment. Improving retention rates in evidence-based PTSD treatment will positively impact Veterans' health and well-being, lower the cost of treating PTSD, and decrease long-term demand for PTSD services. If effective, this approach could help resolve national calls for routine inclusion of family involvement in PTSD treatment. Once demonstrated for PTSD, these strategies could be utilized for other conditions and problems relevant to Veteran populations (e.g., suicide prevention, traumatic brain injury (TBI) rehabilitation) and stimulate shifts across practice and policy to better routine and evidence-based involvement of families in care. Background. PTSD occurs in as many as 1 in 5 combat Veterans and is associated with a host of negative, long-term consequences to the individual, their families, and society at large. Evidence-based psychotherapies, such as Prolonged Exposure (PE), result in clinically significant symptom relief for many. Yet, adherence to these treatments (i.e., session attendance and homework compliance), which is vital to ensuring recovery, can be poor. Engaging families in Veterans' treatment may provide a powerful method for promoting EBP adherence. The investigators data indicate that 70% of Veterans express some interest in involving their family in their care for PTSD; yet, only 17% of providers have had any contact with Veterans' families. The objective of the proposed study is to evaluate the effectiveness of improving family support as a tool to improve Veterans' EBP adherence. This research agenda directly addresses two VA HSR&D priorities: - innovative mental health care; - improving the quality of life for Veterans and their caregivers. The work aligns with the VHA Blueprint for Excellence and Strategic Plan through meeting the unique needs of military-service disabled Veterans, providing a novel treatment approach, and emphasizing patient- and family-centered care. Objectives/Aims. Aim 1: To improve Veterans' adherence to PE through engaging families in care. H1: Veterans randomized to family supported PE will attend more sessions (H1a) and report greater homework compliance (H1b) than Veterans randomized to standard PE delivered in routine care. Aim 2: To improve the clinical outcomes of Veterans receiving PE through engaging families in care. H2: Family supported PE will be more effective than standard PE in reducing PTSD severity and comorbid problems (depression, quality of life, relationship functioning) from baseline to posttreatment. Aim 3: To examine barriers/facilitators of implementing family support for PE. Exploratory Aim: To identify mechanisms underlying adherence differences between treatment conditions. The investigators will explore if adherence differences are mediated by changes on key social influence variables (family perceptions of treatment credibility, family support for PE, and family symptom accommodation). Methods. The investigators are proposing a practical randomized controlled trial to compare Veteran adherence, and to PE with and without family attendance at PE's educational sessions, with the ultimate goal to improve Veterans' clinical outcomes. For Aim 3, the investigators will use a concurrent process evaluation to identify potential implementation facilitators and barriers to family involvement in PE within VA. Participants will include Veterans with clinically significant symptoms of PTSD across three sites, plus a family member or friend of the Veteran. Aim 1 outcome variables include session attendance and homework compliance. Aim 2 outcomes include PTSD symptom severity, depression, quality of life, and relationship functioning, measured monthly over the course of treatment. Key social influences (Exploratory Aim) will be assessed through brief weekly self-reports.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Male or female veterans at least 18 years old. Recruitment is limited to Veterans enrolled in VHA care.

2. 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).

3. Has an intimate partner, family member, or friend with whom they have contact with at least 3 times a week

4. Willing to allow this person to participate in the study.

5. Provides informed consent.

6. Speaks and reads English.

Exclusion Criteria:

1. Current suicidal or homicidal ideation with intent and/or plan.

2. Meets DSM-5 criteria for a manic of psychotic episode in the past 3 months.

3. 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.

4. 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).

5. Support person screens positive for PTSD on a self-report instrument (PCL).

6. Having an ongoing medical condition that would interfere with ability to attend weekly treatment sessions.

7. Having any planned upcoming major medical procedures over the next several months that would interfere with ability to attend weekly treatment sessions.

8. Veteran and/or SP fails to complete baseline survey

9. Episode of mania/psychosis in past 3 months

Related Conditions & MeSH terms

• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Family Supported Prolonged Exposure
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.
• Standard Prolonged Exposure
Standard Prolonged Exposure for PTSD as delivered in routine VA care.

Locations

Country	Name	City	State
United States	VA Ann Arbor Healthcare System, Ann Arbor, MI	Ann Arbor	Michigan
United States	Atlanta VA Medical and Rehab Center, Decatur, GA	Decatur	Georgia
United States	Minneapolis VA Health Care System, Minneapolis, MN	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & 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. Ca — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Session Attendance	Number of treatment sessions attended by the participant	16 weeks
Secondary	PTSD Checklist for DSM-5 (PCL-5)	The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. Range of scale is 0-80 and can be obtained by summing the scores for each of the 20 items. Higher scores indicate higher PTSD symptom levels.	16 weeks