Clinical trial NCT03256227: Improving Veteran Adherence to Treatment for PTSD Through Partnering With Families
Official title: Improving Veteran Adherence to Treatment for PTSD Through Partnering With Families
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Disorder
Keywords: Posttraumatic Stress Disorder
family therapy
patient adherence
Prolonged Exposure Therapy
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2017-08-21
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: effectiveness-implementation Hybrid 1, 2-arm, pragmatic randomized controlled trial
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Session Attendance
timeFrame: 16 weeks
Secondary outcomes:
measure: PTSD Checklist for DSM-5 (PCL-5)
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Decatur
country: United States
facility: Atlanta VA Medical and Rehab Center, Decatur, GA
state: Georgia
city: Ann Arbor
country: United States
facility: VA Ann Arbor Healthcare System, Ann Arbor, MI
state: Michigan
city: Minneapolis
country: United States
facility: Minneapolis VA Health Care System, Minneapolis, MN
state: Minnesota
Study officials:
affiliation: Minneapolis VA Health Care System, Minneapolis, MN
name: Laura A. Meis, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.