Primary Care Brief Mindfulness Training for Veterans With PTSD

NCT ID: NCT03352011

Last Updated: 2022-12-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-02
• Study Completion Date: 2020-06-17

Brief Summary

The proposed study supports a line of research that seeks to improve the health of military veterans with post-traumatic stress disorder (PTSD) by teaching them mindfulness skills. The proposed study first gathers Veteran's Affairs mental health provider and peer support specialist feedback to adapt a brief mindfulness intervention and then investigates the feasibility of testing this intervention in a small randomized clinical trial. The study targets primary care patients with PTSD who may be reluctant to engage in other mental health treatments and provides them with mindfulness training to reduce PTSD symptoms, improve psychosocial functioning and increase hope for recovery.

Detailed Description

Posttraumatic Stress Disorder (PTSD) is highly prevalent in Veterans Affairs (VA) primary care patients (~11.5%) and is associated with significant functional impairment, compromised health, and economic costs. While effective psychotherapies for PTSD are available in VA specialty mental health care settings, primary care patients do not routinely engage in or complete these specialty services. Therefore, alternative delivery models are needed. This proposal integrates two lines of research: mindfulness training and peer support services to test a low-stigma intervention in primary care: Primary Care Based Mindfulness Training (PCBMT). Brief mindfulness training focuses on skill acquisition to help patients manage distress and can serve as a gateway to more intensive treatments for Veterans who are not yet willing to discuss their trauma histories. Peer support specialists help shift treatment away from the medical model focused on symptom reduction to a recovery model focused on leading a meaningful, purposeful life, with or without ongoing illness.

This proposal aims to refine our existing PCBMT to be co-delivered by VA mental health providers and peers and then test important aspects of feasibility to prepare for a future full-scale pragmatic clinical trial. First, VA providers and peers will participate in PCBMT led by study investigators who are certified Mindfulness Based Stress Reduction (MBSR) instructors. Next, study staff will gather feedback from the trained providers and peers for further adaptation and implementation. After this, providers and peers interested in being trained as PCBMT interventionists will be trained by study investigators. Finally, a pilot RCT will be conducted. Both treatments conditions will consist of four, 90-minute group sessions co-facilitated by a VA provider and Veteran peer.

The long-term goal of this research is to improve clinical and personal recovery outcomes for Veterans with PTSD. Our immediate goals are to refine PCBMT based on Veteran, provider, and peer feedback then test the methods needed to conduct a future full-scale RCT, in accordance with the following aims:

1. Gather VA mental health provider (n=5) and peer (n=5) feedback to refine PCBMT to a) ensure successful implementation in the VA setting (including creation of a provider manual and standardized provider/peer training curriculum) and b) maximize Veteran skill development to aid in future participation of evidence-based treatment for PTSD.

2. Assess the feasibility of conducting a pilot RCT (N=60) comparing PCBMT to a PTSD psychoeducation group on a) rates of recruitment and study retention, b) participant adherence and retention in treatment, provider and peer treatment fidelity, c) participant acceptability (satisfaction, perceived helpfulness) in PCBMT and control condition, and d) measuring outcomes of interest for the future larger trial including: PTSD severity, psychosocial functioning, recovery orientation, active engagement in mental health care.

Conditions

Post-traumatic Stress Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Primary Care Brief Mindfulness Training

group-based mindfulness training

Group Type: EXPERIMENTAL

Primary Care Brief Mindfulness Training

Intervention Type: BEHAVIORAL

Primary Care Brief Mindfulness Training consists of four 90-minute group classes that teach sitting meditation, body scan, moving meditation, gentle yoga, and group discussion on topics such as non-judging, patience, trust, non-striving, acceptance, and letting go.

PTSD Psychoeducational Class

group-based psychoeducation class

Group Type: ACTIVE_COMPARATOR

PTSD Psychoeducational Class

Intervention Type: BEHAVIORAL

The PTSD Psychoeducational Class is designed to provide a supportive environment for learning about PTSD-related issues and to help Veterans determine what recovery strategies will be most helpful for them. Session themes include "Civilian Readjustment and PTSD," "Trust, Safety, and Healing" and "Treatment Strategies."

Interventions

Primary Care Brief Mindfulness Training

Primary Care Brief Mindfulness Training consists of four 90-minute group classes that teach sitting meditation, body scan, moving meditation, gentle yoga, and group discussion on topics such as non-judging, patience, trust, non-striving, acceptance, and letting go.

Intervention Type: BEHAVIORAL

PTSD Psychoeducational Class

The PTSD Psychoeducational Class is designed to provide a supportive environment for learning about PTSD-related issues and to help Veterans determine what recovery strategies will be most helpful for them. Session themes include "Civilian Readjustment and PTSD," "Trust, Safety, and Healing" and "Treatment Strategies."

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. enrolled in services at the Syracuse or Canandaigua VAMC and

2. report significant PTSD symptoms (qualifying criterion A traumatic event plus at least a 31 on the PCL-5).

Exclusion Criteria

1. gross cognitive impairment (>16 on the Blessed OMC),

2. suicide attempt or desire to commit suicide in the last month (as measured by P4 screener).

3. have received psychotherapy or change in psychiatric medication outside of VHA primary care in the last 2 months.

4. voice a preference to be directly referred to specialty mental health care.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

Syracuse VA Medical Center

FED

Sponsor Role: lead

Responsible Party

Kyle Possemato

Associate Director for Research, Center for Integrated Healthcare

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kyle Possemato, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

VA Center for Intergrated Healthcare

Locations

Syracuse Veterans Affairs Medical Center

Syracuse, New York, United States

Countries

United States

References

Possemato K, Bergen-Cico D, Buckheit K, Ramon A, McKenzie S, Smith AR, Wade M, Beehler GP, Pigeon WR. Randomized Clinical Trial of Brief Primary Care-Based Mindfulness Training Versus a Psychoeducational Group for Veterans With Posttraumatic Stress Disorder. J Clin Psychiatry. 2022 Dec 28;84(1):22m14510. doi: 10.4088/JCP.22m14510.

Reference Type: DERIVED

PMID: 36576365 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

5R34AT009678-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1147099-1

Identifier Type: -

Identifier Source: org_study_id