Primary Care Brief Mindfulness Training for Veterans With PTSD

Post-traumatic Stress Disorder Clinical Trial

Official title:

Primary Care Brief Mindfulness Training for Veterans With PTSD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03352011
• Other study ID #: 1147099-1
• Secondary ID: 5R34AT009678-02
• Status: Completed
• Phase: N/A
• Start date: January 2, 2018
• Est. completion date: June 17, 2020

Study information

• Verified date: November 2022
• Source: Syracuse VA Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: June 17, 2020
• Est. primary completion date: February 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• 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.
• 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."

Locations

Country	Name	City	State
United States	Syracuse Veterans Affairs Medical Center	Syracuse	New York

Sponsors (3)

Lead Sponsor	Collaborator
Syracuse VA Medical Center	National Center for Complementary and Integrative Health (NCCIH), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Assessment Retention Assessment Retention	rate of participants who complete all assessment time points	enrollment to 24 week follow-up
Primary	Intervention Retention	rate of participants who complete assigned intervention	enrollment to 24 week follow-up
Primary	Primary Care Brief Mindfulness Fidelity Assessment	Number of essential components of the Primary Care Brief Mindfulness Training curriculum delivered across all 5 cohorts of PCBMT. Number of essential components 0-90. Higher scores indicate more components delivered and better fidelity.	enrollment to 8 week follow-up
Primary	Client Satisfaction Scale	measured by the Client Satisfaction Questionnaire, scale range 1-32 with 32 indicating highest satisfaction.	8 week follow-up
Secondary	Post-traumatic Stress Checklist for DSM-5	PTSD Checklist-5. Scale range 0-63 with 63 indicating highest PTSD severity.	24 week follow-up
Secondary	Recovery Orientation Scale- 24	Recovery Orientation Scale-24 measuring recovery from mental health concerns. Range 24-120, with 120 indicating the greatest amount of recovery.	24 week follow-up
Secondary	Patient Health Questionnaire-9,	Patient Health Questionnaire-9, range 0-27, with 27 indicating the greatest amount of depression.	24 week follow-up
Secondary	Self Compassion Scale- Short Form	Self Compassion Scale- Short Form, range 0-60, with 60 indicating the greatest amount of self compassion.	8 week post-treatment
Secondary	Health Promoting Lifestyle Profile II: Health Responsibility Subscale	Health Promoting Lifestyle Profile II: Health Responsibility. Subscale ranges from 9-36, with 36 indicating the most health responsibility.	24 week follow-up