Clinical trial NCT03352011: Primary Care Brief Mindfulness Training for Veterans With PTSD
Official title: Primary Care Brief Mindfulness Training for Veterans With PTSD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-traumatic Stress Disorder
Lead sponsor: Syracuse VA Medical Center
Sponsor class: FED
Collaborators: name: National Institutes of Health (NIH)
name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2017-11-24
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Number of Participants With Assessment Retention Assessment Retention
timeFrame: enrollment to 24 week follow-up
measure: Intervention Retention
timeFrame: enrollment to 24 week follow-up
measure: Primary Care Brief Mindfulness Fidelity Assessment
timeFrame: enrollment to 8 week follow-up
measure: Client Satisfaction Scale
timeFrame: 8 week follow-up
Secondary outcomes:
measure: Post-traumatic Stress Checklist for DSM-5
timeFrame: 24 week follow-up
measure: Recovery Orientation Scale- 24
timeFrame: 24 week follow-up
measure: Patient Health Questionnaire-9,
timeFrame: 24 week follow-up
measure: Self Compassion Scale- Short Form
timeFrame: 8 week post-treatment
measure: Health Promoting Lifestyle Profile II: Health Responsibility Subscale
timeFrame: 24 week follow-up
Other outcomes:
Locations:
city: Syracuse
country: United States
facility: Syracuse Veterans Affairs Medical Center
state: New York
Study officials:
affiliation: VA Center for Intergrated Healthcare
name: Kyle Possemato, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: