Primary Care Brief Mindfulness Training for Veterans With PTSD

NCT03352011 | Completed Results DMC

• 2 other identifiers: 1147099-15R34AT009678-02
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-traumatic Stress Disorder

Outcome Measures

Primary Outcomes (4)

• Number of Participants With Assessment Retention Assessment Retention

  rate of participants who complete all assessment time points

  enrollment to 24 week follow-up

• Intervention Retention

  rate of participants who complete assigned intervention

  enrollment to 24 week follow-up

• 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

• Client Satisfaction Scale

  measured by the Client Satisfaction Questionnaire, scale range 1-32 with 32 indicating highest satisfaction.

  8 week follow-up

Secondary Outcomes (5)

• Post-traumatic Stress Checklist for DSM-5

  24 week follow-up

• Recovery Orientation Scale- 24

  24 week follow-up

• Patient Health Questionnaire-9,

  24 week follow-up

• Self Compassion Scale- Short Form

  8 week post-treatment

• Health Promoting Lifestyle Profile II: Health Responsibility Subscale

  24 week follow-up

Study Arms (2)

Primary Care Brief Mindfulness Training

EXPERIMENTAL

group-based mindfulness training

Behavioral: Primary Care Brief Mindfulness Training

PTSD Psychoeducational Class

ACTIVE COMPARATOR

group-based psychoeducation class

Behavioral: PTSD Psychoeducational Class

Interventions

Primary Care Brief Mindfulness Training 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.

Primary Care Brief Mindfulness Training

PTSD Psychoeducational Class 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."

PTSD Psychoeducational Class

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• enrolled in services at the Syracuse or Canandaigua VAMC and
• report significant PTSD symptoms (qualifying criterion A traumatic event plus at least a 31 on the PCL-5).

You may not qualify if:

• gross cognitive impairment (\>16 on the Blessed OMC),
• suicide attempt or desire to commit suicide in the last month (as measured by P4 screener).
• have received psychotherapy or change in psychiatric medication outside of VHA primary care in the last 2 months.
• voice a preference to be directly referred to specialty mental health care.

Sponsors & Collaborators

• Syracuse VA Medical Center: lead
• National Institutes of Health (NIH): collaborator
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Syracuse Veterans Affairs Medical Center

Syracuse, New York, 13210, United States

Location

Related Publications (1)

• 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.

  PMID: 36576365 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Kyle Possemato
• Organization: VA Center for Integrated Heathcare

kyle.possemato@va.gov

315-425-4400

Study Officials

• Kyle Possemato, Ph.D.

  VA Center for Intergrated Healthcare

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Director for Research, Center for Integrated Healthcare

Study Record Dates

• First Submitted: November 14, 2017
• First Posted: November 24, 2017
• Study Start: January 2, 2018
• Primary Completion: February 10, 2020
• Study Completion: June 17, 2020
• Last Updated: December 22, 2022
• Results First Posted: December 22, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)