Primary Care-Based Mindfulness Intervention for Veterans With PTSD

NCT02399696 | Completed

• 1 other identifier: 540
• Study Type: interventional
• Target: 62
• Locations: 0 countries
• Sites: N/A

Brief Summary

Primary care patients typically do not receive adequate PTSD treatment because of their reluctance to engage in empirically-supported treatments offered in specialty care settings. Effective treatments for PTSD are also typically not provided in primary care. Brief skill-based treatments offered in primary care may alleviate symptoms and prepare patients to engage in additional treatment. VA primary care patients with PTSD (N=62) were recruited for a randomized clinical trial comparing a Primary Care-Brief Mindfulness Program (PC-bMP) to primary care-treatment as usual (PC-TAU). PC-bMP is a 4-week group program adapted from the 8-week Mindfulness Based Stress Reduction (MBSR) curriculum. Veterans in the PC-bMP condition demonstrated significantly greater decreases in PTSD and depressive symptoms from pre-treatment to post-treatment compared to PC-TAU. These gains were maintained at 8 and 12 week follow-up. PC-bMP participants experienced clinically significant decreases in PTSD, averaging a 15-point drop on the Clinician-Administered PTSD Scale. Exploratory analyses revealed that the describing, non-judging, and acting with awareness facets of mindfulness may account for decreases in PTSD. Our data support preliminary efficacy of a brief mindfulness-based intervention for Veterans with PTSD in primary care. Further research is needed to investigate how PC-bMP may facilitate engagement into full length empirically-supported treatment for PTSD.

Conditions

PTSD

Outcome Measures

Primary Outcomes (1)

• PTSD symptoms as measured by the PTSD Checklist

  8 weeks

Secondary Outcomes (1)

• Depression symptoms as measured by the Patient Health Questionaire-9

  8 weeks

Study Arms (2)

Primary Care-Brief Mindfulness Program

EXPERIMENTAL

A 4-week group program adapted from the 8-week Mindfulness Based Stress Reduction (MBSR) curriculum.

Behavioral: Primary Care-Brief Mindfulness Program

Primary Care-Treatment as Usual

ACTIVE COMPARATOR

Typical VA primary care treatment, including mental health services delivered by primary care staff.

Behavioral: Primary Care-Treatment as Usual

Interventions

Primary Care-Brief Mindfulness Program BEHAVIORAL

A 4-week group program adapted from the 8-week Mindfulness Based Stress Reduction (MBSR) curriculum

Primary Care-Brief Mindfulness Program

Primary Care-Treatment as Usual BEHAVIORAL

Typical VA primary care treatment, including mental health services delivered by primary care staff.

Primary Care-Treatment as Usual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) sub-threshold or diagnostic level PTSD related to military service as determined by the Clinician Administered PTSD Scale

You may not qualify if:

• \) gross cognitive impairment, 2) moderate to severe traumatic brain injury, 3) suicide attempt or intent to commit suicide in the last two months, and 4) receipt of mental healthcare (psychotherapy or medication) outside VA primary in the last two months.

Sponsors & Collaborators

• Syracuse VA Medical Center: lead
• Syracuse University: collaborator

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

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

Study Officials

• Kyle Possemato, Ph.D.

  Syracuse VAMC

  PRINCIPAL INVESTIGATOR

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: Clinical Research Psychologists

Study Record Dates

• First Submitted: March 23, 2015
• First Posted: March 26, 2015
• Study Start: March 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: March 31, 2015

Record last verified: 2015-03