Primary Care-Based Mindfulness Intervention for Veterans With PTSD

PTSD Clinical Trial

Official title:

Primary Care-Based Mindfulness Intervention for Veterans With PTSD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02399696
• Other study ID #: 540
• Status: Completed
• Phase: N/A
• First received: March 23, 2015
• Last updated: March 26, 2015
• Start date: March 2013
• Est. completion date: June 2014

Study information

• Verified date: March 2015
• Source: Syracuse VA Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

1) 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• PTSD

Intervention

Behavioral:
• Primary Care-Brief Mindfulness Program
A 4-week group program adapted from the 8-week Mindfulness Based Stress Reduction (MBSR) curriculum
• Primary Care-Treatment as Usual
Typical VA primary care treatment, including mental health services delivered by primary care staff.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Syracuse VA Medical Center	Syracuse University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PTSD symptoms as measured by the PTSD Checklist		8 weeks	No
Secondary	Depression symptoms as measured by the Patient Health Questionaire-9		8 weeks	No