Mindfulness and Present Centered Therapies for PTSD: Efficacy and Mechanisms

NCT01347749 | Completed

• 1 other identifier: W81XWH-08-2-0208
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 2

Brief Summary

This project will study whether a new therapy that includes the practice of forms of meditation is helpful for combat veterans returning from deployments in Iraq or Afghanistan suffering with posttraumatic stress disorder (PTSD). "Mindfulness meditation" cultivates present-focused, non-judgmental attention to ones body, emotions, and thoughts, and is proposed to lead to a greater sense of well-being and acceptance and better tolerance of painful and distressing emotions. "Compassion" and "loving-kindness" meditations help stabilize positive emotions like love and compassion, and may also be helpful for chronic pain, and possibly depression and PTSD. This study will compare a 16 week psychotherapy group for PTSD involving Mindfulness and Self-compassion meditation, with a more standard form of group psychotherapy known as "Present-centered group therapy". Both therapies will be conducted at the VA Ann Arbor PTSD clinic by VA psychotherapists. (The study is also approved by the IRB of the VA Ann Arbor). Combat veterans will be randomly assigned to either the Meditation or the standard group psychotherapy. All patients will also receive fMRI brain scans before and after the therapy, as well as assessment interviews before, at 8 weeks, and immediately post-therapy, and at 3 mo and 6 mo follow-ups. Saliva cortisol and measures of attention will also be obtained at each assessment.

Conditions

Posttraumatic Stress Disorder

Keywords

Meditation; Mindfulness; Compassion; Group Psychotherapy; Emotional Regulation; fMRI

Outcome Measures

Primary Outcomes (1)

• Clinician Administered PTSD Scale

  is an interview measure of PTSD severity and the primary outcome measure for the study. Current PTSD will be assessed in relation to the OEF/OIF war-zone trauma that is currently most upsetting. The CAPS has excellent psychometrics. Completion requires about 45 minutes.

  pre-therapy, and post-therapy (week 16)

Secondary Outcomes (2)

• PTSD Checklist (PCL-C)

  pre-therapy, and post-therapy (week 16)

• Posttraumatic Cognitions Inventory (PTCI)

  pre-therapy, and post-therapy (week 16)

Study Arms (2)

Mindfulness & Compassion Meditation-based Exposure Therapy

EXPERIMENTAL

A 16 week group psychotherapy intervention involving PTSD psychoeducation, breathing exercises and relaxation, and Mindfulness and Self-compassion meditation exercises in session and daily at home, and Mindfulness-based in vivo exposure exercises.

Behavioral: Mindfulness & Compassion Meditation-based Exposure Therapy

Present Centered Therapy for PTSD

ACTIVE COMPARATOR

This is a more standard from of group psychotherapy (talk therapy) which focusses on current symptoms and stressors

Behavioral: Present Centered Therapy for PTSD

Interventions

Mindfulness & Compassion Meditation-based Exposure Therapy BEHAVIORAL

A 16 week group psychotherapy intervention involving PTSD psychoeducation, breathing exercises and relaxation, and Mindfulness and Self-compassion meditation exercises in session and daily at home, and Mindfulness-based in vivo exposure exercises.

Also known as: Mindfulness-based Exposure therapy

Mindfulness & Compassion Meditation-based Exposure Therapy

Present Centered Therapy for PTSD BEHAVIORAL

This 16 week, active group psychotherapy involves PTSD psychoeducation, supportive listening, and focusses on current stressors and PTSD symptoms.

Also known as: Present Centered Group Therapy

Present Centered Therapy for PTSD

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Combat veteran serving in Iraq or Afghanistan Has PTSD (CAPS score \> 40)

You may not qualify if:

• Suicidality Substance dependence not in treatment Personality disorder taking medications that interfere with stress hormone measures

Sponsors & Collaborators

• University of Michigan: lead
• VA Ann Arbor Healthcare System: collaborator

Study Sites (2)

VA Ann Arbor Healthcare System

Ann Arbor, Michigan, 48105, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Emotional Regulation

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Self-Control; Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Study Record Dates

• First Submitted: April 27, 2011
• First Posted: May 4, 2011
• Study Start: March 1, 2011
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: November 6, 2019

Record last verified: 2019-11

Locations

US (2)