Mindfulness and Present Centered Therapies for PTSD: Efficacy and Mechanisms

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by University of Michigan.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Michigan
ClinicalTrials.gov Identifier:
NCT01347749
First received: April 27, 2011
Last updated: May 3, 2011
Last verified: April 2011
  Purpose

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.


Condition Intervention
Posttraumatic Stress Disorder
Behavioral: Mindfulness & Compassion Meditation-based Exposure Therapy
Behavioral: Present Centered Therapy for PTSD

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mindfulness and Self-Compassion Meditation for Combat Posttraumatic Stress Disorder: Randomized Controlled Trial and Mechanistic Study

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Clinician Administered PTSD Scale [ Time Frame: pre-therapy, and post-therapy (week 16) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • PTSD Checklist (PCL-C) [ Time Frame: pre-therapy, and post-therapy (week 16) ] [ Designated as safety issue: No ]
    is a 17-item self-report assessment of PTSD severity using a 5-point scale, from 1 (not at all) to 5 (very often). It has good reliability and validity.

  • Posttraumatic Cognitions Inventory (PTCI) [ Time Frame: pre-therapy, and post-therapy (week 16) ] [ Designated as safety issue: No ]
    PTCI is a 36-item assessment of negative thoughts about the self, negative thoughts about the world, and self-blame. It has good psychometrics and has been related to change in PTSD symptoms with treatment


Estimated Enrollment: 80
Study Start Date: March 2011
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Meditation intervention for PTSD
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
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.
Other Name: Mindfulness-based Exposure therpay
Active Comparator: Active Control Psychotherapy
This is a more standard from of group psychotherapy (talk therapy) which focusses on current symptoms and stressors
Behavioral: Present Centered Therapy for PTSD
This 16 week, active group psychotherapy involves PTSD psychoeducation, supportive listening, and focusses on current stressors and PTSD symptoms.
Other Name: Present Centered Group Therapy

  Hide Detailed Description

Detailed Description:

Background: "Mindfulness meditation" is an ancient "Mind-Body" attentional technique for cultivating present-focused, non-judgmental attention to sensory, interoceptive, emotional, and cognitive processes. It is proposed to lead to a greater sense of well-being and acceptance, greater cognitive flexibility, and better tolerance of painful and distressing physical, emotional, and cognitive phenomena. Our group has found a model of emotional meta-awareness leads to decreased amygdala and increased medial prefrontal cortex (mPFC) activation. Mindfulness meditation has also been suggested to work by volitionally altering self-related cognitive/emotional processing to shift away from the predominate 'narrative' (and potentially ruminative) mode to a more 'experiential', present-centered mode in which arising sensations, percepts, emotions, and cognitions can be perceived with greater equanimity and flexibility. Mindfulness-based Stress Reduction (MBSR) is helpful for coping with chronic pain, fibromyalgia, and distress and anxiety associated with major medical disorders, and Mindfulness-based Cognitive Therapy (MBCT) for preventing depression relapse in patients. "Compassion meditation" is likewise an ancient practice for cultivating and stabilizing a sense of pro-social, empathic, kind/loving and compassionate regard to one's self and others, and in the Tibetan tradition, is based upon a 'foundation' of mindfulness. A single small trial found a loving-kindness meditation improved chronic lower back pain symptoms, and neuroimaging studies have found effects on emotional neurocircuitry.

Objective/Hypothesis: We hypothesize that practice of mindfulness and Tibetan self-compassion meditation by PTSD patients will lead to 1.) improvement in PTSD and other symptoms and quality of life 2.) improved emotional regulation, attentional control, increased 'mindfulness' and self-compassion, and 3.) strengthening of mPFC circuits during emotional provocation. There are theoretical considerations and limited empirical data that mindfulness and Tibetan compassion meditation may be useful for combat-related PTSD, which is marked by exaggerated emotional responses and distress to trauma memories and cues, distressing guilt and self-blame, and emotional dysregulation; however, the acceptability and efficacy of mindfulness and Tibetan compassion meditation not been demonstrated in combat PTSD. A pilot study at the Ann Arbor VA PTSD Clinic adapted a psychotherapy using mindfulness meditation, mindful stretching exercises, and Tibetan compassion meditation for use in combat PTSD, and found significant reductions in 'avoidant' PTSD symptoms and self-blame cognitions compared to a treatment-as-usual group. Importantly, we were also able to identify some obstacles to acceptability that have provided our group with greater insight and experience into how to acceptably and effectively deliver meditation programs to combat veterans seeking treatment for PTSD. PTSD neuroimaging studies implicate deficits during emotional provocation in medial prefrontal cortex (mPFC), associated with emotional regulation.

Specific Aims:

Aim 1. Further develop a manualized group psychotherapy based on mindfulness and Tibetan self-compassion meditation for combat PTSD.

Aim 2. Formally test our meditation intervention for PTSD in a randomized controlled trial.

Aim 3. Utilizing a 'translational design', perform a pilot study of fMRI neuroimaging to determine the effects of meditation on neurocircuitry underlying emotional regulation that may mediate therapeutic effects

Study Design: We will develop a manual for our meditation incorporating input from qualitative data from patients and an expert advisory board including meditation and PTSD therapy experts. We will adapt a present-centered therapy group as a control intervention, controlling for hours of therapist contact. We will randomly assign PTSD patients to either meditation or present-cetnered therapy, with pre- post, 3 mo, and 6 mo follow-up assessments with validated measures of PTSD and psychiatric symptoms, quality of life, "mindfulness", emotional regulation, and trauma-related maladaptive cognitions. We will also perform a pilot study of fMRI neuroimaging to determine the effects of meditation on neurocircuitry underlying emotional regulation that may mediate therapeutic effects. Validated emotional and social cognition neuroimaging paradigms will be used to examine specific effects of mindfulness meditation on mPFC and cortico-limbic neurocircuitry.

Impact: This research will examine the efficacy of a highly novel treatment approach for PTSD, and also specific neural mechanisms of emotional regulation and how they may be altered by effortful rehearsal of alternate emotion regulation and emotion induction techniques. It may thus lead to improved treatment and understanding of therapeutic mechanisms involving emotional regulation.

  Eligibility

Ages Eligible for Study:   21 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Suicidality Substance dependence not in treatment Personality disorder taking medications that interfere with stress hormone measures
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01347749

Locations
United States, Michigan
VA Ann Arbor Healthcare System Recruiting
Ann Arbor, Michigan, United States, 48105
Contact: Birgit Roller, MA    734-845-5480    birgitr@med.umich.edu   
Contact: Anthony P King, PhD    734 845-3905    samadhi@med.umich.edu   
Principal Investigator: Israel Liberzon, MD         
Sub-Investigator: Nicholas Giardino, PhD         
Sub-Investigator: Sheila AM Rauch, PhD         
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Anthony King, PhD    734-936-3533    samadhi@med.umich.edu   
Contact: Birgit Roller, MA    734 845 5480    birgitr@med.umich.edu   
Principal Investigator: Anthony P King, PhD         
Principal Investigator: Israel Liberzon, MD         
Sponsors and Collaborators
University of Michigan
  More Information

No publications provided

Responsible Party: Israel Liberzon, MD and Anthony King, PhD co-PIs, University of Michigan
ClinicalTrials.gov Identifier: NCT01347749     History of Changes
Other Study ID Numbers: W81XWH-08-2-0208
Study First Received: April 27, 2011
Last Updated: May 3, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
Meditation
Mindfulness
Compassion
Group Psychotherapy
Emotional Regulation
fMRI

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 20, 2014