Posttraumatic Stress DisorderNCT01347749
Mindfulness and Present Centered Therapies for PTSD: Efficacy and Mechanisms
A study testing Mindfulness & Compassion Meditation-based Exposure Therapy and Present Centered Therapy for PTSD in people with Posttraumatic Stress Disorder, run by University of Michigan at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 21 to 50 years, men only
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- Mindfulness & Compassion Meditation-based Exposure Therapy and Present Centered Therapy for PTSD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2011to Nov 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Combat veteran serving in Iraq or Afghanistan Has PTSD (CAPS score > 40)
Who cannot join
- Suicidality Substance dependence not in treatment Personality disorder taking medications that interfere with stress hormone measures
Trial locations and contacts
2 sites in 1 country.
United States2 sites
VA Ann Arbor Healthcare System
Ann Arbor, Michigan, 48105
University of Michigan
Ann Arbor, Michigan, 48109
About this study
Official title: Mindfulness and Self-Compassion Meditation for Combat Posttraumatic Stress Disorder: Randomized Controlled Trial and Mechanistic Study
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.
Read the 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.
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- Mindfulness & Compassion Meditation-based Exposure Therapy, Present Centered Therapy for PTSD
- Keywords
- Meditation, Mindfulness, Compassion, Group Psychotherapy, Emotional Regulation, fMRI
- Medical subject headings
- Stress Disorders, Post-Traumatic, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness & Compassion Meditation-based Exposure TherapyBehavioural
Also called Mindfulness-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.
Present Centered Therapy for PTSDBehavioural
Also called Present Centered Group Therapy
This 16 week, active group psychotherapy involves PTSD psychoeducation, supportive listening, and focusses on current stressors and PTSD symptoms.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Behavioral: Present Centered Therapy for PTSD |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: pre-therapy, and post-therapy (week 16)
Secondary outcomes (2)
PTSD Checklist (PCL-C)
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.
Measured: pre-therapy, and post-therapy (week 16)
Posttraumatic Cognitions Inventory (PTCI)
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
Measured: pre-therapy, and post-therapy (week 16)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2011 (estimated)
- Study startMar 2011
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- VA Ann Arbor Healthcare System
- Responsible party
- Principal investigator, Anthony King, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01347749
- Sponsor's protocol ID
- W81XWH-08-2-0208
- Status last verified
- Nov 2019
- First submitted
- 27 Apr 2011
- Last updated
- 6 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness and Self-Compassion Meditation for Combat Posttraumatic Stress Disorder: Randomized Controlled Trial and Mechanistic Study
- ClinicalTrials.gov ID
- NCT01347749
- Acronym / sponsor ID
- W81XWH-08-2-0208
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- Meditation, Mindfulness, Compassion, Group Psychotherapy, Emotional Regulation, fMRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- VA Ann Arbor Healthcare System
- Study start
- Mar 2011
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 4 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness & Compassion Meditation-based Exposure Therapy | Experimental | Behavioral: Mindfulness & Compassion Meditation-based Exposure TherapyA 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. |
| Present Centered Therapy for PTSD | Active comparator | Behavioral: Present Centered Therapy for PTSDThis is a more standard from of group psychotherapy (talk therapy) which focusses on current symptoms and stressors |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Combat veteran serving in Iraq or Afghanistan Has PTSD (CAPS score > 40)
Key exclusion criteria (1 listed)
- Suicidality Substance dependence not in treatment Personality disorder taking medications that interfere with stress hormone measures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness & Compassion Meditation-based Exposure TherapyAlso: Mindfulness-based Exposure therapyA 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. | Behavioural | Mindfulness & Compassion Meditation-based Exposure Therapy |
| Present Centered Therapy for PTSDAlso: Present Centered Group TherapyThis 16 week, active group psychotherapy involves PTSD psychoeducation, supportive listening, and focusses on current stressors and PTSD symptoms. | Behavioural | Present Centered Therapy for PTSD |
Primary outcome
Clinician Administered PTSD Scale
Time frame: pre-therapy, and post-therapy (week 16)
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.
2 secondary outcomes
PTSD Checklist (PCL-C)
Time frame: pre-therapy, and post-therapy (week 16)
Posttraumatic Cognitions Inventory (PTCI)
Time frame: pre-therapy, and post-therapy (week 16)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness & Compassion Meditation-based Exposure Therapy and Present Centered Therapy for PTSD in people with Posttraumatic Stress Disorder, run by University of Michigan at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinician Administered PTSD Scale (time frame: pre-therapy, and post-therapy (week 16)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2019.