Mindfulness and Present Centered Therapies for PTSD: Efficacy and Mechanisms
Condition: Posttraumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

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.
    

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.
    

Intervention name(s): Mindfulness & Compassion Meditation-based Exposure Therapy; Present Centered Therapy for PTSD
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; This 16 week, active group psychotherapy involves PTSD psychoeducation, supportive listening, and focusses on current stressors and PTSD symptoms.
Other intervention name(s): Mindfulness-based Exposure therapy; Present Centered Group Therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Meditation; Mindfulness; Compassion; Group Psychotherapy; Emotional Regulation; fMRI