Portable Mantram Meditation for Veterans With Military Related Post Traumatic Stress Syndrome (PTSD)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01506323
First received: December 19, 2011
Last updated: June 30, 2014
Last verified: June 2014
  Purpose

The aim of this study is to determine the usefulness of a portable, meditation-based intervention called the Mantram Repetition Program (MRP) for Veterans with military-related posttraumatic stress disorder (PTSD). This study will compare the individual delivery of the MRP to Present-Centered Individual Therapy (PCIT) at two sites in San Diego, CA and Bedford, MA.


Condition Intervention Phase
Veterans With Posttraumatic Stress Disorder (PTSD)
Stress Disorders, Post-Traumatic
Behavioral: Mantram Repetition Program (MRP)
Behavioral: Present Centered Individual Therapy (PCIT)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Portable Mantram Meditation for Veterans With Military Related PTSD

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Clinician-Administered PTSD Scale (CAPS) [ Time Frame: Baseline to Post-treatment (8 weeks) and to 16 week follow-up ] [ Designated as safety issue: No ]
    PTSD symptom severity is measured by CAPS to determine PTSD diagnosis. The scale rates 17 items representing the Diagnostic and Statistical Manual IV (DSM-IV) criteria B (re-experiencing), C (avoidance/numbing) and D (hyper-arousal). CAPS has demonstrated high levels of internal consistency, good inter-rater reliability, & excellent convergent validity. The F1/I2 rule will be applied to establish the diagnosis of PTSD aligned with DSM-IV (e.g. one symptom of Criterion B, three of Criterion C, and two of Criterion D. The CAPS also includes an item to assess duration of PTSD symptoms.


Secondary Outcome Measures:
  • PTSD Checklist - Military [ Time Frame: Baseline to Post-treatment (8 weeks) and to 16 week follow-up ] [ Designated as safety issue: No ]
    PCL-M is a brief self-report screening instrument for PTSD symptoms related to military trauma. Seventeen items are scored on a 1 (not at all bothersome) to 5 (extremely bothersome) Likert scale. Higher scores indicate greater symptom bothersomeness.

  • Functional Assessment of Chronic Illness Therapy-Spiritual Wellbeing Scale (FACIT-SWB) [ Time Frame: Baseline to Post-treatment (8 weeks) and to 16 week follow-up ] [ Designated as safety issue: No ]
    The FACIT-SWB was developed to assess spiritual components (e.g., harmony, meaning, purpose in life, peacefulness, faith/assurance) of quality of life using 23 items rated on a 5-point Likert scale. Higher scores indicating greater spiritual well-being. Validity has been demonstrated by significant Pearson correlations between measures of quality of life, mood, and religious growth. It has demonstrated internal consistency reliability.

  • Five Facet Mindfulness Questionnaire (FFMQ) [ Time Frame: Post-treatment and 8 week follow-up ] [ Designated as safety issue: No ]
    FFMQ a 39-item scale that measures five components of mindfulness: observing; describing; acting with awareness; non-judging of inner experience; and non-reactivity to inner experience. FFMQ scores have mediated the effect of mindfulness training on positive changes in psychological state.

  • Insomnia Severity Index (ISI) [ Time Frame: Baseline to Post-treatment (8 weeks) and to 16 week follow-up ] [ Designated as safety issue: No ]
    ISI is a widely used measure of insomnia with well-established reliability and validity. It consists of seven items, three of which assess severity of insomnia (i.e., degree of difficulty falling asleep, staying asleep, and waking too early). The remaining questions tap satisfaction with sleep pattern, effect of sleep on daytime and social functioning, and concern about current sleep difficulties. Both categorical and continuous measures of sleep difficulties can be assessed. Items are rated on a 0-4 Likert scale. Total scores range from 0-28 and results are interpreted as 0-7 = no clinically significant insomnia, 8-14 = sub-threshold insomnia, 15-21 = moderately severe clinical insomnia (moderate severity) and 21-28 = severe clinical insomnia.

  • Veterans RAND SF-12 (VRSF-12) Mental Health Function [ Time Frame: Baseline to Post-Treatment (Week 16) ] [ Designated as safety issue: No ]
    VRSF-12 is a brief version of the SF-36, assessing two broad domains of physical and mental health status (Physical Component Score, PCS and Mental Component Score, MCS). These instruments were adapted for use in the VHA by increasing the number of response options resulting in fewer floor and ceiling effects, increased reliability, and greater explanatory power over the original versions of the instrument. They are among the most widely used functional status measures in the world and have been shown to be highly reliable and valid. Reliability estimates for the PCS-12=.80 and for the MCS-12=.76.

  • Posttraumatic Growth Inventory (PTGI) [ Time Frame: Baseline to Post-treatment (8 weeks) and to 16 week follow-up ] [ Designated as safety issue: No ]
    The PTGI is a 21-item, 6-point Likert scale self-report measure (0 = �I did not experience this change as a result of my crisis� to 5 = �I experienced this change to a very great degree as a result of my crisis�). There are five domains of growth: I. Relating to Others; II. New Possibilities; III. Personal Strength; IV. Spiritual Change; and V. Appreciation of Life. Higher scores are indicative of greater growth.


Enrollment: 189
Study Start Date: January 2012
Estimated Study Completion Date: September 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
A portable meditation-based "Mantram Repetition Program (MRP)" will be delivered individually in 8-weekly 1 hour sessions to teach a set of strategies for training attention to manage symptoms. For this study, the program targets symptoms of posttraumatic stress disorder (PTSD) in Veterans who have experienced military-related trauma.
Behavioral: Mantram Repetition Program (MRP)
The MRP includes three strategies for training attention and managing symptoms: Mantram Repetition, Slowing Down and One-Pointed Attention. In this study, it is delivered individually in 8 weekly 1 hour sessions that consist of information, experiential learning and homework. A "mantram" is a self-selected, sacred word or phrase that is meaningful to the participant. Slowing down refers to setting priorities and doing things carefully so one is not rushed or does not make mistakes. One-pointed attention refers to concentrating on one thing at a time (similar to mindfulness). These three tools are presented to work together synergistically and cumulatively to interrupt negative thoughts and emotional states such as anger, rage, irritability and hyper-arousal. The unique focus on spiritual words is linked to what one might call inner spiritual resources.
Other Name: MRP
Active Comparator: Arm 2
Present Centered Individual Therapy (PCIT) is a form of individually delivered 8 weekly, 1 hour sessions that are problem-oriented to improve current coping. For this study, it serves as an attention control arm for the non-specific effects of individual therapist interaction.
Behavioral: Present Centered Individual Therapy (PCIT)
The PCIT is a form of individual therapy that is problem-oriented to improve current coping. It typically avoids actual details of traumatic experiences. In this study, it is delivered individually in 8 weekly, 1 hour sessions to serve as an active, attention comparison arm. Sessions are unstructured and managed so that there is some engagement of the participant's emotional concerns with an emphasis on strengths and process encouragement rather than skills training.
Other Name: PCIT

Detailed Description:

The investigators aim to conduct a rigorous test of the therapeutic treatment efficacy of the Mantram Repetition Program (MRP) by offering it as a stand-alone intervention, compared to an attention control arm, in a more diverse sample of Veterans with post-traumatic stress disorder (PTSD) who will be recruited from a variety of clinics, including primary care, women's health and specialty clinics in two geographical locations. A prospective, randomized, two-site clinical trial will be conducted to compare the effect of the MRP to that of Present Centered Individual Therapy on scores of the Clinician Administered PTSD Scale (CAPS) and PTSD Checklist-Military (PCL-M) at three time-points (pre-treatment, post-treatment at 8 weeks and at follow-up or 16 weeks). The investigators propose to address the following aims: To examine the MRP as a stand-alone intervention for efficacy in treating Veterans with PTSD; To examine MRP as stand-alone intervention for efficacy in treating trauma-related psychological distress (depression, insomnia, anger) in Veterans with PTSD; To examine MRP as a stand-alone intervention for efficacy in improving mental health, quality of life, spiritual well-being, mindfulness and posttraumatic growth.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years of age or older
  • Read and write English fluently
  • Traumatic event related to military-duty, including combat, military training accidents, and military sexual trauma
  • Transportation to attend meetings and available to complete study protocols
  • Stable dose and type of PTSD medications for at least 6 weeks (per chart review)
  • Willing to track medication changes during study

Exclusion Criteria:

  • Inability to give informed, voluntary consent
  • Cognitive impairment sufficient to cause inability to complete the protocol
  • Psychotic symptoms
  • Dementia or other organic mental disorders that may cause inability to complete the protocol
  • Significant documented alcohol/substance abuse
  • Presence of severe suicidal urges or intent
  • Residence in a geographical area outside of San Diego County or Bedford, MA area
  • Current daily practice of any skills of any meditation-based program - including, but not limited to:

    • Transcendental Meditation (TM)
    • yoga
    • Tai Chi
    • Qi-Gong
    • Vipassana
    • Loving-Kindness Meditation
    • Mindfulness-Based Stress Reduction
    • or other mindfulness intervention
    • guided imagery
    • mantram repetition
    • passage meditation
    • walking meditation
    • Zen or Buddhist meditation
    • self-hypnosis, bio-feedback, etc.
  • Other participant circumstances that, in the opinion of a consensus of study team, would interfere with the safety of a prospective participant or their need for treatment.
  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: NCT01506323

Locations
United States, California
VA San Diego Healthcare System
San Diego, California, United States, 92161
United States, Massachusetts
Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
Bedford, Massachusetts, United States, 01730
Sponsors and Collaborators
Investigators
Principal Investigator: Jill E. Bormann, PhD RN San Diego Veterans Healthcare System
Principal Investigator: Anashua Rani Elwy, PhD MSc BA Edith Nourse Rogers Memorial Veterans Hospital
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01506323     History of Changes
Other Study ID Numbers: SPLE-003-11S
Study First Received: December 19, 2011
Last Updated: June 30, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Mind-Body Therapies
Stress Disorders, Post-Traumatic
Veterans Health
Clinical Trials, Randomized
Quality of life
Spirituality
Meditation

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

ClinicalTrials.gov processed this record on July 22, 2014