Mantram Repetition Meditation for Veterans With PTSD

NCT01506323 | Completed Phase 3 Results DMC

• 1 other identifier: SPLE-003-11S
• Study Type: interventional
• Target: 181
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of this study was 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 compared the individual delivery of the MRP to individual delivery of Present-Centered Therapy (PCT) at two sites in San Diego, California, and Bedford, Massachusetts.

Conditions

Stress Disorders, Post-Traumatic

Keywords

Complementary Therapy; Stress Disorders, Post-Traumatic; Veterans Health; Clinical Trials, Randomized; Mindfulness; Spirituality; Meditation; Mind-body therapy

Outcome Measures

Primary Outcomes (5)

• Clinician-Administered PTSD Scale (CAPS) Diagnostic and Statistical Manual, 4th ed., Text Revision (DSM-IV)

  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. CAPS total score ranges from 0-136 with higher scores indicating greater symptom severity.

  Baseline to post-treatment (week 8); Baseline to 2 months post-treatment.

• Re-experiencing Subscale (Criterion B) on the Clinician Administered PTSD Scale (CAPS)

  This subscale measures the frequency and intensity of (1) recurrent or intrusive recollections of trauma, (2) recurrent, distressing dreams of the trauma, (3) acting as if the traumatic event were recurring like a flashback, (4) intense psychological distress at exposure to internal or external cues that resemble the trauma; and/or (5) physiological reactivity on exposure to internal or external cues that symbolize or resemble an aspect of the trauma. Duration of these symptoms is greater than one month and symptoms cause clinically significant distress or impairment in social, occupational, or other important areas of of functioning. Scores can range from 0 to 40 and higher scores mean greater severity of re-experiencing.

  Baseline to post-treatment (week 8); Baseline to 2 months post-treatment.

• Avoidance Subscale (Criterion C) on the Clinician Administered PTSD Scale (CAPS)

  This subscale measures the frequency and intensity of persistent avoidance of stimuli associated with the trauma and numbing of general responsiveness as indicated by 3 or more of the following: (1) efforts to avoid thoughts, feelings, or conversations associated with the trauma, (2) efforts to avoid activities, places or people that arouse recollections of the trauma, (3) inability to recall an important aspect of the trauma, (4) markedly diminished interest or participation in significant activities, (5) feelings of detachment or estrangement from others, (6) restricted range of affect, and/or (7) sense of a foreshortened future. Duration of these symptoms is greater than one month and causes clinically significant distress or impairment in social, occupational, or other important areas of of functioning. Scores range from 0 to 56 with higher scores indicating greater severity of avoidance.

  Baseline to post-treatment (week 8); Baseline to 2 months post-treatment.

• Hyperarousal (Criterion D) on the Clinician Administered PTSD Scale (CAPS)

  This subscale measures the frequency and intensity of increased arousal as indicated by two or more of the following: (1) difficulty falling or staying asleep, (2) irritability or outbursts of anger, (3) difficulty concentrating, (4) hypervigilance, and/or (5) exaggerated startle response. Duration of these symptoms is greater than one month and causes clinically significant distress or impairment in social, occupational, or other important areas of of functioning. Scores range from 0 to 40. Higher scores indicate greater severity of symptoms.

  Baseline to post-treatment (week 8); baseline to 2 months post-treatment.

• PTSD Checklist-Military Version [Diagnostic and Statistical Manual (DSM) IV-TR Version]

  PCL-M: PTSD Checklist-Military version (PCL-M) is a 17-item self-report screening instrument for PTSD symptoms related to military trauma. Items are scored on a 1 (not at all bothersome) to 5 (extremely bothersome) Likert scale. Total scores range from 17 to 85. Higher scores indicate greater symptom bothersomeness. A score of \> 50 can suggest PTSD Test-retest reliability is high (r = 0.96) and validity is adequate, with a Kappa of 0.64 agreement for PTSD diagnosis compared to the Structured Clinical Interview for DSM-IV.

  Baseline to post-treatment (week 8); Baseline to 2-months post-treatment.

Secondary Outcomes (6)

• Insomnia Severity Index (ISI)

  Baseline to post-treatment (week 8); baseline to 2 months post-treatment.

• Patient Health Questionnaire (PHQ-9) for Depression

  Baseline to post-treatment (week 8); Baseline to 2-months post-treatment.

• Spielberger State Anger Inventory-Short Form

  Baseline to post-treatment (week 8); baseline to 2-months post-treatment.

• Spielberger Trait Anger Inventory-Short Form

  Baseline to post-treatment (week 8); baseline to 2-months post-treatment.

• Functional Assessment of Chronic Illness Therapy-Spiritual Wellbeing Scale-Expanded (FACIT-SpEx)

  Baseline to post-treatment (week 8); baseline to 2-months post-treatment.

Study Arms (2)

Mantram Repetition Program (MRP)

EXPERIMENTAL

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)

Present Centered Therapy (PCT)

ACTIVE COMPARATOR

Present Centered Therapy (PCT) is a form of individually-delivered 8-weekly, 1 hour sessions that are problem-oriented to improve current coping. For this study, it served as an attention control arm for the non-specific effects of individual therapist interaction.

Behavioral: Present Centered Therapy (PCT)

Interventions

Mantram Repetition Program (MRP) BEHAVIORAL

The MRP teaches three portable, mindfulness strategies to train attention and manage symptoms: 1) Mantram (sacred word) Repetition, 2) Slowing Down, and 3) One-Pointed Attention. These tools are presented as working together synergistically and cumulatively, over time, to interrupt negative thoughts, behaviors, and emotional states such as anger, rage, irritability and impatience. Participants choose their own words or phrases and are encouraged to practice repeating a mantram at any time or place. In this study, MRP is delivered individually in eight weekly, 1-hour sessions, using a standardized manual, instructor guide, and homework assignments for experiential learning.

Also known as: MRP, Mantram Meditation

Mantram Repetition Program (MRP)

Present Centered Therapy (PCT) BEHAVIORAL

The PCT is a form of individual therapy that is problem-oriented to improve current coping. It avoids details of traumatic experiences. In this study, it is delivered individually in 8 weekly, 1 hour sessions to serve as an active, attention control 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. Three components of PCT include 1) developing a therapeutic relationship for social support, 2) focusing on current problems and problem solving, 3) and setting goals.

Also known as: PCT

Present Centered Therapy (PCT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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, Massachusetts 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 or Insight Meditation
• Loving-Kindness or Compassion Meditation
• Mindfulness-Based Stress Reduction (MBSR) or other mindfulness program

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (2)

VA San Diego Healthcare System

San Diego, California, 92161, United States

Location

Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA

Bedford, Massachusetts, 01730, United States

Location

Related Publications (3)

• Bormann JE, Plumb DN, Beck DJ, Glickman M, Zhao S, Osei-Bonsu PE, Johnston JM, Herz L, Elwy AR. Portable meditation-based mantram program reduces PTSD symptoms in veterans: A randomized controlled trial. Poster session presented at: International Society for Traumatic Stress Studies Annual Symposium; 2014 Nov 1; Miami, FL.

  RESULT

• Malaktaris A, McLean CL, Mallavarapu S, Herbert MS, Kelsven S, Bormann JE, Lang AJ. Higher frequency of mantram repetition practice is associated with enhanced clinical benefits among United States Veterans with posttraumatic stress disorder. Eur J Psychotraumatol. 2022 Jun 10;13(1):2078564. doi: 10.1080/20008198.2022.2078564. eCollection 2022.

  PMID: 35713599 DERIVED

• Bormann JE, Thorp SR, Smith E, Glickman M, Beck D, Plumb D, Zhao S, Ackland PE, Rodgers CS, Heppner P, Herz LR, Elwy AR. Individual Treatment of Posttraumatic Stress Disorder Using Mantram Repetition: A Randomized Clinical Trial. Am J Psychiatry. 2018 Oct 1;175(10):979-988. doi: 10.1176/appi.ajp.2018.17060611. Epub 2018 Jun 20.

  PMID: 29921143 DERIVED

Related Links

• Home Page: Dr. Jill E. Bormann
• Bormann, JE presented VA Cyberseminar Presentation, February 2015. Symptom management for PTSD: Mantram Repetition Program randomized clinical trial results.

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Limitations and Caveats

Study was to provide interventions for both conditions (MRP and PCT) in "group" format. Due to poor recruitment and after approval from Data Monitoring Committee, the study protocol was changed to provide both interventions in "individual" format.

Results Point of Contact

• Title: Dr. Jill E. Bormann
• Organization: VA San Diego Healthcare System

jill.bormann@va.gov

858-552-8585

Study Officials

• Jill E. Bormann, PhD RN

  San Diego Veterans Healthcare System

  PRINCIPAL INVESTIGATOR

• A. Rani Elwy, PhD MSc BA

  Edith Nourse Rogers Memorial Veterans Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2011
• First Posted: January 10, 2012
• Study Start: January 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: June 1, 2015
• Last Updated: September 2, 2015
• Results First Posted: September 2, 2015

Record last verified: 2015-08

Locations

US (2)