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Stress Disorders, Post-TraumaticPhase 3NCT01506323

Mantram Repetition Meditation for Veterans With PTSD

A Phase 3 study testing Mantram Repetition Program (MRP) and Present Centered Therapy (PCT) in people with Stress Disorders, Post-Traumatic, run by US Department of Veterans Affairs at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stress Disorders, Post-Traumatic
What is being tested?
Mantram Repetition Program (MRP) and Present Centered Therapy (PCT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
181 participants
Where
2 sitesUnited States
Study dates
Jan 2012to Jun 2015
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 22Show fewer
  • 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
  • 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 the study team, would interfere with the safety of prospective participants or their need for treatment.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA

    Bedford, Massachusetts, 01730

  • VA San Diego Healthcare System

    San Diego, California, 92161

Other trials in United States

About this study

Official title: Portable Mantram Meditation for Veterans With Military Related PTSD

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.

Read the detailed description

The investigators conducted a prospective, parallel group, two-site, randomized clinical trial on the therapeutic treatment efficacy of the Mantram Repetition Program (MRP) by offering it as a stand-alone intervention, compared to an attention control condition of Present Centered Therapy (PCT) in a diverse sample of Veterans with post-traumatic stress disorder (PTSD). Primary outcomes included clinician-assessed and self-reported PTSD symptom severity. Secondary outcomes included insomnia, depression, anger, spiritual well-being, and mindfulness. Veterans were were recruited from a variety of clinics, including primary care, women's health, and specialty clinics in two geographical locations within the Department of Veterans Affairs healthcare system.

Being tested
Mantram Repetition Program (MRP), Present Centered Therapy (PCT)
Keywords
Complementary Therapy, Stress Disorders, Post-Traumatic, Veterans Health, Clinical Trials, Randomized, Mindfulness, Spirituality, Meditation, Mind-body therapy
Medical subject headings
Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mantram Repetition Program (MRP)Behavioural

    Also called MRP, Mantram Meditation

    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.

  • Present Centered Therapy (PCT)Behavioural

    Also called PCT

    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.

Study groups in NCT01506323
Study groupRoleWhat they receive
Mantram Repetition Program (MRP)ExperimentalA 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.
Receives: Behavioral: Mantram Repetition Program (MRP)
Present Centered Therapy (PCT)Active comparatorPresent 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.
Receives: Behavioral: Present Centered Therapy (PCT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. 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.

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

Secondary outcomes (6)

  1. Insomnia Severity Index (ISI)

    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 with higher scores meaning greater insomnia. Total scores range from 0-28. Original results were interpreted as 0-7 = no clinically significant insomnia, 8-14 = sub-threshold insomnia, 15-21 = moderately severe clinical insomnia and 21-28 = severe clinical insomnia. Later recommendations for a clinical, not community sample, are a cut-off of 11 points.

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

  2. Patient Health Questionnaire (PHQ-9) for Depression

    PHQ-9 is a 9-item depression screening tool based on the diagnostic criteria for major depressive disorder in the DSM-IV. Each item is rated from a 0 (not at all) to 3 (nearly every day) scale. Items are summed and total scores range from 0 to 27. Higher scores indicate worse depression. A score of 11 or more considered probable depression and 20 or more is considered severe depression. It is well-validated and widely-used in medical settings such as primary care. The PHQ-9 includes the two major symptom domains characteristic of depression: affective and somatic symptoms.

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

  3. Spielberger State Anger Inventory-Short Form

    Spielberger State Anger Inventory-Short Form is a 10-item questionnaire with 4-point Likert scale to measure anger as an emotional state. Scores range from 10 to 40 with higher scores indicating more anger. Concurrent validity has been supported by correlations with measures of hostility, neuroticism, and anxiety. Internal consistency reliability has been reported as good to excellent.

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

  4. Spielberger Trait Anger Inventory-Short Form

    Spielberger Trait Anger Inventory-Short Form is a 10-item questionnaire with 4-point Likert scale used to measure anger as a personality trait. Scores range from 10 to 40 with higher scores indicating more trait anger. Concurrent validity has been supported by correlations with measures of hostility, neuroticism, and anxiety. Internal consistency reliability has been reported as good to excellent.

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

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

    The FACIT-SpEx 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 from 0 (not at all) to 4 (very much). Total scores range from 0 to 92. 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.

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

  6. Five Facet Mindfulness Questionnaire (FFMQ)

    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. Each subscale contains either 7 or 8 items that are rated on a 1 (never or very rarely true) to 5 (very often or always true) Likert scale. Items are randomly reversed scored and higher scores represent greater levels of mindfulness. Total scores range from 39 to 195.

    Measured: Baseline to post-treatment (week 8); baseline to 2-months follow-up.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2012 (estimated)
  2. Study startJan 2012
  3. Primary completionMar 2014
  4. Study completionJun 2015

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
181 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01506323
Sponsor's protocol ID
SPLE-003-11S
Status last verified
Aug 2015
First submitted
19 Dec 2011
Last updated
2 Sep 2015
Data monitoring committee
Yes

Publications

  • 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.

  • 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.

    PubMed 35713599

  • 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.

    PubMed 29921143

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Mantram Repetition Program (MRP) and Present Centered Therapy (PCT) in people with Stress Disorders, Post-Traumatic, run by US Department of Veterans Affairs 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 6 inclusion and 22 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 2 Sep 2015. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Sep 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 (CAPS) Diagnostic and Statistical Manual, 4th ed., Text Revision (DSM-IV) (time frame: Baseline to post-treatment (week 8); Baseline to 2 months post-treatment.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01506323, which also lists 3 linked publications.

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 2 Sep 2015.

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