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Mantram Repetition to Manage PTSD in Veterans

Efficacy of Mantram Repetition on PTSD Symptoms in Veterans

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00120627
Enrollment
146
Registered
2005-07-18
Start date
2005-11-30
Completion date
2010-09-30
Last updated
2015-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stress Disorders, Post Traumatic

Keywords

Randomized Controlled Trial, Intervention Study, Mindfulness, Complementary Therapy, Mind-Body Relations (Metaphysics), Spiritual Therapy, Meditation, Qualitative Analysis

Brief summary

With ongoing war in Iraq, the incidence of posttraumatic stress disorder (PTSD) in combat veterans is increasing. Creation, implementation, and testing of new and innovative interventions are needed to provide additional options for enhancing the mental health of those with PTSD. Surveys indicate that veterans are interested in complementary approaches to health care. The purpose of this study is to determine the efficacy of the Mantram Repetition Program (MRP) delivered as a brief, 6-week, complementary and portable intervention. It includes frequent, silent repetitions of a mantram (mantra), a word or phrase with spiritual associations, to manage PTSD symptoms and improve quality of life military veterans with trauma.

Detailed description

The Mantram Repetition Program (MRP) is an innovative, portable meditation-based group intervention. In this study, the MRP was delivered in addition to usual care (defined as case management and medication) in a 6-week (90 minutes/week) group setting. The MRP was compared to usual care only. This 4-year study employed a mixed-methods, prospective, randomized controlled trial with qualitative phone interviews at 3 months post-intervention to explore ways that the intervention was used. Outpatient Veterans (N=146) with military-related PTSD were recruited from a single VA site and randomly assigned to the experimental arm (n=71) which consisted of usual care and the mantram program versus usual care only control group (n=76).

Interventions

BEHAVIORALMantram Repetition Program (MRP) plus Usual Care

The MRP teaches 3 strategies to train attention and manage symptoms: Mantram Repetition, Slowing Down and One-Pointed Attention. 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. MRP was delivered in a 6-week (90 minutes/week) group setting.

OTHERUsual care consisting of medication and case management

Usual care consisted of case management or meeting with Veterans at least once per month and monitoring medications, if prescribed.

Sponsors

US Department of Veterans Affairs
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Primary diagnosis of PTSD, military related * Score of greater or equal to 45 on the Clinician Administered PTSD Scale * Read and write English * Score of \> 50 on PTSD Checklist * Has a telephone with answering machine or voice mail to receive study messages * Has a Case Manager assigned for usual care * Willingness to track medications, relaxation techniques and number of case manager visit

Exclusion criteria

* Cognitive impairment including active psychosis, untreated bipolar disorder, dementia or personality disorder that interferes with group participation * Presence of active, serious suicidal ideation

Design outcomes

Primary

MeasureTime frameDescription
Clinician Administered Posttraumatic Stress Disorder (PTSD) Scale (CAPS) From DSM-IVTRPre-treatment and post-treatmentThe Clinician Administered PTSD Scale (CAPS) is used to determine PTSD symptom severity and the presence or absence of a PTSD diagnosis. The total score is obtained by summing the frequency and intensity ratings for 17 items using a 5-point scale. Scores are summed and range from 0-136. The items for frequency are rated from 0=never to 4=daily or almost everyday. The items for intensity are rated from 0=none to 4=extreme. Higher scores indicate greater symptom severity. Total scores greater than 45 indicate the presence of a PTSD diagnosis. The CAPS also has 3 subscales: 1) Criterion B (re-experiencing) has 5 items that are summed and scores range from 0 to 40; 2) Criterion C (avoidance) has 7 items that are summed and scores range from 0 to 56; and 3) Criterion D (hyper-arousal) has 5 items that are summed and scores range from 0 - 40. Higher scores indicate worse symptoms.
PTST Checklist (PCL) Civilian VersionPre-treatment and Post-treatmentThe PTSD Checklist-Civilian is a 17 item self-report measure using a 5-point Likert scale to indicate how much one is bothered by the symptoms of PTSD from trauma. Items are rated from 0=not at all to 5=extremely. Higher scores indicate greater severity and scores range from 17-85.

Secondary

MeasureTime frameDescription
Mindfulness Attention Awareness Scale (MAAS)Baseline, Post-InterventionThe Mindfulness Attention Awareness Scale (MAAS) is a 15-item questionnaire scored from 1 (almost always) to 6 (almost never) assessing individual differences in frequency of mindful states over time. Scores range from 15 to 90. Higher scores indicate greater mindful attention awareness. Mindfulness has been linked to well-being and quality of life. This questionnaire has documented content validity using factor analysis, evidence of convergent and discriminant validity, and test-retest reliability.
Short-Form (SF)-12v2 Health Quality of Life (Mental Health Component Score)Pre-treatment and post-treatmentShort-Form (SF)-12v2 measures health-related quality of life changes in mental and physical health function. The subscale SF12 Norm-Based Mental Component Summary Score rates mental health functioning. Items include feeling calm and peaceful, having alot of energy, feeling downhearted and blue -- all rated on a frequency scale from 1= all of the time to 6=none of the time. Other items ask if emotional problems such as feeling anxious or depressed interfere with (1) accomplishing less than you like and (2) not doing work or activies as carefully as usual (yes or no). Items are weighted and summed, and then converted to a 0 to 100 scale with higher scores indicating greater improvements.
Brief Symptom Inventory 18 (BSI-18) With Subscales of Depression, Anxiety, and SomatizationPre-treatment and Post-treatmentThe Brief Symptom Inventory 18 (BSI-18) is a self-report questionnaire with three subscales representing depressive symptoms, anxiety, and somatization. Each subscale consists of 6-items rated from 0=no symptoms to 4=great deal of symptoms. Scores for each subscale are summed and each subscale ranges from 0-24 with higher scores meaning worse symptoms.
Quality of Life Enjoyment & Satisfaction Questionnaire (Q-LES-Q) General ActivitiesPre- & Post-InterventionQuality of Life Enjoyment & Satisfaction Questionnaire general activities scale measures quality of life and satisfaction of 14 domains on a 1 (very poor) to 5 (very good) rating scale. Scores are summed and can range from 14 to 70 with higher scores indicating greater quality of life. Domains assessed represent physical health, mood, work/volunteer activity, household activity, social relationships, family relationships, leisure time activities, ability to function in daily life, sexual interest, economic status, living/housing situation, ability to get around physically without being unsafe, ability to do work or hobbies, and overall sense of wellbeing.
Spiritual Well-being [Functional Assessment of Chronic Illness Therapy-Spiritual Wellbeing (FACIT-Sp)]Pre- & Post-InterventionFACIT-SP a measure of existential spiritual well-being. It contains 12 items that assess levels of feeling peaceful, having meaning and purpose in life and finding comfort in faith or spiritual beliefs. Items are rated on a 5-point Likert scale: 0 = not at all and 4 = very much. Scores can range from 0 to 48. Higher scores reflect greater levels of spiritual well-being.

Countries

United States

Participant flow

Recruitment details

Recruitment began in January 2006 and ended in December 2009. Participants were recruited from PTSD outpatient clinics and other primary care clinics in the VA system in southern California.

Pre-assignment details

There were 4 subjects who dropped after random assignment and before entering the interventions. Two had scheduling conflicts and could not attend the groups at the time they were offered. One was too ill. The other did not have a reason.

Participants by arm

ArmCount
Treatment Arm: Mantram + Medication & Case Management
Mantram Repetition Program (MRP) for PTSD delivered in this study as 6-week, 90-minute per week that targeted PTSD symptoms. It was offered as an adjunct to usual care consisting of medication and case-management. The MRP includes three strategies for training attention and managing symptoms: Mantram Repetition, Slowing Down and One-Pointed Attention. 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 were presented to work together synergistically and cumulatively to interrupt negative thoughts and emotional states.
71
Control Arm: Medication & Case Management Alone
Usual care consisting of medication and case-management. Usual care consisting of medication and case management: Case management consists of meeting with Veterans at least once per month and monitoring medications, if prescribed.
75
Total146

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyWithdrawal by Subject55

Baseline characteristics

CharacteristicTreatment Arm: Mantram + Medication & Case ManagementControl Arm: Medication & Case Management AloneTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
9 Participants11 Participants20 Participants
Age, Categorical
Between 18 and 65 years
62 Participants64 Participants126 Participants
Age, Continuous56 years
STANDARD_DEVIATION 10.31
58 years
STANDARD_DEVIATION 9.86
57 years
STANDARD_DEVIATION 10.1
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
20 Participants16 Participants36 Participants
Race (NIH/OMB)
More than one race
8 Participants6 Participants14 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
3 Participants8 Participants11 Participants
Race (NIH/OMB)
White
40 Participants45 Participants85 Participants
Region of Enrollment
United States
71 participants75 participants146 participants
Sex: Female, Male
Female
3 Participants1 Participants4 Participants
Sex: Female, Male
Male
68 Participants74 Participants142 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 0

Outcome results

Primary

Clinician Administered Posttraumatic Stress Disorder (PTSD) Scale (CAPS) From DSM-IVTR

The Clinician Administered PTSD Scale (CAPS) is used to determine PTSD symptom severity and the presence or absence of a PTSD diagnosis. The total score is obtained by summing the frequency and intensity ratings for 17 items using a 5-point scale. Scores are summed and range from 0-136. The items for frequency are rated from 0=never to 4=daily or almost everyday. The items for intensity are rated from 0=none to 4=extreme. Higher scores indicate greater symptom severity. Total scores greater than 45 indicate the presence of a PTSD diagnosis. The CAPS also has 3 subscales: 1) Criterion B (re-experiencing) has 5 items that are summed and scores range from 0 to 40; 2) Criterion C (avoidance) has 7 items that are summed and scores range from 0 to 56; and 3) Criterion D (hyper-arousal) has 5 items that are summed and scores range from 0 - 40. Higher scores indicate worse symptoms.

Time frame: Pre-treatment and post-treatment

Population: Intent to treat analysis using Expectation-Maximization (EM) algorithm in SPSS for missing data; this is a maximum-likelihood method based on group assignment, demographic variables and clinical variables.

ArmMeasureGroupValue (MEAN)Dispersion
Arm 1: Mantram + Medication & Case Management (Usual Care)Clinician Administered Posttraumatic Stress Disorder (PTSD) Scale (CAPS) From DSM-IVTRBaseline CAPS Scores83.08 units on a scaleStandard Deviation 16.17
Arm 1: Mantram + Medication & Case Management (Usual Care)Clinician Administered Posttraumatic Stress Disorder (PTSD) Scale (CAPS) From DSM-IVTRPost-treatment CAPS Scores66.16 units on a scaleStandard Deviation 23.58
Arm 2: Medication & Case Management (Usual Care Alone)Clinician Administered Posttraumatic Stress Disorder (PTSD) Scale (CAPS) From DSM-IVTRBaseline CAPS Scores82.83 units on a scaleStandard Deviation 19.44
Arm 2: Medication & Case Management (Usual Care Alone)Clinician Administered Posttraumatic Stress Disorder (PTSD) Scale (CAPS) From DSM-IVTRPost-treatment CAPS Scores72.59 units on a scaleStandard Deviation 24.97
Comparison: 2 group (treatment vs. control) by 2 time (pre-intervention and post-intervention) one-way ANOVAp-value: <0.05ANOVA
p-value: <0.05Fisher Exact
Primary

PTST Checklist (PCL) Civilian Version

The PTSD Checklist-Civilian is a 17 item self-report measure using a 5-point Likert scale to indicate how much one is bothered by the symptoms of PTSD from trauma. Items are rated from 0=not at all to 5=extremely. Higher scores indicate greater severity and scores range from 17-85.

Time frame: Pre-treatment and Post-treatment

Population: Intent to treat analysis using Expectation-Maximization (EM) algorithm in SPSS, a maximum-likelihood method based on group assignment, demographic variables and clinical variables.

ArmMeasureGroupValue (MEAN)Dispersion
Arm 1: Mantram + Medication & Case Management (Usual Care)PTST Checklist (PCL) Civilian VersionPre-treatment PCL61.39 units on a scaleStandard Deviation 11.62
Arm 1: Mantram + Medication & Case Management (Usual Care)PTST Checklist (PCL) Civilian VersionPost-treatment PCL55.77 units on a scaleStandard Deviation 14.3
Arm 2: Medication & Case Management (Usual Care Alone)PTST Checklist (PCL) Civilian VersionPre-treatment PCL62.70 units on a scaleStandard Deviation 10.4
Arm 2: Medication & Case Management (Usual Care Alone)PTST Checklist (PCL) Civilian VersionPost-treatment PCL60.23 units on a scaleStandard Deviation 12.17
Comparison: 2 group (treatment vs control) by 2 time (pre-intervention and post-intervention) ANOVAp-value: <0.05ANOVA
Secondary

Brief Symptom Inventory 18 (BSI-18) With Subscales of Depression, Anxiety, and Somatization

The Brief Symptom Inventory 18 (BSI-18) is a self-report questionnaire with three subscales representing depressive symptoms, anxiety, and somatization. Each subscale consists of 6-items rated from 0=no symptoms to 4=great deal of symptoms. Scores for each subscale are summed and each subscale ranges from 0-24 with higher scores meaning worse symptoms.

Time frame: Pre-treatment and Post-treatment

ArmMeasureGroupValue (MEAN)Dispersion
Arm 1: Mantram + Medication & Case Management (Usual Care)Brief Symptom Inventory 18 (BSI-18) With Subscales of Depression, Anxiety, and SomatizationPost-treatment Depression Subscale10.60 units on a scaleStandard Deviation 6.13
Arm 1: Mantram + Medication & Case Management (Usual Care)Brief Symptom Inventory 18 (BSI-18) With Subscales of Depression, Anxiety, and SomatizationPost-treatment Anxiety Subscale10.96 units on a scaleStandard Deviation 5.63
Arm 1: Mantram + Medication & Case Management (Usual Care)Brief Symptom Inventory 18 (BSI-18) With Subscales of Depression, Anxiety, and SomatizationPre-treatment Depression Subscale12.52 units on a scaleStandard Deviation 5.77
Arm 1: Mantram + Medication & Case Management (Usual Care)Brief Symptom Inventory 18 (BSI-18) With Subscales of Depression, Anxiety, and SomatizationPre-treatment Somatization Subscale8.74 units on a scaleStandard Deviation 4.99
Arm 1: Mantram + Medication & Case Management (Usual Care)Brief Symptom Inventory 18 (BSI-18) With Subscales of Depression, Anxiety, and SomatizationPost-treatment Somatization Subscale7.66 units on a scaleStandard Deviation 4.96
Arm 1: Mantram + Medication & Case Management (Usual Care)Brief Symptom Inventory 18 (BSI-18) With Subscales of Depression, Anxiety, and SomatizationPre-treatment Anxiety Subscale12.15 units on a scaleStandard Deviation 5.56
Arm 2: Medication & Case Management (Usual Care Alone)Brief Symptom Inventory 18 (BSI-18) With Subscales of Depression, Anxiety, and SomatizationPost-treatment Somatization Subscale8.44 units on a scaleStandard Deviation 5.21
Arm 2: Medication & Case Management (Usual Care Alone)Brief Symptom Inventory 18 (BSI-18) With Subscales of Depression, Anxiety, and SomatizationPre-treatment Depression Subscale12.32 units on a scaleStandard Deviation 5.55
Arm 2: Medication & Case Management (Usual Care Alone)Brief Symptom Inventory 18 (BSI-18) With Subscales of Depression, Anxiety, and SomatizationPost-treatment Depression Subscale12.24 units on a scaleStandard Deviation 6.02
Arm 2: Medication & Case Management (Usual Care Alone)Brief Symptom Inventory 18 (BSI-18) With Subscales of Depression, Anxiety, and SomatizationPre-treatment Anxiety Subscale11.98 units on a scaleStandard Deviation 5.55
Arm 2: Medication & Case Management (Usual Care Alone)Brief Symptom Inventory 18 (BSI-18) With Subscales of Depression, Anxiety, and SomatizationPost-treatment Anxiety Subscale11.51 units on a scaleStandard Deviation 5.46
Arm 2: Medication & Case Management (Usual Care Alone)Brief Symptom Inventory 18 (BSI-18) With Subscales of Depression, Anxiety, and SomatizationPre-treatment Somatization Subscale9.23 units on a scaleStandard Deviation 5.4
Comparison: Depression Subscalep-value: <0.001ANOVA
Comparison: Anxiety Subscalep-value: =0.31ANOVA
Comparison: Somatization Subscalep-value: =0.44ANOVA
Secondary

Mindfulness Attention Awareness Scale (MAAS)

The Mindfulness Attention Awareness Scale (MAAS) is a 15-item questionnaire scored from 1 (almost always) to 6 (almost never) assessing individual differences in frequency of mindful states over time. Scores range from 15 to 90. Higher scores indicate greater mindful attention awareness. Mindfulness has been linked to well-being and quality of life. This questionnaire has documented content validity using factor analysis, evidence of convergent and discriminant validity, and test-retest reliability.

Time frame: Baseline, Post-Intervention

ArmMeasureGroupValue (MEAN)Dispersion
Arm 1: Mantram + Medication & Case Management (Usual Care)Mindfulness Attention Awareness Scale (MAAS)Post-Intervention Mindful Attention Awareness50.99 units on a scaleStandard Deviation 13.74
Arm 1: Mantram + Medication & Case Management (Usual Care)Mindfulness Attention Awareness Scale (MAAS)Baseline Mindfulness Attention Awareness46.60 units on a scaleStandard Deviation 13.4
Arm 2: Medication & Case Management (Usual Care Alone)Mindfulness Attention Awareness Scale (MAAS)Post-Intervention Mindful Attention Awareness46.04 units on a scaleStandard Deviation 13.75
Arm 2: Medication & Case Management (Usual Care Alone)Mindfulness Attention Awareness Scale (MAAS)Baseline Mindfulness Attention Awareness47.80 units on a scaleStandard Deviation 12.02
p-value: <0.001ANOVA
p-value: <0.001Mediation using Sobel Test
Secondary

Quality of Life Enjoyment & Satisfaction Questionnaire (Q-LES-Q) General Activities

Quality of Life Enjoyment & Satisfaction Questionnaire general activities scale measures quality of life and satisfaction of 14 domains on a 1 (very poor) to 5 (very good) rating scale. Scores are summed and can range from 14 to 70 with higher scores indicating greater quality of life. Domains assessed represent physical health, mood, work/volunteer activity, household activity, social relationships, family relationships, leisure time activities, ability to function in daily life, sexual interest, economic status, living/housing situation, ability to get around physically without being unsafe, ability to do work or hobbies, and overall sense of wellbeing.

Time frame: Pre- & Post-Intervention

Population: Intent to treat analysis using Expectation-Maximization (EM) algorithm in SPSS to replace missing data, a maximum-likelihood method based on group assignment, demographic variables and clinical variables.

ArmMeasureGroupValue (MEAN)Dispersion
Arm 1: Mantram + Medication & Case Management (Usual Care)Quality of Life Enjoyment & Satisfaction Questionnaire (Q-LES-Q) General ActivitiesBaseline Quality of Life Enjoyment & Satisfaction35.52 units on a scaleStandard Deviation 9.28
Arm 1: Mantram + Medication & Case Management (Usual Care)Quality of Life Enjoyment & Satisfaction Questionnaire (Q-LES-Q) General ActivitiesPost-intervention Quality of Life Enjoyment & Sati39.34 units on a scaleStandard Deviation 9.33
Arm 2: Medication & Case Management (Usual Care Alone)Quality of Life Enjoyment & Satisfaction Questionnaire (Q-LES-Q) General ActivitiesBaseline Quality of Life Enjoyment & Satisfaction34.98 units on a scaleStandard Deviation 9.22
Arm 2: Medication & Case Management (Usual Care Alone)Quality of Life Enjoyment & Satisfaction Questionnaire (Q-LES-Q) General ActivitiesPost-intervention Quality of Life Enjoyment & Sati35.75 units on a scaleStandard Deviation 8.45
p-value: <0.01ANOVA
Secondary

Short-Form (SF)-12v2 Health Quality of Life (Mental Health Component Score)

Short-Form (SF)-12v2 measures health-related quality of life changes in mental and physical health function. The subscale SF12 Norm-Based Mental Component Summary Score rates mental health functioning. Items include feeling calm and peaceful, having alot of energy, feeling downhearted and blue -- all rated on a frequency scale from 1= all of the time to 6=none of the time. Other items ask if emotional problems such as feeling anxious or depressed interfere with (1) accomplishing less than you like and (2) not doing work or activies as carefully as usual (yes or no). Items are weighted and summed, and then converted to a 0 to 100 scale with higher scores indicating greater improvements.

Time frame: Pre-treatment and post-treatment

Population: Intent to treat analysis using Expectation-Maximization (EM) algorithm in SPSS to replace missing values; a maximum-likelihood method based on group assignment, demographic variables and clinical variables.

ArmMeasureGroupValue (MEAN)Dispersion
Arm 1: Mantram + Medication & Case Management (Usual Care)Short-Form (SF)-12v2 Health Quality of Life (Mental Health Component Score)Pre-treatment Mental Health Scores33.15 units on a scaleStandard Deviation 9.08
Arm 1: Mantram + Medication & Case Management (Usual Care)Short-Form (SF)-12v2 Health Quality of Life (Mental Health Component Score)Post-treatment Mental Health Scores36.30 units on a scaleStandard Deviation 8.94
Arm 2: Medication & Case Management (Usual Care Alone)Short-Form (SF)-12v2 Health Quality of Life (Mental Health Component Score)Post-treatment Mental Health Scores33.17 units on a scaleStandard Deviation 7.58
Arm 2: Medication & Case Management (Usual Care Alone)Short-Form (SF)-12v2 Health Quality of Life (Mental Health Component Score)Pre-treatment Mental Health Scores32.89 units on a scaleStandard Deviation 7.85
Comparison: Intent to treat analysis using Expectation-Maximization (EM) algorithm in SPSS, a maximum-likelihood method based on group assignment, demographic variables and clinical variables.p-value: <0.05ANOVA
Secondary

Spiritual Well-being [Functional Assessment of Chronic Illness Therapy-Spiritual Wellbeing (FACIT-Sp)]

FACIT-SP a measure of existential spiritual well-being. It contains 12 items that assess levels of feeling peaceful, having meaning and purpose in life and finding comfort in faith or spiritual beliefs. Items are rated on a 5-point Likert scale: 0 = not at all and 4 = very much. Scores can range from 0 to 48. Higher scores reflect greater levels of spiritual well-being.

Time frame: Pre- & Post-Intervention

Population: Intent to treat analysis using Expectation-Maximization (EM) algorithm in SPSS, a maximum-likelihood method based on group assignment, demographic variables and clinical variables.

ArmMeasureGroupValue (MEAN)Dispersion
Arm 1: Mantram + Medication & Case Management (Usual Care)Spiritual Well-being [Functional Assessment of Chronic Illness Therapy-Spiritual Wellbeing (FACIT-Sp)]Baseline Spiritual Wellbeing Score22.30 units on a scaleStandard Deviation 8.36
Arm 1: Mantram + Medication & Case Management (Usual Care)Spiritual Well-being [Functional Assessment of Chronic Illness Therapy-Spiritual Wellbeing (FACIT-Sp)]Post-intervention Spiritual Wellbeing Score26.72 units on a scaleStandard Deviation 9.04
Arm 2: Medication & Case Management (Usual Care Alone)Spiritual Well-being [Functional Assessment of Chronic Illness Therapy-Spiritual Wellbeing (FACIT-Sp)]Baseline Spiritual Wellbeing Score20.59 units on a scaleStandard Deviation 8.27
Arm 2: Medication & Case Management (Usual Care Alone)Spiritual Well-being [Functional Assessment of Chronic Illness Therapy-Spiritual Wellbeing (FACIT-Sp)]Post-intervention Spiritual Wellbeing Score20.04 units on a scaleStandard Deviation 8.84
Comparison: 2 group (treatment vs control) by 2 time points (pre-intervention and post-intervention)p-value: <0.0001ANOVA
Post Hoc

Avoidance (Criterion C) Subscale of the Clinician Administered PTSD Scale (CAPS) From Diagnostic and Statistical Manual, 4th Ed, Text Revision

Avoidance (Criterion C) Subscale assesses symptoms of feeling detached and estranged from others; markedly diminished interest in significant activities; efforts to avoid thoughts, feelings, or conversations associated with the trauma; and efforts to avoid activities, places, or people that arouse recollections of the trauma. Items are rated by frequency on a scale of 0 (never) to 4 (daily or almost every day) and on intensity on a scale of 0 (none) to 4 (extreme, incapacitating distress). Score are summed for a total subscale score ranging from 0 to 56, higher scores indicating greater levels of symptoms.

Time frame: Pre-treatment and Post-treatment

ArmMeasureGroupValue (MEAN)Dispersion
Arm 1: Mantram + Medication & Case Management (Usual Care)Avoidance (Criterion C) Subscale of the Clinician Administered PTSD Scale (CAPS) From Diagnostic and Statistical Manual, 4th Ed, Text RevisionPre-treatment Avoidance Subscale32.99 units on a scaleStandard Deviation 7.65
Arm 1: Mantram + Medication & Case Management (Usual Care)Avoidance (Criterion C) Subscale of the Clinician Administered PTSD Scale (CAPS) From Diagnostic and Statistical Manual, 4th Ed, Text RevisionPost-treatment Subscale27.25 units on a scaleStandard Deviation 12.12
Arm 2: Medication & Case Management (Usual Care Alone)Avoidance (Criterion C) Subscale of the Clinician Administered PTSD Scale (CAPS) From Diagnostic and Statistical Manual, 4th Ed, Text RevisionPre-treatment Avoidance Subscale33.73 units on a scaleStandard Deviation 9.78
Arm 2: Medication & Case Management (Usual Care Alone)Avoidance (Criterion C) Subscale of the Clinician Administered PTSD Scale (CAPS) From Diagnostic and Statistical Manual, 4th Ed, Text RevisionPost-treatment Subscale30.59 units on a scaleStandard Deviation 12.83
p-value: =0.18ANOVA
Post Hoc

Hyper-arousal (Criterion D) Subscale of CAPS From Diagnostic and Statistical Manual, 4th Ed., Text Revision

Hyper-arousal Subscale (Criterion D) assesses symptoms of difficulty falling or staying asleep, irritability or outbursts of anger, difficulty concentrating, hypervigilance, and exaggerated startle response. Items are rated by frequency on a scale of 0 (never) to 4 (daily or almost every day) and on intensity on a scale of 0 (none) to 4 (extreme, incapacitating distress). Scores are summed for a total subscale score ranging from 0 to 40, higher scores indicating greater levels of symptoms.

Time frame: Pre-treatment to Post-treatment

ArmMeasureGroupValue (MEAN)Dispersion
Arm 1: Mantram + Medication & Case Management (Usual Care)Hyper-arousal (Criterion D) Subscale of CAPS From Diagnostic and Statistical Manual, 4th Ed., Text RevisionPre-treatment Hyperarousal Subscale27.56 units on a scaleStandard Deviation 6.12
Arm 1: Mantram + Medication & Case Management (Usual Care)Hyper-arousal (Criterion D) Subscale of CAPS From Diagnostic and Statistical Manual, 4th Ed., Text RevisionPost-treatment Hyperarousal Subscale23.37 units on a scaleStandard Deviation 7.33
Arm 2: Medication & Case Management (Usual Care Alone)Hyper-arousal (Criterion D) Subscale of CAPS From Diagnostic and Statistical Manual, 4th Ed., Text RevisionPre-treatment Hyperarousal Subscale27.39 units on a scaleStandard Deviation 5.56
Arm 2: Medication & Case Management (Usual Care Alone)Hyper-arousal (Criterion D) Subscale of CAPS From Diagnostic and Statistical Manual, 4th Ed., Text RevisionPost-treatment Hyperarousal Subscale25.27 units on a scaleStandard Deviation 7.36
p-value: <0.01ANOVA
Post Hoc

Re-experiencing (Criterion B) From the Clinician Administered PTSD Scale (CAPS) Clinician Administered PTSD Scale Defined by the Diagnostic and Statistical Manual, 4th Ed, Text Revision

Re-experiencing Subscale (Criterion B) assesses symptoms of persistent re-experiencing of the traumatic event. This may include recurrent, intrusive recollections of the traumatic event; recurring dreams of the event; acting or feeling as if the traumatic event were occuring; and intense psychological distress at exposure to internal or external cues that symbolize or represent the event. Items are rated by frequency on a scale of 0 (never) to 4 (daily or almost every day) and on intensity on a scale of 0 (none) to 4 (extreme, incapacitating distress). Score are summed for a total subscale score ranging from 0 to 40, higher scores indicating greater levels of symptoms.

Time frame: Pre-treatment to Post-treatment

ArmMeasureGroupValue (MEAN)Dispersion
Arm 1: Mantram + Medication & Case Management (Usual Care)Re-experiencing (Criterion B) From the Clinician Administered PTSD Scale (CAPS) Clinician Administered PTSD Scale Defined by the Diagnostic and Statistical Manual, 4th Ed, Text RevisionPre-treatment Re-experiencing Subscale22.59 units on a scaleStandard Deviation 6.67
Arm 1: Mantram + Medication & Case Management (Usual Care)Re-experiencing (Criterion B) From the Clinician Administered PTSD Scale (CAPS) Clinician Administered PTSD Scale Defined by the Diagnostic and Statistical Manual, 4th Ed, Text RevisionPost-treatment Re-experiencing Subscale16.57 units on a scaleStandard Deviation 8.58
Arm 2: Medication & Case Management (Usual Care Alone)Re-experiencing (Criterion B) From the Clinician Administered PTSD Scale (CAPS) Clinician Administered PTSD Scale Defined by the Diagnostic and Statistical Manual, 4th Ed, Text RevisionPre-treatment Re-experiencing Subscale22.47 units on a scaleStandard Deviation 7.2
Arm 2: Medication & Case Management (Usual Care Alone)Re-experiencing (Criterion B) From the Clinician Administered PTSD Scale (CAPS) Clinician Administered PTSD Scale Defined by the Diagnostic and Statistical Manual, 4th Ed, Text RevisionPost-treatment Re-experiencing Subscale17.05 units on a scaleStandard Deviation 8.84
Comparison: Post-hoc analysisp-value: =0.66ANOVA

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026