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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
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, Massachusetts area
Current daily practice of any skills of any meditation-based program - including, but not limited to:
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.
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA San Diego Healthcare System | San Diego | California | 92161 | United States | ||
| Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | 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. | ||
| 35713599 | Derived | 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. | |
| 29921143 |
| Label | URL |
|---|---|
| Home Page: Dr. Jill E. Bormann | View source |
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Five (5) enrolled participants were excluded from the trial before assignment to groups due to:
1) lost to follow-up; 2) could not commit to the study; 3) transportation difficulties. Three (3) participants were missing significant demographic data, resulting in a total of 173 for the analysis.
Veterans with a history of military-related posttraumatic stress disorder (PTSD) were recruited from January 2012 to March 2014 from outpatient clinics and primary care providers at the VA San Diego Healthcare System in San Diego, CA, and the Edith Nourse Rogers Memorial VA Hospital in Bedford, MA.
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| ID | Title | Description |
|---|---|---|
| FG000 | Mantram Repetition Program (MRP) | 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 was delivered individually in eight weekly, 1-hour sessions, using a standardized manual, instructor guide, and homework assignments for experiential learning. |
| FG001 | Present Centered Therapy (PCT) | The PCT 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Mantram Repetition Program (MRP) | The Mantram Repetition Program (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 was delivered individually in eight weekly, 1-hour sessions, using a standardized manual, instructor guide, and homework assignments for experiential learning. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Baseline data was collected from participants who scored greater or equal to 50 on the PTSD Checklist-Military (PCL-M) and greater or equal to 45 on the Clinician Administered PTSD Scale (CAPS). |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Intent to treat analysis included 89 MRP and 84 PCT participants. Completers at post-treatment included 69 MRP and 72 PCT participants. Completers at 2-months follow up included 65 MRP and 71 PCT participants. | Posted | Mean | Standard Deviation | units on a scale | Baseline to post-treatment (week 8); Baseline to 2 months post-treatment. |
|
For 2 years of the study during active recruitment, enrollment, and study participation.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mantram Repetition Program (MRP) | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Psychosis | Psychiatric disorders | Non-systematic Assessment | Participant ran out of his prescription meds to treat depression. He went to the emergency room and was admitted to the hospital with a diagnosis of Depression Psychosis-Unspecified. He withdrew from the study. |
Not provided
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jill E. Bormann | VA San Diego Healthcare System | 858-552-8585 | x2378 | jill.bormann@va.gov |
Not provided
| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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|
|
| 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. |
|
|
| 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. |
| Baseline to post-treatment (week 8); baseline to 2 months post-treatment. |
| 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. | Baseline to post-treatment (week 8); Baseline to 2-months post-treatment. |
| 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. | Baseline to post-treatment (week 8); baseline to 2-months post-treatment. |
| 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. | Baseline to post-treatment (week 8); baseline to 2-months post-treatment. |
| 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. | Baseline to post-treatment (week 8); baseline to 2-months post-treatment. |
| 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. | Baseline to post-treatment (week 8); baseline to 2-months follow-up. |
| Bedford |
| Massachusetts |
| 01730 |
| United States |
| 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. |
| Bormann, JE presented VA Cyberseminar Presentation, February 2015. Symptom management for PTSD: Mantram Repetition Program randomized clinical trial results. | View source |
| Lack of Efficacy |
|
| Moved out of area |
|
| Schedule or Transportation conflict |
|
| Started another treatment |
|
| BG001 | Present Centered Therapy (PCT) | Present Centered Individual Therapy (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. |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Description |
|---|
| OG000 | Mantram Repetition Program (MRP) | 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. |
| OG001 | Present Centered Therapy (PCT) | The PCT is a form of individual therapy that is problem-oriented to improve current coping. It typically 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. 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. |
|
|
|
| Primary | 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. | Intent to treat analysis included 89 MRP and 84 PCT participants. Completers at post-treatment included 69 MRP and 72 PCT participants. Completers at 2-months follow up included 65 MRP and 71 PCT participants. | Posted | Mean | Standard Deviation | units on a scale | Baseline to post-treatment (week 8); Baseline to 2 months post-treatment. |
|
|
|
|
| Primary | 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. | Intent to treat analysis included 89 MRP and 84 PCT participants. Completers at post-treatment included 69 MRP and 72 PCT participants. Completers at 2-months follow up included 65 MRP and 71 PCT participants. | Posted | Mean | Standard Deviation | units on a scale | Baseline to post-treatment (week 8); Baseline to 2 months post-treatment. |
|
|
|
|
| Primary | 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. | Intent to treat analysis included 89 MRP and 84 PCT participants. Completers at post-treatment included 69 MRP and 72 PCT participants. Completers at 2-months follow up included 65 MRP and 71 PCT participants. | Posted | Mean | Standard Deviation | units on a scale | Baseline to post-treatment (week 8); baseline to 2 months post-treatment. |
|
|
|
|
| Secondary | 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. | Intent to treat analysis included 89 MRP and 84 PCT participants. Completers at post-treatment included 70 MRP and 72 PCT participants. Completers at 2-months follow up included 65 MRP and 71 PCT participants. | Posted | Mean | Standard Deviation | units on a scale | Baseline to post-treatment (week 8); baseline to 2 months post-treatment. |
|
|
|
|
| Secondary | 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. | Intent to treat analysis included 89 MRP and 84 PCT participants. Completers at post-treatment included 70 MRP and 72 PCT participants. Completers at 2-months follow up included 65 MRP and 71 PCT participants. | Posted | Mean | Standard Deviation | units on a scale | Baseline to post-treatment (week 8); Baseline to 2-months post-treatment. |
|
|
|
|
| Secondary | 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. | Intent to treat analysis included 89 MRP and 84 PCT participants. Completers at post-treatment included 70 MRP and 72 PCT participants. Completers at 2-months follow up included 65 MRP and 71 PCT participants. | Posted | Mean | Standard Deviation | units on a scale | Baseline to post-treatment (week 8); baseline to 2-months post-treatment. |
|
|
|
|
| Primary | 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. | Intent to treat analysis included 89 MRP and 84 PCT participants. Completers at post-treatment included 70 MRP and 72 PCT participants. Completers at 2-months follow up included 65 MRP and 71 PCT participants. | Posted | Mean | Standard Deviation | units on a scale | Baseline to post-treatment (week 8); Baseline to 2-months post-treatment. |
|
|
|
|
| Secondary | 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. | Intent to treat analysis included 89 MRP and 84 PCT participants. Completers at post-treatment included 70 MRP and 72 PCT participants. Completers at 2-months follow up included 65 MRP and 71 PCT participants. | Posted | Mean | Standard Deviation | units on a scale | Baseline to post-treatment (week 8); baseline to 2-months post-treatment. |
|
|
|
|
| Secondary | 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. | Intent to treat analysis included 89 MRP and 84 PCT participants. Completers at post-treatment included 70 MRP and 72 PCT participants. Completers at 2-months follow up included 65 MRP and 71 PCT participants. | Posted | Mean | Standard Deviation | units on a scale | Baseline to post-treatment (week 8); baseline to 2-months post-treatment. |
|
|
|
|
| Secondary | 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. | Intent to treat analysis included 89 MRP and 84 PCT participants. Completers at post-treatment included 70 MRP and 72 PCT participants. Completers at 2-months follow up included 65 MRP and 71 PCT participants. | Posted | Mean | Standard Deviation | units on a scale | Baseline to post-treatment (week 8); baseline to 2-months follow-up. |
|
|
|
|
| 1 |
| 89 |
| 0 |
| 89 |
| EG001 | Present Centered Therapy (PCT) | The PCT is a form of individual therapy that is problem-oriented to improve current coping. It typically 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. 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. | 3 | 84 | 0 | 84 |
|
| Hospitalization for detoxification | Psychiatric disorders | Non-systematic Assessment | Participant was enrolled in study as clean and sober but relapsed. He was admitted to in-patient detoxification for substance abuse and follow-up after care. He remained in the research study. |
|
| Hospitalization for detoxification. | Psychiatric disorders | Non-systematic Assessment | Participant met study criteria upon enrollment, but had a relapse of substance abuse and was admitted to hospital for treatment. After detoxification, participant continued in the study. |
|
| Hospitalization for detoxification. | Psychiatric disorders | Non-systematic Assessment | Participant started using alcohol after 4 months of sobriety. He sought inpatient treatment and completed detoxification with follow-up. Participant remained in the study. |
|
Not provided
Not provided
Not provided
| 2-months follow-up |
|
This analysis is from baseline to 2 months post-treatment. |
| Mixed Models Analysis |
| 0.82 |
This p-value is based on a false discovery rate adjustment for multiple hypothesis testing. |
| 1-Sided |
| No |
| Superiority or Other |
| 2-months follow-up |
|
This analysis is from baseline to 2 months post-treatment |
| Mixed Models Analysis |
| <0.09 |
This p-value is based on a false discovery rate adjustment for multiple hypothesis testing. |
| 2-Sided |
| No |
| Superiority or Other |
| 2 months post-treatment |
|
This analysis is from baseline to 2 months post-treatment. |
| repeated measures |
| <.03 |
This p-value is based on a false discovery rate adjustment for multiple hypothesis testing. |
| 2-Sided |
| No |
| Superiority or Other |
| 2 months post-treatment |
|
This analysis is from baseline to 2 months post-treatment. |
| Wilcoxon (Mann-Whitney) |
| <0.006 |
This p-value is based on a false discovery rate adjustment for multiple hypothesis testing. |
| 2-Sided |
| No |
| Superiority or Other |
| 2 months post-treatment |
|
This analysis is from baseline to post-treatment. |
| Mixed Models Analysis |
| <0.49 |
This p-value is based on a false discovery rate adjustment for multiple hypothesis testing. |
| 2-Sided |
| No |
| Superiority or Other |
| 2 months post-treatment |
|
This analysis is from baseline to 2-months post-treatment. |
| Mixed Models Analysis |
| <0.99 |
This p-value is based on a false discovery rate adjustment for multiple hypothesis testing. |
| 2-Sided |
| No |
| Superiority or Other |
| 2-months Post-treatment |
|
This analysis is from baseline to 2-months post-treatment. |
| Mixed Models Analysis |
| <0.25 |
This p-value is based on a false discovery rate adjustment for multiple hypothesis testing. |
| 2-Sided |
| No |
| Superiority or Other |
| 2-months post-treatment |
|
This analysis is from baseline to 2-months post-treatment. |
| Mixed Models Analysis |
| <0.94 |
This p-value is based on a false discovery rate adjustment for multiple hypothesis testing. |
| 2-Sided |
| No |
| Superiority or Other |
| 2 months Post-treatment |
|
This analysis is from baseline to 2-months post-treatment. |
| Mixed Models Analysis |
| <0.49 |
This p-value is based on a false discovery rate adjustment for multiple hypothesis testing. |
| 2-Sided |
| No |
| Superiority or Other |
| 2 months Post-treatment |
|
This analysis is from baseline to 2-months post-treatment. |
| Mixed Models Analysis |
Mixed-effects, repeated measures models adjusting for demographic factors were implemented. |
| <0.10 |
This p-value is based on a false discovery rate adjustment for multiple hypothesis testing. |
| 2-Sided |
| No |
| Superiority or Other |