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| ID | Type | Description | Link |
|---|---|---|---|
| 1R34AT007936-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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The goal of this project is to refine an existing compassion meditation protocol for individuals with posttraumatic stress disorder (PTSD), to examine the safety and feasibility of this approach and to collect data to make initial estimates of efficacy.
There is considerable public and professional interest in complementary and alternative approaches, including meditation, for managing posttraumatic stress disorder (PTSD), but there is little empirical support to guide their use. Multiple meditative techniques can be applied to the amelioration of this disorder, and the literature suggests that they operate by different mechanisms. Compassion meditation is a meditative practice focused on the wish that others and the self may be free of suffering. Because this particular form of meditation has been shown to elicit positive emotion and feelings of connection with other people, it is uniquely well suited to addressing PTSD, which is characterized by strong negative affect, deficits in positive emotion and social connectedness.
Compassion meditation has not been evaluated for use with PTSD patients; therefore, the goal of this project is to refine an existing compassion meditation protocol for individuals with PTSD, to examine the safety and feasibility of this approach and to collect data to make initial estimates of efficacy. The proposed project will be completed in two phases.
In phase one, the compassion meditation protocol will be executed with individuals with PTSD and iteratively refined based on therapist and participant feedback. In addition, a relaxation protocol that was used in a previous PTSD trial will be modified to match the length and format of the meditative practice.
In phase two, the investigators will complete a pilot study to examine the feasibility of conducting a randomized trial comparing these interventions and to provide information that will allow us to better design future projects. Ultimately, the research informed by this project may provide an additional option for treatment of PTSD, which would be an important contribution because existing treatment approaches are not universally acceptable or effective.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Compassion Meditation | Experimental | Compassion Meditation delivered in 10 2-hour group treatment sessions. |
|
| Relaxation | Active Comparator | Relaxation delivered in 10 2-hour group treatment sessions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Compassion Meditation (CM) | Behavioral | Compassion meditation is a meditative practice focused on the wish that others and the self may be free of suffering. Because this particular form of meditation has been shown to elicit positive emotion and feelings of connection with other people, it is uniquely well suited to addressing PTSD, which is characterized by strong negative affect, deficits in positive emotion and social connectedness. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinician Administered PTSD Scale -5 (CAPS-5) PTSD Severity | Clinical interview that quantifies PTSD symptomatology according to DSM-5, generating a continuous measure of severity (range 0-80) where higher scores indicate more symptomatology | Baseline and 10 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ariel J Lang, PhD | San Diego Veterans Healthcare System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA San Diego Healthcare System | San Diego | California | 92161 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | CBCT-Vet | Cognitively Based Compassion Training, Veteran Version (CBCT-Vet) delivered in 10 1.5-hour group treatment sessions. CBCT-Vet is a compassion meditation practice focused on the wish that others and the self may be free of suffering. Because this particular form of meditation has been shown to elicit positive emotion and feelings of connection with other people, it is uniquely well suited to addressing PTSD, which is characterized by strong negative affect, deficits in positive emotion and social connectedness. |
| FG001 | Veteran.Calm | Veteran.calm delivered in 10 1.5-hour group treatment sessions. Veteran.calm is a form of relaxation training that was selected as the control condition because it is a good match for nonspecific aspects of the meditative practice (e.g., attention, support, contact with a mental health provider) and it is structurally similar to meditation (e.g., restful, mind-body focus, in session and at home exercises). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CBCT-Vet | CBCT-Vet delivered in 10 1.5-hour group treatment sessions. CBCT-Vet is a compassion meditation practice focused on the wish that others and the self may be free of suffering. Because this particular form of meditation has been shown to elicit positive emotion and feelings of connection with other people, it is uniquely well suited to addressing PTSD, which is characterized by strong negative affect, deficits in positive emotion and social connectedness. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Data presented on participants who began the intervention rather than on the intent-to-treat sample. |
| 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 -5 (CAPS-5) PTSD Severity | Clinical interview that quantifies PTSD symptomatology according to DSM-5, generating a continuous measure of severity (range 0-80) where higher scores indicate more symptomatology | Completer analysis | Posted | Mean | Standard Deviation | units on a scale | Baseline and 10 weeks |
|
12 weeks (duration of participant involvement)
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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 | CBCT-Vet | CBCT-Vet delivered in 10 1.5-hour group treatment sessions. CBCT-Vet is a compassion meditation practice focused on the wish that others and the self may be free of suffering. Because this particular form of meditation has been shown to elicit positive emotion and feelings of connection with other people, it is uniquely well suited to addressing PTSD, which is characterized by strong negative affect, deficits in positive emotion and social connectedness. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ariel Lang | Veterans Medical Research Foundation | 858-552-8585 | 5359 | ajlang@ucsd.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 15, 2014 | Aug 5, 2018 | Prot_SAP_000.pdf |
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| 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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| Relaxation | Behavioral | Relaxation Training is selected as the control condition because it is a good match for nonspecific aspects of the meditative practice (e.g., attention, support, contact with a mental health provider) and it is structurally similar to meditation (e.g., restful, in session and at home exercises). |
|
| BG001 | Veteran.Calm | Veteran.calm delivered in 10 1.5-hour group treatment sessions. Veteran.calm is a form of relaxation training that was selected as the control condition because it is a good match for nonspecific aspects of the meditative practice (e.g., attention, support, contact with a mental health provider) and it is structurally similar to meditation (e.g., restful, mind-body focus, in session and at home exercises). |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Presenting data on those who began treatment | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Presenting data on those who initiated treatment | Count of Participants | Participants |
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| Race (NIH/OMB) | Presenting data on those who began treatment | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| OG001 |
| Veteran.Calm |
Veteran.calm delivered in 10 1.5-hour group treatment sessions. Veteran.calm is a form of relaxation training that was selected as the control condition because it is a good match for nonspecific aspects of the meditative practice (e.g., attention, support, contact with a mental health provider) and it is structurally similar to meditation (e.g., restful, mind-body focus, in session and at home exercises). |
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| 0 |
| 17 |
| EG001 | Veteran.Calm | Veteran.calm delivered in 10 1.5-hour group treatment sessions. Veteran.calm is a form of relaxation training that was selected as the control condition because it is a good match for nonspecific aspects of the meditative practice (e.g., attention, support, contact with a mental health provider) and it is structurally similar to meditation (e.g., restful, mind-body focus, in session and at home exercises). | 0 | 20 | 0 | 20 | 0 | 20 |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
|