Study Results
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View full resultsBasic Information
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COMPLETED
NA
37 participants
INTERVENTIONAL
2015-02-28
2018-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Compassion Meditation
Compassion Meditation delivered in 10 2-hour group treatment sessions.
Compassion Meditation (CM)
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.
Relaxation
Relaxation delivered in 10 2-hour group treatment sessions.
Relaxation
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).
Interventions
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Compassion Meditation (CM)
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.
Relaxation
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).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* PTSD as defined by the Diagnostic and Statistical Manual Version 5 (DSM-5)
* Capacity to consent
* Willing to commit to 8 consecutive weekly sessions lasting 2 hours in duration and to complete assessment materials.
Exclusion Criteria
* A known, untreated substance use disorder (inclusion is possible if there is evidence that the individual has been afforded and is complying with treatment for the substance problem)
* Serious Axis I mental disorders, such as psychotic disorders or bipolar type I, or serious dissociative symptoms
* Cognitive impairment that would interfere with consent or treatment
* Circumstances that lead to recurrent traumatization (e.g., engaged in a violent relationship)
* Concurrent enrollment in any other treatment specifically targeting PTSD symptoms or social functioning (e.g., couples therapy)
18 Years
ALL
No
Sponsors
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National Center for Complementary and Integrative Health (NCCIH)
NIH
Veterans Medical Research Foundation
OTHER
Responsible Party
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Ariel Lang, PhD
Research Psychologist
Principal Investigators
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Ariel J Lang, PhD
Role: PRINCIPAL_INVESTIGATOR
San Diego Veterans Healthcare System
Locations
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VA San Diego Healthcare System
San Diego, California, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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H130565
Identifier Type: -
Identifier Source: org_study_id
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