Posttraumatic Stress Disorder
Conditions
Keywords
PTSD, Psychotherapy, Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF), Veterans
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALCompassion 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.
BEHAVIORALRelaxation
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).
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
Veterans Medical Research Foundation
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
* Veteran of at least 18 years of age * 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
* Serious suicidality or homicidality that has required urgent or emergent evaluation or treatment within the past three months * 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinician Administered PTSD Scale -5 (CAPS-5) PTSD Severity | Baseline and 10 weeks | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 17 |
| 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). | 20 |
| Total | 37 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 7 | 9 |
Baseline characteristics
| Characteristic | CBCT-Vet | Total | Veteran.Calm |
|---|---|---|---|
| Age, Continuous | 45.5 years STANDARD_DEVIATION 16.6 | 49.11 years STANDARD_DEVIATION 14.5 | 52.7 years STANDARD_DEVIATION 11.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 10 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants | 18 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 6 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 5 Participants | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 7 Participants | 14 Participants | 7 Participants |
| Region of Enrollment United States | 17 participants | 37 participants | 20 participants |
| Sex: Female, Male Female | 4 Participants | 7 Participants | 3 Participants |
| Sex: Female, Male Male | 10 Participants | 21 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 20 |
| other Total, other adverse events | 0 / 17 | 0 / 20 |
| serious Total, serious adverse events | 0 / 17 | 0 / 20 |
Outcome results
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
Time frame: Baseline and 10 weeks
Population: Completer analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CBCT-Vet | Clinician Administered PTSD Scale -5 (CAPS-5) PTSD Severity | Baseline | 35.8 units on a scale | Standard Deviation 13.9 |
| CBCT-Vet | Clinician Administered PTSD Scale -5 (CAPS-5) PTSD Severity | 10 weeks | 20.4 units on a scale | Standard Deviation 11.8 |
| Veteran.Calm | Clinician Administered PTSD Scale -5 (CAPS-5) PTSD Severity | 10 weeks | 35.3 units on a scale | Standard Deviation 7.7 |
| Veteran.Calm | Clinician Administered PTSD Scale -5 (CAPS-5) PTSD Severity | Baseline | 37.9 units on a scale | Standard Deviation 11.9 |