Ptsd
Conditions
Brief summary
Investigators will recruit up to 20 veterans with PTSD. Participants will be randomized into two conditions: MBSR and Health and Wellness Education (HWE; control group). Participants will be randomized at a 1:1 ratio. Purpose of the study is to learn how mindfulness meditation may be helpful in treating PTSD. Participants will undergo 2 screening sessions, 8 weekly sessions of intervention (MBSR or HWE), 3 laboratory visits that will include completing survey questionnaires, stress test and recording of heart rate, blood pressure and breathing rate.
Interventions
BEHAVIORALMindfulness-Based Stress Reduction (MBSR)
MBSR consists of weekly two-hour sessions for eight weeks, and a 7.5 hour retreat between weeks 6 and 7. The MBSR intervention will be facilitated by an experienced and certified MBSR teacher. MBSR curriculum strongly encourages completion of home practice assignments (\ 30 minutes daily) to help integration of concepts into daily life. Participants will receive audio CDs and a DVD to help guide home practice.
BEHAVIORALHealth and Wellness Education (HWE)
HWE is a didactic-based group intervention designed as an active comparator for randomized-controlled trials of MBSR. HWE provides instruction to participants regarding improving their emotional and physical health. In contrast to MBSR, there are no attempts to train participants' breathing, movement, or meditation habits or practices. HWE is administered in 8 weekly 2.5-hour classes with home practice to be completed between sessions (matched to MBSR for amount and effort). HWE also features one extended 7.5-hour retreat, similar to MBSR.84 Dr. Autumn Gallegos (consultant) has conducted trials of MBSR among veterans with PTSD using a HWE control group, and will provide mentorship to the PI in administering the HWE intervention. Dr. Kaplan and a trained RA will facilitate HWE.
Sponsors
Oregon Clinical and Translational Research Institute
National Center for Advancing Translational Sciences (NCATS)
Oregon Health and Science University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Adult (18-85yo) * Military veteran * Experiencing PTSD symptoms * Reading and speaking in English * Be able to travel to OHSU for three two-hour lab visits, 8 weekly intervention sessions and one long extended session, and a two- hour focus group
Exclusion criteria
* Pregnancy * Severe untreated depression, cognitive impairment, or active suicidality\* * Life-threatening or severely disabling medical conditions * Excessive use of alcohol, nicotine, or cannabis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Qualitative Interview Targeting Feasibility of MBSR | 2 weeks post conclusion of intervention | Qualitative data generated via focus group interviews. Questions will include common barriers to completing the intervention and strategies utilized by participants to maximize adherence. |
| Qualitative Interview Targeting Acceptability of MBSR | 2 weeks post conclusion of intervention. Data were not collected due to prematurely study closure due to PI change of career. | Qualitative data generated via focus group interviews. Questions will include ratings of the relevance of the content presented to participants' lives, as well as assessment of the method of presentation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PTSD Symptoms 1 | Pre (week 0), mid (week 4), and post intervention (week 10). | Measured by a self-report questionnaire: the PTSD Symptom Checklist (PCL). Scores range from 0-4 and higher scores indicate more severe PTSD symptoms. |
| Psychological Resilience 1 | Pre (week 0), mid (week 4), and post intervention (week 10). Data were not collected due to prematurely study closure due to PI change of career. | Measured by self-report measure: Brief Resilience Scale (BRS). Scale ranges from 1-5 and higher scores indicate higher psychological resilience. |
| PTSD Symptoms | Pre (week 0), mid (week 4), and post intervention (week 10). | Measured a clinician-administered semi-structured interview: the Clinician-Administered PTSD Scale (CAPS-5). Symptoms are rated for severity (0-absent; 1-mild/subthreshold; 2-moderate/threshold; 3-severe/markedly elevated; 4-extreme/incapacitating) and the presence of distress (minimal; clearly present; pronounced; extreme). Symptom clusters are also rated for the likelihood that they are related to the index trauma (definite; probable; unlikely). |
| Psychological Resilience 2 | Pre (week 0), mid (week 4), and post intervention (week 10). | Measured by self-report measure: Connor-Davidson Resilience Scale (CD-RISC). Scores range from 0-4 and higher scores indicate higher psychological resilience. |
| Blood Pressure Reactivity | Pre (week 0), mid (week 4), and post intervention (week 10). | Reactivity of physiological parameters (e.g., systolic and diastolic blood pressure) to a cognitive stress task. |
Countries
United States
Participant flow
Pre-assignment details
7 participants screened eligible and were consented. However no participants were assigned to arms, and no participants began study interventions or received treatment due to closure of study resulting from PI career change.
Participants by arm
| Arm | Count |
|---|---|
| Mindfulness-Based Stress Reduction Mindfulness-Based Stress Reduction (MBSR): MBSR consists of weekly two-hour sessions for eight weeks, and a 7.5 hour retreat between weeks 6 and 7. The MBSR intervention will be facilitated by an experienced and certified MBSR teacher. MBSR curriculum strongly encourages completion of home practice assignments (\
30 minutes daily) to help integration of concepts into daily life. Participants will receive audio CDs and a DVD to help guide home practice. | 0 |
| Health and Wellness Education Health and Wellness Education (HWE): HWE is a didactic-based group intervention designed as an active comparator for randomized-controlled trials of MBSR. HWE provides instruction to participants regarding improving their emotional and physical health. In contrast to MBSR, there are no attempts to train participants' breathing, movement, or meditation habits or practices. HWE is administered in 8 weekly 2.5-hour classes with home practice to be completed between sessions (matched to MBSR for amount and effort). HWE also features one extended 7.5-hour retreat, similar to MBSR.84 Dr. Autumn Gallegos (consultant) has conducted trials of MBSR among veterans with PTSD using a HWE control group, and will provide mentorship to the PI in administering the HWE intervention. Dr. Kaplan and a trained RA will facilitate HWE. | 0 |
| Total | 0 |
Baseline characteristics
| Characteristic | — |
|---|---|
| Region of Enrollment United States | — participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Qualitative Interview Targeting Acceptability of MBSR
Qualitative data generated via focus group interviews. Questions will include ratings of the relevance of the content presented to participants' lives, as well as assessment of the method of presentation.
Time frame: 2 weeks post conclusion of intervention. Data were not collected due to prematurely study closure due to PI change of career.
Primary
Qualitative Interview Targeting Feasibility of MBSR
Qualitative data generated via focus group interviews. Questions will include common barriers to completing the intervention and strategies utilized by participants to maximize adherence.
Time frame: 2 weeks post conclusion of intervention
Population: Data were not collected due to prematurely study closure due to PI change of career.
Secondary
Blood Pressure Reactivity
Reactivity of physiological parameters (e.g., systolic and diastolic blood pressure) to a cognitive stress task.
Time frame: Pre (week 0), mid (week 4), and post intervention (week 10).
Secondary
Psychological Resilience 1
Measured by self-report measure: Brief Resilience Scale (BRS). Scale ranges from 1-5 and higher scores indicate higher psychological resilience.
Time frame: Pre (week 0), mid (week 4), and post intervention (week 10). Data were not collected due to prematurely study closure due to PI change of career.
Secondary
Psychological Resilience 2
Measured by self-report measure: Connor-Davidson Resilience Scale (CD-RISC). Scores range from 0-4 and higher scores indicate higher psychological resilience.
Time frame: Pre (week 0), mid (week 4), and post intervention (week 10).
Secondary
PTSD Symptoms
Measured a clinician-administered semi-structured interview: the Clinician-Administered PTSD Scale (CAPS-5). Symptoms are rated for severity (0-absent; 1-mild/subthreshold; 2-moderate/threshold; 3-severe/markedly elevated; 4-extreme/incapacitating) and the presence of distress (minimal; clearly present; pronounced; extreme). Symptom clusters are also rated for the likelihood that they are related to the index trauma (definite; probable; unlikely).
Time frame: Pre (week 0), mid (week 4), and post intervention (week 10).
Secondary
PTSD Symptoms 1
Measured by a self-report questionnaire: the PTSD Symptom Checklist (PCL). Scores range from 0-4 and higher scores indicate more severe PTSD symptoms.
Time frame: Pre (week 0), mid (week 4), and post intervention (week 10).