Post-traumatic Stress Disorder
Conditions
Brief summary
The proposed study supports a line of research that seeks to improve the health of military veterans with post-traumatic stress disorder (PTSD) by teaching them mindfulness skills. The proposed study first gathers Veteran's Affairs mental health provider and peer support specialist feedback to adapt a brief mindfulness intervention and then investigates the feasibility of testing this intervention in a small randomized clinical trial. The study targets primary care patients with PTSD who may be reluctant to engage in other mental health treatments and provides them with mindfulness training to reduce PTSD symptoms, improve psychosocial functioning and increase hope for recovery.
Detailed description
Posttraumatic Stress Disorder (PTSD) is highly prevalent in Veterans Affairs (VA) primary care patients (\ 11.5%) and is associated with significant functional impairment, compromised health, and economic costs. While effective psychotherapies for PTSD are available in VA specialty mental health care settings, primary care patients do not routinely engage in or complete these specialty services. Therefore, alternative delivery models are needed. This proposal integrates two lines of research: mindfulness training and peer support services to test a low-stigma intervention in primary care: Primary Care Based Mindfulness Training (PCBMT). Brief mindfulness training focuses on skill acquisition to help patients manage distress and can serve as a gateway to more intensive treatments for Veterans who are not yet willing to discuss their trauma histories. Peer support specialists help shift treatment away from the medical model focused on symptom reduction to a recovery model focused on leading a meaningful, purposeful life, with or without ongoing illness. This proposal aims to refine our existing PCBMT to be co-delivered by VA mental health providers and peers and then test important aspects of feasibility to prepare for a future full-scale pragmatic clinical trial. First, VA providers and peers will participate in PCBMT led by study investigators who are certified Mindfulness Based Stress Reduction (MBSR) instructors. Next, study staff will gather feedback from the trained providers and peers for further adaptation and implementation. After this, providers and peers interested in being trained as PCBMT interventionists will be trained by study investigators. Finally, a pilot RCT will be conducted. Both treatments conditions will consist of four, 90-minute group sessions co-facilitated by a VA provider and Veteran peer. The long-term goal of this research is to improve clinical and personal recovery outcomes for Veterans with PTSD. Our immediate goals are to refine PCBMT based on Veteran, provider, and peer feedback then test the methods needed to conduct a future full-scale RCT, in accordance with the following aims: 1. Gather VA mental health provider (n=5) and peer (n=5) feedback to refine PCBMT to a) ensure successful implementation in the VA setting (including creation of a provider manual and standardized provider/peer training curriculum) and b) maximize Veteran skill development to aid in future participation of evidence-based treatment for PTSD. 2. Assess the feasibility of conducting a pilot RCT (N=60) comparing PCBMT to a PTSD psychoeducation group on a) rates of recruitment and study retention, b) participant adherence and retention in treatment, provider and peer treatment fidelity, c) participant acceptability (satisfaction, perceived helpfulness) in PCBMT and control condition, and d) measuring outcomes of interest for the future larger trial including: PTSD severity, psychosocial functioning, recovery orientation, active engagement in mental health care.
Interventions
BEHAVIORALPrimary Care Brief Mindfulness Training
Primary Care Brief Mindfulness Training consists of four 90-minute group classes that teach sitting meditation, body scan, moving meditation, gentle yoga, and group discussion on topics such as non-judging, patience, trust, non-striving, acceptance, and letting go.
BEHAVIORALPTSD Psychoeducational Class
The PTSD Psychoeducational Class is designed to provide a supportive environment for learning about PTSD-related issues and to help Veterans determine what recovery strategies will be most helpful for them. Session themes include Civilian Readjustment and PTSD, Trust, Safety, and Healing and Treatment Strategies.
Sponsors
National Institutes of Health (NIH)
National Center for Complementary and Integrative Health (NCCIH)
Syracuse VA Medical Center
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
1. enrolled in services at the Syracuse or Canandaigua VAMC and 2. report significant PTSD symptoms (qualifying criterion A traumatic event plus at least a 31 on the PCL-5).
Exclusion criteria
1. gross cognitive impairment (\>16 on the Blessed OMC), 2. suicide attempt or desire to commit suicide in the last month (as measured by P4 screener). 3. have received psychotherapy or change in psychiatric medication outside of VHA primary care in the last 2 months. 4. voice a preference to be directly referred to specialty mental health care.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Assessment Retention Assessment Retention | enrollment to 24 week follow-up | rate of participants who complete all assessment time points |
| Intervention Retention | enrollment to 24 week follow-up | rate of participants who complete assigned intervention |
| Primary Care Brief Mindfulness Fidelity Assessment | enrollment to 8 week follow-up | Number of essential components of the Primary Care Brief Mindfulness Training curriculum delivered across all 5 cohorts of PCBMT. Number of essential components 0-90. Higher scores indicate more components delivered and better fidelity. |
| Client Satisfaction Scale | 8 week follow-up | measured by the Client Satisfaction Questionnaire, scale range 1-32 with 32 indicating highest satisfaction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-traumatic Stress Checklist for DSM-5 | 24 week follow-up | PTSD Checklist-5. Scale range 0-63 with 63 indicating highest PTSD severity. |
| Recovery Orientation Scale- 24 | 24 week follow-up | Recovery Orientation Scale-24 measuring recovery from mental health concerns. Range 24-120, with 120 indicating the greatest amount of recovery. |
| Patient Health Questionnaire-9, | 24 week follow-up | Patient Health Questionnaire-9, range 0-27, with 27 indicating the greatest amount of depression. |
| Self Compassion Scale- Short Form | 8 week post-treatment | Self Compassion Scale- Short Form, range 0-60, with 60 indicating the greatest amount of self compassion. |
| Health Promoting Lifestyle Profile II: Health Responsibility Subscale | 24 week follow-up | Health Promoting Lifestyle Profile II: Health Responsibility. Subscale ranges from 9-36, with 36 indicating the most health responsibility. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Primary Care Brief Mindfulness Training Primary Care Brief Mindfulness Training: Primary Care Brief Mindfulness Training consists of four 90-minute group classes that teach sitting meditation, body scan, moving meditation, gentle yoga, and group discussion on topics such as non-judging, patience, trust, non-striving, acceptance, and letting go. | 28 |
| PTSD Psychoeducational Class PTSD Psychoeducational Class: The PTSD Psychoeducational Class is designed to provide a supportive environment for learning about PTSD-related issues and to help Veterans determine what recovery strategies will be most helpful for them. Session themes include Civilian Readjustment and PTSD, Trust, Safety, and Healing and Treatment Strategies. | 27 |
| Total | 55 |
Baseline characteristics
| Characteristic | Primary Care Brief Mindfulness Training | PTSD Psychoeducational Class | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 12 Participants | 11 Participants | 23 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants | 16 Participants | 32 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 2 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 27 Participants | 25 Participants | 52 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 26 Participants | 21 Participants | 47 Participants |
| Sex: Female, Male Female | 4 Participants | 3 Participants | 7 Participants |
| Sex: Female, Male Male | 24 Participants | 24 Participants | 48 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 27 | 0 / 25 |
| other Total, other adverse events | 0 / 27 | 0 / 25 |
| serious Total, serious adverse events | 3 / 27 | 4 / 25 |
Outcome results
Primary
Client Satisfaction Scale
measured by the Client Satisfaction Questionnaire, scale range 1-32 with 32 indicating highest satisfaction.
Time frame: 8 week follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Primary Care Brief Mindfulness Training | Client Satisfaction Scale | 19.07 units on a scale | Standard Deviation 1.174 |
| PTSD Psychoeducational Class | Client Satisfaction Scale | 19.36 units on a scale | Standard Deviation 1.287 |
Primary
Intervention Retention
rate of participants who complete assigned intervention
Time frame: enrollment to 24 week follow-up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Primary Care Brief Mindfulness Training | Intervention Retention | 21 Participants |
| PTSD Psychoeducational Class | Intervention Retention | 20 Participants |
Primary
Number of Participants With Assessment Retention Assessment Retention
rate of participants who complete all assessment time points
Time frame: enrollment to 24 week follow-up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Primary Care Brief Mindfulness Training | Number of Participants With Assessment Retention Assessment Retention | 24 Participants |
| PTSD Psychoeducational Class | Number of Participants With Assessment Retention Assessment Retention | 25 Participants |
Primary
Primary Care Brief Mindfulness Fidelity Assessment
Number of essential components of the Primary Care Brief Mindfulness Training curriculum delivered across all 5 cohorts of PCBMT. Number of essential components 0-90. Higher scores indicate more components delivered and better fidelity.
Time frame: enrollment to 8 week follow-up
Population: Data were not collected for the PTSD Psychoeducational Class Arm/ Group
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Primary Care Brief Mindfulness Training | Primary Care Brief Mindfulness Fidelity Assessment | 85 number of essential components delivered |
Secondary
Health Promoting Lifestyle Profile II: Health Responsibility Subscale
Health Promoting Lifestyle Profile II: Health Responsibility. Subscale ranges from 9-36, with 36 indicating the most health responsibility.
Time frame: 24 week follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Primary Care Brief Mindfulness Training | Health Promoting Lifestyle Profile II: Health Responsibility Subscale | 24.80 score on a scale | Standard Error 1 |
| PTSD Psychoeducational Class | Health Promoting Lifestyle Profile II: Health Responsibility Subscale | 21.40 score on a scale | Standard Error 1 |
Secondary
Patient Health Questionnaire-9,
Patient Health Questionnaire-9, range 0-27, with 27 indicating the greatest amount of depression.
Time frame: 24 week follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Primary Care Brief Mindfulness Training | Patient Health Questionnaire-9, | 9.12 score on a scale | Standard Error 1.21 |
| PTSD Psychoeducational Class | Patient Health Questionnaire-9, | 12.98 score on a scale | Standard Error 1.21 |
Secondary
Post-traumatic Stress Checklist for DSM-5
PTSD Checklist-5. Scale range 0-63 with 63 indicating highest PTSD severity.
Time frame: 24 week follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Primary Care Brief Mindfulness Training | Post-traumatic Stress Checklist for DSM-5 | 32.99 score on a scale | Standard Error 3.27 |
| PTSD Psychoeducational Class | Post-traumatic Stress Checklist for DSM-5 | 40.89 score on a scale | Standard Error 3.29 |
Secondary
Recovery Orientation Scale- 24
Recovery Orientation Scale-24 measuring recovery from mental health concerns. Range 24-120, with 120 indicating the greatest amount of recovery.
Time frame: 24 week follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Primary Care Brief Mindfulness Training | Recovery Orientation Scale- 24 | 89.53 score on a scale | Standard Error 2.88 |
| PTSD Psychoeducational Class | Recovery Orientation Scale- 24 | 82.35 score on a scale | Standard Error 2.9 |
Secondary
Self Compassion Scale- Short Form
Self Compassion Scale- Short Form, range 0-60, with 60 indicating the greatest amount of self compassion.
Time frame: 8 week post-treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Primary Care Brief Mindfulness Training | Self Compassion Scale- Short Form | 32.38 score on a scale | Standard Error 1.4 |
| PTSD Psychoeducational Class | Self Compassion Scale- Short Form | 34.34 score on a scale | Standard Error 1.98 |