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| ID | Type | Description | Link |
|---|---|---|---|
| 5R34AT009678-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Primary Care Brief Mindfulness Training | Experimental | group-based mindfulness training |
|
| PTSD Psychoeducational Class | Active Comparator | group-based psychoeducation class |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Primary Care Brief Mindfulness Training | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Assessment Retention Assessment Retention | rate of participants who complete all assessment time points | enrollment to 24 week follow-up |
| Intervention Retention | rate of participants who complete assigned intervention | enrollment to 24 week follow-up |
| 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. | enrollment to 8 week follow-up |
| Client Satisfaction Scale | measured by the Client Satisfaction Questionnaire, scale range 1-32 with 32 indicating highest satisfaction. | 8 week follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Post-traumatic Stress Checklist for DSM-5 | PTSD Checklist-5. Scale range 0-63 with 63 indicating highest PTSD severity. | 24 week follow-up |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kyle Possemato, Ph.D. | VA Center for Intergrated Healthcare | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Syracuse Veterans Affairs Medical Center | Syracuse | New York | 13210 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36576365 | Derived | Possemato K, Bergen-Cico D, Buckheit K, Ramon A, McKenzie S, Smith AR, Wade M, Beehler GP, Pigeon WR. Randomized Clinical Trial of Brief Primary Care-Based Mindfulness Training Versus a Psychoeducational Group for Veterans With Posttraumatic Stress Disorder. J Clin Psychiatry. 2022 Dec 28;84(1):22m14510. doi: 10.4088/JCP.22m14510. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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." |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| 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, Categorical | Count of Participants |
| 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 | Number of Participants With Assessment Retention Assessment Retention | rate of participants who complete all assessment time points | Posted | Count of Participants | Participants | enrollment to 24 week follow-up |
|
enrollment to 24 weeks
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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 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ER visit or hospitalization unrelated to study interventions | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kyle Possemato | VA Center for Integrated Heathcare | 315-425-4400 | 53551 | kyle.possemato@va.gov |
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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 | Oct 25, 2022 | Oct 26, 2022 | 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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|
| PTSD Psychoeducational Class | Behavioral | 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." |
|
| 24 week follow-up |
| Patient Health Questionnaire-9, | Patient Health Questionnaire-9, range 0-27, with 27 indicating the greatest amount of depression. | 24 week follow-up |
| Self Compassion Scale- Short Form | Self Compassion Scale- Short Form, range 0-60, with 60 indicating the greatest amount of self compassion. | 8 week post-treatment |
| 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. | 24 week follow-up |
| BG001 |
| 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." |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Primary | Intervention Retention | rate of participants who complete assigned intervention | Posted | Count of Participants | Participants | enrollment to 24 week follow-up |
|
|
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| 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. | Data were not collected for the "PTSD Psychoeducational Class Arm/ Group" | Posted | Number | number of essential components delivered | enrollment to 8 week follow-up |
|
|
|
| Primary | Client Satisfaction Scale | measured by the Client Satisfaction Questionnaire, scale range 1-32 with 32 indicating highest satisfaction. | Posted | Mean | Standard Deviation | units on a scale | 8 week follow-up |
|
|
|
| Secondary | Post-traumatic Stress Checklist for DSM-5 | PTSD Checklist-5. Scale range 0-63 with 63 indicating highest PTSD severity. | Posted | Mean | Standard Error | score on a scale | 24 week follow-up |
|
|
|
| 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. | Posted | Mean | Standard Error | score on a scale | 24 week follow-up |
|
|
|
| Secondary | Patient Health Questionnaire-9, | Patient Health Questionnaire-9, range 0-27, with 27 indicating the greatest amount of depression. | Posted | Mean | Standard Error | score on a scale | 24 week follow-up |
|
|
|
| Secondary | Self Compassion Scale- Short Form | Self Compassion Scale- Short Form, range 0-60, with 60 indicating the greatest amount of self compassion. | Posted | Mean | Standard Error | score on a scale | 8 week post-treatment |
|
|
|
| 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. | Posted | Mean | Standard Error | score on a scale | 24 week follow-up |
|
|
|
| 0 |
| 27 |
| 3 |
| 27 |
| 0 |
| 27 |
| EG001 | 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." | 0 | 25 | 4 | 25 | 0 | 25 |
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