- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03364192
Peer-Delivered Whole Health Coaching for Veterans With PTSD
Peer-Delivered Whole Health Coaching to Improve Recovery in Veterans With PTSD
The investigators are evaluating a service called peer-delivered Whole Health Coaching to understand how it can help Veterans with PTSD. This project has two main goals: (1) determine how peer-delivered Whole Health Coaching can help Veterans with post-traumatic stress disorder and (2) learning about feasibility of implementing this service in Veterans Health Administration primary care settings. The investigators are also evaluating feasibility of the research methods in this trial to learn how to improve future studies on this topic.
Whole Health Coaching is a service designed to improve health and wellness. It is a variation of integrative health coaching and is being used in Veterans Health Administration medical centers. In Whole Health Coaching, Veterans will work with coaches to develop a personal health mission, develop specific goals and action steps, and then adjust their plan as needed. Coaches provide guidance and support throughout the process. In this project, a peer support specialist working in primary care will be the coach. VA Peer Support Specialists, "peers", are Veterans recovering from a mental health condition trained to help other Veterans improve their health.
All participants will receive peer-delivered Whole Health Coaching. Participants will be randomly assigned a start date for their first session with the Peer Whole Health Coach between 4 and 13 weeks after they start the study. The information provided during this time prior to the first session helps us understand how participants do on their own without the service. The research components include interviews and questionnaires about health and wellness, goals, and experiences with the service. Veterans who participate in the study will complete short questionnaires twice a week for 6 months and have four longer appointments where more questions will be asked. Participants will also be given the opportunity to provide feedback on the service.
Study Overview
Detailed Description
The investigators are evaluating a service called peer-delivered Whole Health Coaching to understand how it can help Veterans with PTSD. This project has two main goals: (1) determine how peer-delivered Whole Health Coaching can help Veterans with post-traumatic stress disorder and (2) learning about feasibility of implementing this service in Veterans Health Administration primary care settings. The investigators are also evaluating feasibility of the research methods in this trial to learn how to improve future studies on this topic.
Whole Health Coaching is a service designed to improve health and wellness. It is a variation of integrative health coaching and is being used in Veterans Health Administration medical centers. In Whole Health Coaching, Veterans will work with coaches to develop a personal health mission, develop specific goals and action steps, and then adjust their plan as needed. Coaches provide guidance and support throughout the process. In this project, a peer support specialist working in primary care will be the coach. VA Peer Support Specialists, "peers", are Veterans recovering from a mental health condition trained to help other Veterans improve their health.
All participants will receive peer-delivered Whole Health Coaching. Participants will be randomly assigned a start date for their first session with the Peer Whole Health Coach between 4 and 13 weeks after they start the study. The information provided during this time prior to the first session helps us understand how participants do on their own without the service. The research components include interviews and questionnaires about health and wellness, goals, and experiences with the service. Veterans who participate in the study will complete short questionnaires twice a week for 6 months and have four longer appointments where more questions will be asked. Participants will also be given the opportunity to provide feedback on the service.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New York
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Syracuse, New York, United States, 13210
- Syracuse VA Medical Center, Syracuse, NY
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Veteran status
- Enrolled in primary care at the Syracuse VA (and affiliated CBOCs) and seen in primary care within the past year
- Probable PTSD defined as screening positive for a Criterion A event and PTSD Checklist for DSM-5 (PCL-5) score 33
Exclusion Criteria:
- Unable to communicate in spoken and written English
- Gross cognitive impairment
- Current symptoms of mania/psychosis
- At risk for suicide
- Engaged in psychotherapy in a non-primary care setting
- Changes to psychotropic medications for PTSD within the last 2 months
- Preference for direct referral to specialty mental healthcare
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Peer-delivered Whole Health Coaching
Whole Health Coaching is a Veterans Health Administration variation of integrative health coaching.
For this study it will be administered by a peer support specialist.
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Veterans Health Administration variation of integrative health coaching.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Goal Attainment Scaling (GAS)
Time Frame: Participants completed GAS twice weekly throughout the entire 24 week study period and scores were compared over time.
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Goal Attainment Scaling (GAS) is a systematic method used to evaluate participants' individualized goals and progress towards Whole Health goals.
Scores range from 0-10 for each domain of whole health measured with higher scores indicating more positive outcomes.
Each participant's GAS score reflects the GAS score from the goal domain(s) that the participant identified as primary during the course of the intervention.
For participants with multiple goals, GAS scores were average across domains.
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Participants completed GAS twice weekly throughout the entire 24 week study period and scores were compared over time.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PTSD Checklist for DSM-5 (PCL-5)
Time Frame: Participants completed the PCL-5 at baseline, pre-treatment, post-treatment, and final follow-up assessments over the course of the 24 week study period.
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The PTSD Checklist for DSM-5 (PCL-5) is a measure of participants' PTSD symptoms.
The total sum score ranges from 0-80 with lower scores indicating more positive outcomes.
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Participants completed the PCL-5 at baseline, pre-treatment, post-treatment, and final follow-up assessments over the course of the 24 week study period.
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Inventory of Psychosocial Functioning (IPF)
Time Frame: Participants completed the IPF at baseline, pre-treatment, post-treatment, and final follow-up assessments over the course of the 24 week study period.
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The Inventory of Psychosocial Functioning (IPF) is a measure of psychosocial functioning across several domains.
The total score was used for this project and reflects a composite of multiple subscales (romantic relationships, family, work, friendships and socializing, parenting, education, and self care).
Scores range from 0-100 with lower scores indicating more positive outcomes.
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Participants completed the IPF at baseline, pre-treatment, post-treatment, and final follow-up assessments over the course of the 24 week study period.
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Client Satisfaction Questionnaire
Time Frame: 8 weeks following intervention onset
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Measure of participants' satisfaction with the peer-delivered Whole Health Coaching service.
CSQ-8 scores range from 8-32 with higher values indicating more positive outcomes.
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8 weeks following intervention onset
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Emily Johnson, PhD, Syracuse VA Medical Center, Syracuse, NY
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- D2476-M
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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