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.
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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New York
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Syracuse、New York、アメリカ、13210
- Syracuse VA Medical Center, Syracuse, NY
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Goal Attainment Scaling (GAS)
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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PTSD Checklist for DSM-5 (PCL-5)
時間枠：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)
時間枠：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
時間枠：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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協力者と研究者
捜査官
- 主任研究者：Emily Johnson, PhD、Syracuse VA Medical Center, Syracuse, NY
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- D2476-M
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
PTSDの臨床試験
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Imperial College Healthcare NHS TrustImperial College London募集
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VA Office of Research and DevelopmentUniversity of California, San Diego募集
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University of Wisconsin, MadisonNational Institute of Mental Health (NIMH)積極的、募集していない
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Oregon Health and Science University招待による登録
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VA Office of Research and DevelopmentPortland VA Medical Center積極的、募集していない
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VA Office of Research and DevelopmentSan Diego Veterans Healthcare System完了
Whole Health Coachingの臨床試験
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San Francisco Veterans Affairs Medical Center募集
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Boston Children's HospitalUnited States Department of Defense; National Football League完了
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Johns Hopkins UniversityApple Inc.; iHealth完了
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University of Texas Southwestern Medical CenterVivify Health引きこもった
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Massachusetts General HospitalDenver Health and Hospital Authority; Prisma Health-Upstate完了