- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus 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.
Tutkimuksen yleiskatsaus
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskelupaikat
-
-
New York
-
Syracuse, New York, Yhdysvallat, 13210
- Syracuse VA Medical Center, Syracuse, NY
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
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
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Tukevaa hoitoa
- Jako: Satunnaistettu
- Inventiomalli: Yksittäinen ryhmätehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: 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.
|
Veterans Health Administration variation of integrative health coaching.
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Goal Attainment Scaling (GAS)
Aikaikkuna: Participants completed GAS twice weekly throughout the entire 24 week study period and scores were compared over time.
|
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.
|
Participants completed GAS twice weekly throughout the entire 24 week study period and scores were compared over time.
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
PTSD Checklist for DSM-5 (PCL-5)
Aikaikkuna: 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.
|
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.
|
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.
|
|
Inventory of Psychosocial Functioning (IPF)
Aikaikkuna: Participants completed the IPF at baseline, pre-treatment, post-treatment, and final follow-up assessments over the course of the 24 week study period.
|
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.
|
Participants completed the IPF at baseline, pre-treatment, post-treatment, and final follow-up assessments over the course of the 24 week study period.
|
|
Client Satisfaction Questionnaire
Aikaikkuna: 8 weeks following intervention onset
|
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.
|
8 weeks following intervention onset
|
Yhteistyökumppanit ja tutkijat
Yhteistyökumppanit
Tutkijat
- Päätutkija: Emily Johnson, PhD, Syracuse VA Medical Center, Syracuse, NY
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muut tutkimustunnusnumerot
- D2476-M
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Yhdysvalloissa valmistettu ja sieltä viety tuote
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .
Kliiniset tutkimukset PTSD
-
University of PittsburghValmisPTSD | Ei PTSDYhdysvallat
-
Acacia ClinicsElectroCore INC; Vagus Nerve SocietyRekrytointiPTSD | Posttraumaattinen stressihäiriö | Posttraumaattiset stressihäiriöt | Posttraumaattinen stressihäiriö (PTSD) | Posttraumaattinen stressihäiriö PTSD | PTSD - posttraumaattinen stressihäiriö | Posttraumaattinen stressihäiriö, PTSDYhdysvallat
-
COMPASS PathwaysEi vielä rekrytointiaPTSD | PTSD, posttraumaattinen stressihäiriö | PTSD-oireet | PTSD - posttraumaattinen stressihäiriö
-
Region ÖstergötlandValmisPTSD | PTSD (synnytykseen liittyvä) | Posttraumaattinen stressi | PTSD - posttraumaattinen stressihäiriö | Synnytykseen liittyvä PTSDRuotsi
-
Imperial College Healthcare NHS TrustImperial College LondonRekrytointiPTSDYhdistynyt kuningaskunta
-
VA Office of Research and DevelopmentSan Diego Veterans Healthcare SystemValmis
-
University of Wisconsin, MadisonNational Institute of Mental Health (NIMH)Valmis
-
VA Office of Research and DevelopmentValmis
-
Oregon Health and Science UniversityNational Center for Advancing Translational Sciences (NCATS); Oregon Clinical...Lopetettu
-
Creighton UniversityValmis
Kliiniset tutkimukset Whole Health Coaching
-
War Related Illness and Injury Study CenterValmisMonimutkaiset terveysongelmatYhdysvallat
-
Scripps Whittier Diabetes InstituteSan Diego State UniversityValmisTyypin 2 diabetes (T2DM)Yhdysvallat
-
Pack HealthGlaxoSmithKline; University of WashingtonRekrytointiMultippeli myelooma | Uusiutunut hematologinen pahanlaatuisuusYhdysvallat
-
Scott & White Health PlanValmis
-
Centers for Disease Control and PreventionUniversity of California, San Francisco; California Department of Health...ValmisSydän-ja verisuonitaudit | Krooniset sairaudet
-
University of ArizonaNational Heart, Lung, and Blood Institute (NHLBI)Ilmoittautuminen kutsustaUnihäiriöt, luontaiset | Nukkumisen alkamis- ja ylläpitohäiriöt | Unenpuute | Kognitiivinen käyttäytymisterapiaYhdysvallat
-
VA Office of Research and DevelopmentRekrytointi
-
Vanderbilt UniversityVanderbilt University Medical CenterRekrytointiKehon painon muutokset | Lihavuus, Lapsuus | Ruokavalio, TerveYhdysvallat
-
Ottawa Hospital Research InstituteUniversity of Ottawa; Canadian Anesthesiologists' SocietyRekrytointiLoppuun palaminen | Ahdistus, EmotionaalinenKanada
-
Good Samaritan Hospital Medical Center, New YorkTuntematonMetastaattinen aivosyöpäYhdysvallat