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Peer-Delivered Whole Health Coaching for Veterans With PTSD

23 november 2020 bijgewerkt door: VA Office of Research and Development

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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

28

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • New York
      • Syracuse, New York, Verenigde Staten, 13210
        • Syracuse VA Medical Center, Syracuse, NY

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Gedragsmatig: Whole Health Coaching
Veterans Health Administration variation of integrative health coaching.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Goal Attainment Scaling (GAS)
Tijdsspanne: 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.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
PTSD Checklist for DSM-5 (PCL-5)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

VA Office of Research and Development

Medewerkers

US Department of Veterans Affairs

Onderzoekers

  • Hoofdonderzoeker: Emily Johnson, PhD, Syracuse VA Medical Center, Syracuse, NY

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 mei 2018

Primaire voltooiing (Werkelijk)

31 oktober 2019

Studie voltooiing (Werkelijk)

31 oktober 2019

Studieregistratiedata

Eerst ingediend

30 november 2017

Eerst ingediend dat voldeed aan de QC-criteria

30 november 2017

Eerst geplaatst (Werkelijk)

6 december 2017

Updates van studierecords

Laatste update geplaatst (Werkelijk)

21 december 2020

Laatste update ingediend die voldeed aan QC-criteria

23 november 2020

Laatst geverifieerd

1 november 2020

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • D2476-M

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Klinische onderzoeken op PTSS

Klinische onderzoeken op Whole Health Coaching

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