- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico 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.
Visão geral do estudo
Descrição detalhada
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.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
New York
-
Syracuse, New York, Estados Unidos, 13210
- Syracuse VA Medical Center, Syracuse, NY
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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.
|
Veterans Health Administration variation of integrative health coaching.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Goal Attainment Scaling (GAS)
Prazo: 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.
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
PTSD Checklist for DSM-5 (PCL-5)
Prazo: 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)
Prazo: 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
Prazo: 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
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Emily Johnson, PhD, Syracuse VA Medical Center, Syracuse, NY
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- D2476-M
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
produto fabricado e exportado dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
Ensaios clínicos em TEPT
-
Region ÖstergötlandConcluídoTEPT | PTSD (relacionado ao parto) | Estresse pós-traumático | TEPT - Transtorno de Estresse Pós-Traumático | PTSD relacionado ao partoSuécia
-
VA Office of Research and DevelopmentAinda não está recrutando
-
Stanford UniversityNational Center for Complementary and Integrative Health (NCCIH); University...RecrutamentoCuidados pós-parto | Terapia de Exposição Escrita | PTSD (relacionado ao parto) | Técnicas de respiraçãoEstados Unidos
-
Indiana UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development...RecrutamentoPTSD (relacionado ao parto) | TEPT - Transtorno de Estresse Pós-TraumáticoEstados Unidos
-
University of BirminghamBlack Country Healthcare NHS Foundation TrustRecrutamentoColagem | PTSD (relacionado ao parto) | Bem-estar psicológicoReino Unido
-
Stanford UniversityAinda não está recrutandoAborto | Natimorto | PTSD (relacionado ao parto) | Luto (luto traumático e luto existencial)Estados Unidos
-
Massachusetts General HospitalRecrutamentoPTSD (relacionado ao parto)Estados Unidos
-
Region ÖstergötlandConcluídoTEPT | Transtorno de Estresse Pós-Traumático | Medo do parto | Tristeza pós parto | Depressão pós Natal | PTSD relacionado ao partoSuécia
-
The University of Hong KongRecrutamentoIdeação Suicida | Síndrome do pânico | Ataque de pânico | Transtorno Depressivo Maior (TDM) | Transtorno Bipolar I | Transtorno do Uso de Álcool (AUD) | Transtorno Bipolar II | Transtorno de Estresse Pós-Traumático (TEPT) | Episódio maníaco | Transtorno Obsessivo-Compulsivo (TOC) | Transtorno por Uso de Substâncias... e outras condiçõesHong Kong
Ensaios clínicos em Whole Health Coaching
-
Chinese University of Hong KongRecrutamentoDor musculoesquelética | Dor crônica | Tratamento da dor | MusculoesqueléticoHong Kong
-
University of California, San FranciscoConcluídoMieloma múltiploEstados Unidos
-
Pack HealthGlaxoSmithKline; University of WashingtonRecrutamentoMieloma múltiplo | Malignidade Hematológica RecidivanteEstados Unidos
-
Scott & White Health PlanConcluído
-
Aga Khan UniversityRecrutamentoDesnutrição, Criança | Desnutrição InfantilPaquistão
-
University of California, San FranciscoAmerican Society of Clinical OncologyConcluídoMieloma múltiplo | Transplante de Células TroncoEstados Unidos
-
Harvard Pilgrim Health CareCenters for Disease Control and Prevention; Harvard School of Public Health...ConcluídoObesidadeCanadá, Estados Unidos
-
The Institute for Functional MedicineFunctional Medicine Coaching AcademyConcluído
-
The Miriam HospitalNational Institute on Alcohol Abuse and Alcoholism (NIAAA)Ainda não está recrutandoBeber álcoolEstados Unidos
-
University of Colorado, DenverNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); University...ConcluídoDiabetes Mellitus, Tipo 2Estados Unidos