Enhancing Delivery of Problem Solving Therapy Using SmartPhone Technology
Visão geral do estudo
Status
Status
Condições
Condições
Intervenção / Tratamento
Intervenção / Tratamento
Descrição detalhada
Tipo de estudo
Tipo de estudo
Inscrição (Real)
Inscrição
Estágio
Estágio
- Fase 2
- Fase 1
Contactos e Locais
Locais de estudo
-
-
Arkansas
-
No. Little Rock, Arkansas, Estados Unidos, 72114-1706
- Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
-
-
Critérios de participação
Critérios de elegibilidade
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Veterans will be eligible if they are 18 years old or older,
- speak and understand English,
- are patients in the Central Arkansas Veterans Healthcare System Primary Care-Mental Health Integration,
and have a current diagnosis of depression
- major depressive disorder, 296.2x and 296.3x
- dysthymic disorder, 300.4
- depressive disorder not otherwise specified, 311
and/or anxiety
- panic disorder without agoraphobia, 300.01
- panic disorder with agoraphobia, 300.21
- specific phobia, 300.29
- social phobia, 300.23
- obsessive-compulsive disorder; 300.3
- posttraumatic stress disorder, 309.81
- acute stress disorder, 308.3
- generalized anxiety disorder, 300.02
- anxiety disorder not otherwise specified, 300.00
- We considered enrolling only those Veterans diagnosed with mild-to-moderate depression, but chose to include a range of anxiety and depression-related disorders in order to reflect the population of Veterans seen in Primary Care-Mental Health Integration.
- Additionally, Problem Solving Therapy is designed to treat a range of stress-related problems, including both anxiety and depressive disorders.
- Veterans taking prescribed anxiolytics or anti-depressants will be eligible if they are on a stable medication regimen.
Exclusion Criteria:
- Exclusionary criteria include any current suicidal ideation,
- substance dependence diagnosis and current use,
- any psychotic spectrum diagnoses or
- inability to provide informed consent.
- Diagnosis will be confirmed by chart review and Mini International Neuropsychiatric Interview.
- Acute suicidal ideation will be determined by the assessing or treating clinician.
- During the baseline and follow-up interviews, any Veteran who endorses a "1" or higher on item # 21 on the Depression Anxiety and Stress Scale "I feel that life isn't worthwhile" or item # 9 on the Patient Health Questionnaire-9 "thoughts that you would be better off dead or of hurting yourself" will be asked follow-up questions on the suicide risk protocol (see appendix 3).
- Current substance or alcohol use will be determined by the alcohol and substance use modules of the Mini International Neuropsychiatric Interview.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Pesquisa de serviços de saúde
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Número de braços
Armas e Intervenções
Grupo de Participantes / BraçoGrupo de Participantes / Braço |
Intervenção / TratamentoIntervenção / Tratamento |
|---|---|
|
Experimental: Problem Solving Therapy plus Moving Forward (PST-MF)
All Veterans will receive a standard 6-session administration of Problem Solving Therapy (Nezu & D'Zurilla, 1999).
Session 1 will take place in-person during a scheduled appointment and will last for 1 hour.
Subsequent sessions will take place over the telephone and will last for approximately 30 minutes.
Participants in this arm will also receive the Moving Forward app for SmartPhones, which was adapted from Problem Solving Therapy to be used either as a standalone treatment or as an adjunct to other related therapies such as in-person Problem Solving Therapy or the Moving Forward website.
The phone content matches Problem Solving Therapy.
Benefits of the app include 24-hours accessibility of psychoeducational materials and worksheets.
|
All Veterans will receive a standard 6-session administration of Problem Solving Therapy (Nezu & D'Zurilla, 1999).
Session 1 will take place in-person during a scheduled appointment and will last for 1 hour.
Subsequent sessions will take place over the telephone and will last for approximately 30 minutes.
Participants in this arm will also receive the Moving Forward app for SmartPhones, which was adapted from Problem Solving Therapy to be used either as a standalone treatment or as an adjunct to other related therapies such as in-person Problem Solving Therapy or the Moving Forward website.
The phone content matches Problem Solving Therapy.
Benefits of the app include 24-hours accessibility of psychoeducational materials and worksheets.
|
|
Comparador Ativo: Problem Solving Therapy
All Veterans will receive a standard 6-session administration of Problem Solving Therapy (Nezu & D'Zurilla, 1999).
Session 1 will take place in-person during a scheduled appointment and will last for 1 hour.
Subsequent sessions will take place over the telephone and will last for approximately 30 minutes.
|
All Veterans will receive a standard 6-session administration of Problem Solving Therapy (Nezu & D'Zurilla, 1999).
Session 1 will take place in-person during a scheduled appointment and will last for 1 hour.
Subsequent sessions will take place over the telephone and will last for approximately 30 minutes.
|
O que o estudo está medindo?
Medidas de resultados primários
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Depression Anxiety and Stress Scale (DASS)
Prazo: 6 weeks, 12 weeks
|
The 7-item depression subscale on the Depression Anxiety and Stress Scale (DASS) is measured on a 0-42 scale.
Higher scores represent worse depression symptoms.
The 7-item anxiety subscale on the Depression Anxiety and Stress Scale (DASS) is measured on a 0-42 scale.
Higher scores represent worse anxiety symptoms.
The 7-item stress subscale on the Depression Anxiety and Stress Scale (DASS) is measured on a 0-42 scale.
Higher scores represent worse stress symptoms.
|
6 weeks, 12 weeks
|
Medidas de resultados secundários
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Short Form Health Survey-12-Veterans (SF-12 V) Mental Composite Score
Prazo: 6 weeks, 12 weeks
|
The 12-item Short Form Health Survey-12-Veterans (SF-12 V) Mental Composite Score is rated on a 0-100 scale.
Higher scores represent better mental health functioning.
|
6 weeks, 12 weeks
|
|
Client Satisfaction Questionnaire (CSQ-8)
Prazo: 6 weeks
|
The 8-item Client Satisfaction Questionnaire (CSQ-8) is rated on an 8-32 scale.
Higher scores represent greater satisfaction with the intervention.
|
6 weeks
|
Colaboradores e Investigadores
Patrocinador
Patrocinador
Investigadores
Investigadores
- Investigador principal: Kathleen M Grubbs, PhD, Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Início do estudo
Conclusão Primária (Real)
Conclusão Primária
Conclusão do estudo (Real)
Conclusão do estudo
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Primeira postagem
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última Atualização Postada
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
Outros números de identificação do estudo
- PPO 13-122
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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 .