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Augmented Depression Therapy (ADepT) Case Series

28 de julho de 2026 atualizado por: Jay Fournier, Ohio State University

This research study plans to examine the use of Augmented Depression Therapy (ADepT) in order to evaluate what patients think about ADepT and how well it works. ADepT is a type of therapy that builds wellbeing and is being provided to you as standard of care.

ADepT treatment consists of 15 therapy sessions (typically provided weekly) with each session lasting around 60 minutes. Following these sessions, you can receive five optional booster sessions over the next 12 months with each of these lasting around 60 minutes. Ultimately, the timing and duration of these sessions will be determined between you and your provider and scheduled accordingly.

As part of this study you will be randomized (randomly assigned) to different research assessment lengths before the start of treatment and then will complete assessments for the 12 months following the end of the weekly portion of ADepT treatment. The length of your participation will be between 70 weeks to 82 weeks.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

40

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

  • Estados Unidos
    • Ohio
      • Columbus, Ohio, Estados Unidos, 43214
        • The Ohio State University Wexner Medical Center
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

Inclusion Criteria:

  1. Aged 18 -65
  2. Currently experiencing a major depressive episode based on the Quick Structured Clinical Interview for DSM-5 Disorders (QuickSCID-5; First & Williams, 2021)
  3. Scoring > 10 on the PHQ-9
  4. Have sufficient knowledge of written and spoken English to provide consent and utilize therapy resources and take assessment measures throughout the protocol without the assistance of a translator.

Exclusion Criteria:

  1. Diagnosis of a psychotic or bipolar disorder
  2. History of learning disabilities or organic brain change (e.g., from injury or from neurological disorders)
  3. Active alcohol or substance use disorder or level of use that would interfere with ability to engage in ADepT treatment
  4. Current marked risk to self (self-harm or suicidal ideation) that cannot be managed safely within the ADepT treatment frame
  5. Patients cannot be enrolled while they are currently receiving psychotherapy from a different provider in line with current clinic policy and APA ethical guidelines. The possibility of switching providers/treatments will be addressed following established departmental policies and procedures, transcranial magnetic stimulation, ketamine, esketamine, or electroconvulsive therapy. Patients receiving a stable dose of an antidepressant agent will be considered eligible.
  6. Presence of another psychiatric disorder judged to be primary

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 3 week baseline + ADepT
Baseline assessments will be made weekly for 3 weeks, followed by a standard course of ADepT.
Comportamental: Augmented Depression Therapy (ADepT)
ADepT is a solution-focused behavioral health intervention that blends techniques from cognitive, behavioral, and acceptance-based treatments to help patients manage symptoms of depression and increase wellbeing. It consists of 15 acute treatment sessions and up to 5 booster sessions.
Experimental: 4 week baseline + ADepT
Baseline assessments will be made weekly for 4 weeks, followed by a standard course of ADepT.
Comportamental: Augmented Depression Therapy (ADepT)
ADepT is a solution-focused behavioral health intervention that blends techniques from cognitive, behavioral, and acceptance-based treatments to help patients manage symptoms of depression and increase wellbeing. It consists of 15 acute treatment sessions and up to 5 booster sessions.
Experimental: 5 week baseline + ADepT
Baseline assessments will be made weekly for 5 weeks, followed by a standard course of ADepT.
Comportamental: Augmented Depression Therapy (ADepT)
ADepT is a solution-focused behavioral health intervention that blends techniques from cognitive, behavioral, and acceptance-based treatments to help patients manage symptoms of depression and increase wellbeing. It consists of 15 acute treatment sessions and up to 5 booster sessions.
Experimental: 6 week baseline + ADepT
Baseline assessments will be made weekly for 6 weeks, followed by a standard course of ADepT.
Comportamental: Augmented Depression Therapy (ADepT)
ADepT is a solution-focused behavioral health intervention that blends techniques from cognitive, behavioral, and acceptance-based treatments to help patients manage symptoms of depression and increase wellbeing. It consists of 15 acute treatment sessions and up to 5 booster sessions.
Experimental: 7 week baseline + ADepT
Baseline assessments will be made weekly for 7 weeks, followed by a standard course of ADepT.
Comportamental: Augmented Depression Therapy (ADepT)
ADepT is a solution-focused behavioral health intervention that blends techniques from cognitive, behavioral, and acceptance-based treatments to help patients manage symptoms of depression and increase wellbeing. It consists of 15 acute treatment sessions and up to 5 booster sessions.
Experimental: 8 week baseline + ADepT
Baseline assessments will be made weekly for 8 weeks, followed by a standard course of ADepT.
Comportamental: Augmented Depression Therapy (ADepT)
ADepT is a solution-focused behavioral health intervention that blends techniques from cognitive, behavioral, and acceptance-based treatments to help patients manage symptoms of depression and increase wellbeing. It consists of 15 acute treatment sessions and up to 5 booster sessions.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Acceptability
Prazo: From enrollment to the end of treatment at 82 weeks
Patient ratings of treatment acceptability
From enrollment to the end of treatment at 82 weeks
Attrition
Prazo: From enrollment to the end of treatment at 82 weeks.
Patient attendance records
From enrollment to the end of treatment at 82 weeks.
Adverse Events
Prazo: From enrollment to the end of treatment at 82 weeks.
Self-reported adverse events
From enrollment to the end of treatment at 82 weeks.

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Montgomery-Asberg Depression Rating Scale (MADRS)
Prazo: From enrollment to the end of treatment at 82 weeks.
The MADRS is a clinician-administered, 10-item assessment tool used to measure the severity of depressive symptoms and monitor changes in depression over time. Min=0, Max=60, higher scores indicate worse depression.
From enrollment to the end of treatment at 82 weeks.
Patient Health Questionnaire - 9 Item Version (PHQ-9)
Prazo: From enrollment to the end of treatment at 82 weeks.
The PHQ-9 is a 9-item self-report measure of depression severity. Min=0, Max=27, higher scores indicate worse depression.
From enrollment to the end of treatment at 82 weeks.
Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)
Prazo: From enrollment to the end of treatment at 82 weeks.
The WEMWBS is a 14-item self-report questionnaire designed to measure positive mental wellbeing, including emotional, psychological, and social functioning. Min=14, Max=70, higher scores indicate higher levels of wellbeing.
From enrollment to the end of treatment at 82 weeks.

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Ohio State University

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de agosto de 2026

Conclusão Primária (Estimado)

31 de agosto de 2028

Conclusão do estudo (Estimado)

31 de dezembro de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

23 de julho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

28 de julho de 2026

Primeira postagem (Real)

29 de julho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

29 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

28 de julho de 2026

Última verificação

1 de julho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 20251473

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

Only IRB approved personnel will have access to identifiable data. De-identified data may be shared with other research groups examining similar questions or as a requirement for publication in certain journals.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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 .

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