Augmented Depression Therapy (ADepT) Case Series

Обзор

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.

Вмешательства

• Поведенческое 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.

Первичные конечные точки

• Acceptability [Срок оценки: From enrollment to the end of treatment at 82 weeks]
• Attrition [Срок оценки: From enrollment to the end of treatment at 82 weeks.]
• Adverse Events [Срок оценки: From enrollment to the end of treatment at 82 weeks.]

Вторичные конечные точки (3)

• Montgomery-Asberg Depression Rating Scale (MADRS) [Срок оценки: From enrollment to the end of treatment at 82 weeks.]
• Patient Health Questionnaire - 9 Item Version (PHQ-9) [Срок оценки: From enrollment to the end of treatment at 82 weeks.]
• Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) [Срок оценки: From enrollment to the end of treatment at 82 weeks.]

Критерии участия

Критерии включения

• Aged 18 -65
• Currently experiencing a major depressive episode based on the Quick Structured Clinical Interview for DSM-5 Disorders (QuickSCID-5; First \& Williams, 2021)
• Scoring > 10 on the PHQ-9
• 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.

Критерии исключения

• Diagnosis of a psychotic or bipolar disorder
• History of learning disabilities or organic brain change (e.g., from injury or from neurological disorders)
• Active alcohol or substance use disorder or level of use that would interfere with ability to engage in ADepT treatment
• Current marked risk to self (self-harm or suicidal ideation) that cannot be managed safely within the ADepT treatment frame
• 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.
• Presence of another psychiatric disorder judged to be primary

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• The Ohio State University Wexner Medical Center — Columbus

Идентификаторы

NCT: NCT07733310 · 20251473

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗