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Идёт набор NCT06878859

Preliminary Efficacy Trial of a Digital Intervention for Depression and Cannabis Use

Без фазы С лечением Depression - Major Depressive Disorder Cannabis Use Disorder Mental Disorder

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Amplification of Positivity - Cannabis Use (AMP-C).
Кому может быть актуально
Состояния в реестре: Depression - Major Depressive Disorder, Cannabis Use Disorder, Mental Disorder. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

AMP-C: A Digital Therapeutic for Reward Dysfunction in Co-Occurring Depression and Cannabis Use

Обзор

The purpose of this study is to examine the feasibility, acceptability, and preliminary efficacy of a digital intervention for co-occurring cannabis use and depression. Participants will be randomized to complete Amplification of Positivity - Cannabis Use (AMP-C) or symptom tracking. The main outcomes will include changes in depressive symptoms and cannabis use, as well as usability ratings.

Вмешательства

  • Поведенческое Amplification of Positivity - Cannabis Use (AMP-C)
    AMP-C is a smartphone-based digital intervention that includes activities that focus on positivity (e.g., noticing and capitalizing on positive events) to increase positive emotions, thoughts, and behaviors. The role and impact of CU on the maintenance of depression and reward dysfunction (and vice versa), is intertwined throughout the intervention.

Первичные конечные точки

  • Change in Depressive Symptoms (Patient Health Questionnaire-9; PHQ-9) [Срок оценки: Baseline, Primary Endpoint: Post-Intervention (approximately one week after completing intervention), Secondary Endpoints: Intervention Midpoint (4 weeks into intervention), 1-, 3-, 6-, and 12-months after completing intervention]
  • Change in Cannabis Use Frequency (Daily Sessions, Frequency, Age of Onset, and Quantity of Cannabis Use Inventory; DFAQ-CU) [Срок оценки: Baseline, Primary Endpoint: Post-Intervention (approximately one week after completing intervention), Secondary Endpoints: Intervention Midpoint (4 weeks into intervention), 1-, 3-, 6-, and 12-months after completing intervention]
  • Usability (System Usability Scale; SUS) [Срок оценки: Post-Intervention (approximately one week after completing intervention)]
Вторичные конечные точки (8)
  • Feasibility (Engagement) [Срок оценки: Post-Intervention (approximately one week after completing intervention)]
  • Intervention Feasibility (App Usage) [Срок оценки: Post-Intervention (approximately one week after completing intervention)]
  • Change in Daily Depressive Symptoms (Mobile Patient Health Questionnaire-9; MPHQ-9) [Срок оценки: Daily for 8 weeks during intervention]
  • Changes in Daily Cannabis Use [Срок оценки: Daily for 8 weeks during intervention]
  • Change in Positive Affect (Positive and Negative Affect Schedule-Positive Affect; PANAS-PA) [Срок оценки: Baseline, Primary Endpoint: Post-Intervention (approximately one week after completing intervention), Secondary Endpoints: Intervention Midpoint (4 weeks into intervention), 1-, 3-, 6-, and 12-months after completing intervention]
  • Change in Anticipatory and Consummatory Anhedonia (Temporal Experience of Pleasure Scale; TEPS) [Срок оценки: Baseline, Primary Endpoint: Post-Intervention (approximately one week after completing intervention), Secondary Endpoints: 1-, 3-, 6-, and 12-months after completing intervention]
  • Change in Negative Affect (Positive and Negative Affect Schedule-Negative Affect; PANAS-NA) [Срок оценки: Baseline, Primary Endpoint: Post-Intervention (approximately one week after completing intervention), Secondary Endpoints: 1-, 3-, 6-, and 12-months after completing intervention]
  • Changes in passively assessed behavioral activation [Срок оценки: Continuously for 8 weeks during intervention]

Критерии участия

Критерии включения

  • Aged ≥ 18 years
  • Resides in the United States
  • Able to read and understand English and willing to provide informed consent/comply with the study protocol
  • Moderate depressive symptom severity, as indicated by the Patient Health Questionnaire-9 (PHQ-9)
  • Problematic cannabis use, as indicated by the Cannabis Use Disorder Identification Test - Revised (CUDIT-R)
  • Current elevated anhedonia, as indicated by the PHQ-9
  • Interest in receiving treatment for their cannabis use and depression
  • Meet criteria for current MDD and CUD per the DSM-5

Критерии исключения

  • History of a psychotic disorder or bipolar disorder type I/II
  • Active suicidal ideation or intent based on the Columbia-Suicide Severity Rating Scale
  • Current psychotherapy engagement
  • Changes in psychotropic medication within six weeks of the start of study

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Massachusetts General Hospital — Boston

Идентификаторы

NCT: NCT06878859 · 2025p000583 · 1K23DA062034

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗