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Preliminary Efficacy Trial of a Digital Intervention for Depression and Cannabis Use
NCT06878859 · Massachusetts General Hospital
In plain English
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Official title
AMP-C: A Digital Therapeutic for Reward Dysfunction in Co-Occurring Depression and Cannabis Use
About this study
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.
Eligibility criteria
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Study design
Enrollment target: 80 participants
Allocation: randomized
Masking: single
Age groups: adult, older_adult
Timeline
Starts: 2026-02
Estimated completion: 2029-01
Last updated: 2026-02-27
Interventions
Behavioral: Amplification of Positivity - Cannabis Use (AMP-C)
Primary outcomes
- • Change in Depressive Symptoms (Patient Health Questionnaire-9; PHQ-9) (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) (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) (Post-Intervention (approximately one week after completing intervention))
Sponsor
Massachusetts General Hospital · other
With: National Institute on Drug Abuse (NIDA)
All locations (1)
Massachusetts General HospitalRecruiting
Boston, Massachusetts, United States