RecruitingNot Applicable

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

United States80 participantsStarted 2026-02-23

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is testing a digital intervention — meaning an app or online tool — for both depression and cannabis use at the same time; would that kind of self-guided digital approach be realistic for where I am right now with my symptoms, or do I need more direct clinical support?
2Since this trial is listed as Phase NA, which often means it's an early feasibility or pilot study, what does that mean for how much we already know about whether this approach is safe and actually works for someone with my level of depression?
3The trial is measuring both how often I use cannabis and how depressed I feel using standardized questionnaires — given my specific situation, do you think those are the right outcomes to focus on, or is there something else about my health that wouldn't be captured here?
4Because this is studying depression and cannabis use together, could you help me understand whether my cannabis use is considered significant enough that it needs to be addressed alongside my depression, or whether treating my depression first through standard care might be a better path?
5What would I be giving up, or potentially delaying, if I joined this study instead of starting a proven treatment for my depression right now?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Depressive Symptoms (Patient Health Questionnaire-9; PHQ-9)

Timeframe: 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)

Usability (System Usability Scale; SUS)

Timeframe: Post-Intervention (approximately one week after completing intervention)

Trial details

NCT IDNCT06878859

SponsorMassachusetts General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-01-31

View on ClinicalTrials.gov More Depression - Major Depressive Disorder trials