Clinical trial NCT06878859: Preliminary Efficacy Trial of a Digital Intervention for Depression and Cannabis Use
Official title: AMP-C: A Digital Therapeutic for Reward Dysfunction in Co-Occurring Depression and Cannabis Use
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Depression - Major Depressive Disorder
Cannabis Use Disorder
Mental Disorder
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2025-03-17
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 participant acceptability and usability ratings, completion rates and compliance, positive affect, substance use, and depression severity.


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/or 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

Primary outcomes:
measure: Usability (System Usability Scale; SUS)
timeFrame: Post-Intervention (approximately one week after completing intervention)
measure: Intervention Feasibility (App Usage)
timeFrame: Post-Intervention (approximately one week after completing intervention)
measure: Change in Depressive Symptoms (Patient Health Questionnaire-9; PHQ-9)
timeFrame: Baseline, Primary Endpoint: Post-Intervention (approximately one week after completing intervention), Secondary Endpoints: 1-, 3-, 6-, and 12-months after completing intervention
measure: Change in Cannabis Use (Daily Sessions, Frequency, Age of Onset, and Quantity of Cannabis Use Inventory; DFAQ-CU)
timeFrame: Baseline, Primary Endpoint: Post-Intervention (approximately one week after completing intervention), Secondary Endpoints: 1-, 3-, 6-, and 12-months after completing intervention
measure: Acceptability (Treatment Adherence and Acceptability Scale; TAAS)
timeFrame: Pre-Intervention (Baseline)
measure: Changes in Daily Depressive Symptoms (Mobile Patient Health Questionnaire-9; MPHQ-9)
timeFrame: Daily for 8 weeks during intervention
measure: Changes in Daily Cannabis Use
timeFrame: Daily for 8 weeks during intervention
measure: Feasibility (Engagement)
timeFrame: Post-Intervention (approximately one week after completing intervention)
Secondary outcomes:
measure: Change in Positive Affect (Positive and Negative Affect Schedule; PANAS-PA)
timeFrame: Baseline, Primary Endpoint: Post-Intervention (approximately one week after completing intervention), Secondary Endpoints: 1-, 3-, 6-, and 12-months after completing intervention
measure: Change in Alcohol Use (Drinking Motives Questionnaire-Revised; DMQR)
timeFrame: Baseline, Primary Endpoint: Post-Intervention (approximately one week after completing intervention), Secondary Endpoints: 1-, 3-, 6-, and 12-months after completing intervention
measure: Change in Substance Use (Timeline Followback; TLFB)
timeFrame: Baseline, Primary Endpoint: Post-Intervention (approximately one week after completing intervention), Secondary Endpoints: 1-, 3-, 6-, and 12-months after completing intervention
measure: Change in Anticipatory and Consummatory Anhedonia (Temporal Experience of Pleasure Scale; TEPS)
timeFrame: Baseline, Primary Endpoint: Post-Intervention (approximately one week after completing intervention), Secondary Endpoints: 1-, 3-, 6-, and 12-months after completing intervention
measure: Change in Anhedonia (Specific Loss of Interest and Pleasure Scale; SLIPS)
timeFrame: Post-Intervention (approximately one week after completing intervention)
measure: Change in Anxiety Symptoms (Generalized Anxiety Disorder-7; GAD-7)
timeFrame: Baseline, Primary Endpoint: Post-Intervention (approximately one week after completing intervention), Secondary Endpoints: 1-, 3-, 6-, and 12-months after completing intervention
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References: