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

Not Applicable

Not yet recruiting

• Conditions: Depression - Major Depressive Disorder; Cannabis Use Disorder; Mental Disorder

• Registration Number: NCT06878859
• Lead Sponsor: Massachusetts General Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-06
• Study First Submitted QC: 2025-03-10
• Last Update Submitted: 2025-03-10
• Study First Posted: 2025-03-17
• Last Update Posted: 2025-03-17
• Study Start: 2025-10
• Primary Completion: 2027-12
• Study Completion: 2030-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Usability (System Usability Scale; SUS)	Post-Intervention (approximately one week after completing intervention)	The System Usability Scale (SUS) is a 10-item self-report measure commonly used to assess the degree to which participants endorse ease of use following task-based operation of computer systems (i.e., perceived usability). Total scores on the SUS range from 0 to 100, with greater scores indicating greater usability.
Intervention Feasibility (App Usage)	Post-Intervention (approximately one week after completing intervention)	Feasibility will be measured through app usage time (hours).
Change in Depressive Symptoms (Patient Health Questionnaire-9; PHQ-9)	Baseline, Primary Endpoint: Post-Intervention (approximately one week after completing intervention), Secondary Endpoints: 1-, 3-, 6-, and 12-months after completing intervention	Depressive symptoms will be measured with the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is a widely-used 9-item self-report measure that assesses depressive symptom severity over the previous two weeks. Scores on the PHQ-9 range from 0-27, with greater scores indicating greater depression severity.
Change in Cannabis Use (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: 1-, 3-, 6-, and 12-months after completing intervention	Cannabis use will be measured with the Daily Sessions, Frequency, Age of Onset, and Quantity of Cannabis Use Inventory (DFAQ-CU). The DFAQ-CU is a 24-item self-report measure that assesses frequency, age of onset, and quantity of cannabis use. There are six factors: daily sessions, frequency, age of onset, marijuana quantity, concentrate quantity, and edible quantity. The six factors, except age of onset, are independently scored, and higher scores indicate greater cannabis use.
Acceptability (Treatment Adherence and Acceptability Scale; TAAS)	Pre-Intervention (Baseline)	The Treatment Adherence and Acceptability Scale (TAAS) is a 10-item self-report measure developed to assess (a) the degree to which a client finds a treatment to be acceptable, and (b) self-reported likelihood a client anticipates they will adhere to proposed treatment procedures. A total score, ranging from 7-70, is calculated by summing all items with greater scores indicating greater acceptability.
Changes in Daily Depressive Symptoms (Mobile Patient Health Questionnaire-9; MPHQ-9)	Daily for 8 weeks during intervention	Daily depressive symptoms will be measured with the Mobile Patient Health Questionnaire-9 (MPHQ-9). The MPHQ-9 is a modified version of the paper PHQ-9, which has been used in intensive sampling studies. Participants answer questions regarding their experience with the nine symptoms of MDD over the past 24 hours on a sliding scale. Total scores range from 0-900, with greater scores representing greater depression severity.
Changes in Daily Cannabis Use	Daily for 8 weeks during intervention	Daily cannabis use will be measured with a series of questions related to cannabis use consumption. These questions will capture frequency, quantity, product types, potencies, and administration methods of cannabis over the past 24 hours.
Feasibility (Engagement)	Post-Intervention (approximately one week after completing intervention)	Feasibility will be measured through the number of modules completed.

Secondary Outcome Measures

Name	Time	Method
Change in Positive Affect (Positive and Negative Affect Schedule; PANAS-PA)	Baseline, Primary Endpoint: Post-Intervention (approximately one week after completing intervention), Secondary Endpoints: 1-, 3-, 6-, and 12-months after completing intervention	The Positive and Negative Affect Schedule (PANAS) is a 20-item self-report measure that assesses affect for the current day. The PANAS has two subscales (10 items each) that represent overall positive affect (PA) and overall negative affect (NA). Total scores range from 20-100 (or 10-50 for each subscale), with greater scores representing greater affect.
Change in Substance Use (Timeline Followback; TLFB)	Baseline, Primary Endpoint: Post-Intervention (approximately one week after completing intervention), Secondary Endpoints: 1-, 3-, 6-, and 12-months after completing intervention	Broader substance use will be measured with the Timeline Followback (TLFB). The TLFB is a self-report measure that assesses substance use and related behaviors over the past 30 days. Participants will be asked to identify the number of days over the 30 days in which they have consumed alcohol, tobacco/nicotine, opioids, stimulants, hallucinogens, sedatives/depressives, inhalants, and other illicit or prescription drugs. Total scores are not calculated, but the outcomes of interest include number of days per substance, with greater scores indicating a higher number of days of substance use in the past 30 days.
Change in Anticipatory and Consummatory Anhedonia (Temporal Experience of Pleasure Scale; TEPS)	Baseline, Primary Endpoint: Post-Intervention (approximately one week after completing intervention), Secondary Endpoints: 1-, 3-, 6-, and 12-months after completing intervention	Anticipatory and consummatory anhedonia will be measured with the Temporal Experience of Pleasure Scale (TEPS). The TEPS is a 18-item self-report measure that assesses reward anticipation (e.g., motivation) and responsiveness (e.g., pleasure). There are two subscales in the TEPS: anticipatory anhedonia and consummatory anhedonia. Scores on the anticipatory subscale range from 10 to 60, and scores on the consummatory subscale range from 8 to 48. Higher scores indicate greater pleasure.
Change in Anhedonia (Specific Loss of Interest and Pleasure Scale; SLIPS)	Post-Intervention (approximately one week after completing intervention)	Recent changes in anhedonia will be measured with the Specific Loss of Interest and Pleasure Scale (SLIPS). The SLIPS is a 23-item self-report measure that assesses for changes in anhedonia over the previous two weeks. Total scores on the SLIPS range from 0-46, with greater scores indicating greater changes in anhedonia over the previous two weeks.
Change in Anxiety Symptoms (Generalized Anxiety Disorder-7; GAD-7)	Baseline, Primary Endpoint: Post-Intervention (approximately one week after completing intervention), Secondary Endpoints: 1-, 3-, 6-, and 12-months after completing intervention	Anxiety symptoms will be measured with the Generalized Anxiety Disorder-7 (GAD-7). The GAD-7 is a 7-item self-report measure that assesses anxiety symptom severity over the previous two weeks. Total scores range from 0-21, with higher scores representing higher anxiety severity.
Change in Alcohol Use (Drinking Motives Questionnaire-Revised; DMQR)	Baseline, Primary Endpoint: Post-Intervention (approximately one week after completing intervention), Secondary Endpoints: 1-, 3-, 6-, and 12-months after completing intervention	Reasons for drinking alcohol will be measured with the Drinking Motives Questionnaire-Revised (DMQR). The DMQR is a 20-item self-report measure that assesses common reasons for why people might drink alcohol. There are four subscales: Social, Coping, Enhancement, and Conformity. Subscale scores range from 1-25, with greater scores representing greater endorsement of specific reasons for drinking alcohol.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States