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

NCT06878859 | Recruiting

• 2 other identifiers: 2025p0005831K23DA062034
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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 changes in depressive symptoms and cannabis use, as well as usability ratings.

Conditions

Depression - Major Depressive Disorder; Cannabis Use Disorder; Mental Disorder

Outcome Measures

Primary Outcomes (3)

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

  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.

  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)

  Cannabis use 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. Our primary outcome will assess changes in frequency.

  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)

  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. An average score of 68 or greater on the SUS in our AMP-C group will indicate acceptable usability.

  Post-Intervention (approximately one week after completing intervention)

Secondary Outcomes (8)

• Feasibility (Engagement)

  Post-Intervention (approximately one week after completing intervention)

• Intervention Feasibility (App Usage)

  Post-Intervention (approximately one week after completing intervention)

• Change in Daily Depressive Symptoms (Mobile Patient Health Questionnaire-9; MPHQ-9)

  Daily for 8 weeks during intervention

• Changes in Daily Cannabis Use

  Daily for 8 weeks during intervention

• Change in Positive Affect (Positive and Negative Affect Schedule-Positive Affect; PANAS-PA)

  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

Other Outcomes (9)

• 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

• 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

• 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

Study Arms (2)

Amplification of Positivity - Cannabis Use (AMP-C)

EXPERIMENTAL

Behavioral: Amplification of Positivity - Cannabis Use (AMP-C)

Symptom Tracking

NO INTERVENTION

Interventions

Amplification of Positivity - Cannabis Use (AMP-C) BEHAVIORAL

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.

Amplification of Positivity - Cannabis Use (AMP-C)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 6, 2025
• First Posted: March 17, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)