Digital Intervention for Depression and Cannabis Use

Overseen By Amanda C Collins, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Must not be taking: Psychotropic medications

Disqualifiers: Psychotic disorder, Bipolar, Suicidal, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a digital program called Amplification of Positivity - Cannabis Use (AMP-C) to determine its effectiveness for individuals struggling with both depression and cannabis use. Participants will either engage with the AMP-C program, which focuses on enhancing positive emotions, or track their symptoms. The study examines the program's reception, ease of use, and impact on mood and cannabis habits. It suits individuals in the U.S. with ongoing depression and problematic cannabis use who seek help for these issues. As an unphased trial, this study provides a unique opportunity to explore a new approach to managing depression and cannabis use.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must not have changed any psychotropic medications (medications affecting mood, perception, or behavior) within six weeks before starting the study.

What prior data suggests that this digital intervention is safe for treating depression and cannabis use?

Research has shown that the Amplification of Positivity - Cannabis Use (AMP-C) treatment is safe. Previous studies have examined its usability and participant acceptance. Most participants found the treatment acceptable and easy to use. No reports of serious side effects have emerged, indicating it is well-tolerated.

The AMP-C treatment is a digital program designed to address both depression and cannabis use by enhancing positive feelings. As it is not a medication, the risk of side effects is lower compared to drug treatments.

Although this trial has not yet gathered its own data, the nature of the treatment and past feedback suggest it is safe. Participants can feel confident about the safety of this digital program. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Amplification of Positivity - Cannabis Use (AMP-C) treatment because it offers a fresh approach to tackling both depression and cannabis use simultaneously. Unlike traditional therapies that might involve medications or counseling, AMP-C leverages digital interventions to focus on enhancing positive emotions and experiences. This unique method is designed to not only reduce negative symptoms but also actively promote positive ones, potentially leading to a more holistic and effective treatment outcome. By shifting the focus from merely symptom tracking to actively boosting positivity, AMP-C could provide a more engaging and motivating treatment experience for patients.

What evidence suggests that this digital intervention is effective for depression and cannabis use?

Research shows that the Amplification of Positivity - Cannabis Use (AMP-C) treatment, which participants in this trial may receive, can alleviate anxiety and depression and enhance social connections. This digital program targets the improvement of reward experiences, often challenging for those facing both cannabis use and depression. Studies have found that AMP-C boosts positive feelings and promotes social interaction, both crucial for mental health. Although still in early stages, the treatment appears promising for reducing symptoms of depression and cannabis use. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals with Major Depressive Disorder and Cannabis Use Disorder. Participants should be experiencing depression alongside cannabis abuse issues but not have other psychiatric conditions that could interfere with the study.

Inclusion Criteria

Resides in the United States

Current elevated anhedonia, as indicated by the PHQ-9

Able to read and understand English and willing to provide informed consent/comply with the study protocol

Exclusion Criteria

Active suicidal ideation or intent based on the Columbia-Suicide Severity Rating Scale

History of a psychotic disorder or bipolar disorder type I/II

I am currently seeing a therapist or counselor.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants are randomized to complete either the AMP-C digital intervention or symptom tracking for 8 weeks

8 weeks

Daily self-reporting via digital platform

Post-Intervention Assessment

Participants' usability, cannabis use, depressive symptoms, and other outcomes are assessed approximately one week after completing the intervention

1 week

Follow-up

Participants are monitored for changes in cannabis use, depressive symptoms, and other outcomes at 1-, 3-, 6-, and 12-months after completing the intervention

12 months

What Are the Treatments Tested in This Trial?

Interventions

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

Trial Overview The study tests a digital program called Amplification of Positivity - Cannabis Use (AMP-C) against simple symptom tracking to see which helps more with mood and reducing cannabis use. People will be randomly assigned to one of these two approaches.

How Is the Trial Designed?

Group I: Amplification of Positivity - Cannabis Use (AMP-C) Experimental Treatment 1 Intervention

Group II: Symptom Tracking Active Control 1 Intervention

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

The digital intervention ICan, which incorporates motivational interviewing and cognitive behavioral therapy, was more effective than standard educational information in reducing the amount of cannabis used over a 3-month period, showing a significant reduction in grams used (P=0.009).

However, by the 6-month follow-up, both the ICan and control groups showed similar reductions in the number of cannabis use days, indicating that while ICan had initial benefits, its long-term effectiveness in reducing frequency of use was not significantly different from the control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A guided digital intervention to reduce cannabis use: The ICan randomized controlled trial. Olthof, MIA., Goudriaan, AE., van Laar, MW., et al.[2023]

In a study of 97 participants with comorbid depression and substance misuse, intensive motivational interviewing and cognitive behavior therapy (MI/CBT) significantly improved depression symptoms compared to a brief intervention alone, with both live and computer-based formats showing effectiveness at the 12-month follow-up.

Computer-based therapy for depression and substance use was found to be at least as effective as live therapy, particularly in reducing cannabis use and hazardous substance use, suggesting that integrated computer-based interventions could be a viable option in primary care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer-based psychological treatment for comorbid depression and problematic alcohol and/or cannabis use: a randomized controlled trial of clinical efficacy. Kay-Lambkin, FJ., Baker, AL., Lewin, TJ., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12063735/

Amplification of Positivity Treatment for Anxiety and Depression AMP yielded larger improvements on positive affect and approach behavior during the affiliation task (but not other outcomes), and social connectedness. Larger ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06878859?term=cannabis

Preliminary Efficacy Trial of a Digital Intervention for ... The main outcomes will include participant acceptability and usability ratings, completion rates and compliance, positive affect, substance use, ...

3. c4tbh.org c4tbh.org/research-study/amp-c-a-digital-therapeutic-for-reward-dysfunction-in-co-occurring-depression-and-cannabis-use/

AMP-C: A Digital Therapeutic for Reward Dysfunction in Co ... Dr. Collins has developed AMP-C, a DTx that targets the reward dysfunction in co-occurring CUD and MDD.

4. sciencedirect.com sciencedirect.com/science/article/pii/S0006322323014981

Amplification of Positivity Treatment for Anxiety and ... AMP yielded larger improvements in positive affect and approach behavior during the affiliation task (but not other outcomes) and social ...

5. withpower.com withpower.com/trial/phase-depressive-disorder-major-9-2025-871a2

Digital Intervention for Depression and Cannabis Use What data supports the effectiveness of the treatment Amplification of Positivity - Cannabis Use (AMP-C) for depression and cannabis use? Research shows ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11514326/

Mixed Methods Investigation - PMC - PubMed Central - NIH The purpose of this study is to describe the process of eliciting feedback from individuals with elevated depressed symptoms and cannabis use and co-designing ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8752639/

Amplification of Positivity Therapy for Co-occurring Alcohol ... The current study examined the feasibility and potential benefit of a behavioral intervention focused on amplification of positivity (AMP) with eight adults.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06030154

NCT06030154 | Amplification of Positivity for Alcohol Use The current study would test the feasibility and acceptability of a 12-session protocol focused on amplification of positivity with populations experiencing ...