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

80 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Amplification of Positivity - Cannabis Use (AMP-C) for depression and cannabis use?

Research shows that a similar computer-assisted treatment combining cognitive behavioral therapy (CBT) and motivational enhancement therapy (MET) was found to be helpful and acceptable for people with both depression and cannabis use issues. Participants in this study reduced their cannabis use and found the treatment supportive in reaching their goals. ^{1 2 3 4 5}

Is the digital intervention for depression and cannabis use safe for humans?

The SHADE intervention, which combines cognitive behavioral therapy and motivational enhancement therapy, was found to be acceptable and helpful by participants, with a high completion rate, suggesting it is generally safe. However, medical cannabis use has been associated with an increased risk of depressive disorders, indicating the need for careful consideration of risks and benefits. ^{1 6 7 8 9}

What makes the AMP-C treatment unique for depression and cannabis use?

The AMP-C treatment is unique because it combines digital interventions specifically targeting both depression and cannabis use, using techniques like cognitive behavioral therapy (CBT) and motivational enhancement therapy (MET) to help individuals manage these conditions together, which is not commonly addressed in standard treatments. ^{1 3 10 11 12}

What is the purpose of this trial?

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Preliminary Outcomes of a Computerized CBT/MET Intervention for Depressed Cannabis Users in Psychiatry Care. [2020]

2. England 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. [2022]

3. England pubmed.ncbi.nlm.nih.gov

A guided digital intervention to reduce cannabis use: The ICan randomized controlled trial. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Depressive symptoms moderate cannabis use for young adults in a Text-Delivered randomized clinical trial for cannabis use disorder. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Young adults' perceptions of acceptability and effectiveness of a text message-delivered treatment for cannabis use disorder. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Cannabis and Depression. [2021]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Patient-Reported Symptom Relief Following Medical Cannabis Consumption. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Assessment of clinical outcomes of medicinal cannabis therapy for depression: analysis from the UK Medical Cannabis Registry. [2023]

9. Ireland pubmed.ncbi.nlm.nih.gov

Risk of depressive disorders associated with medical cannabis authorization: A propensity score matched cohort study. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Towards a comprehensive developmental model of cannabis use disorders. [2021]

11. Ireland pubmed.ncbi.nlm.nih.gov

Short- and long-term effects of digital prevention and treatment interventions for cannabis use reduction: A systematic review and meta-analysis. [2020]

12. United States pubmed.ncbi.nlm.nih.gov

Major depressive disorder, suicidal ideation, and suicide attempt in twins discordant for cannabis dependence and early-onset cannabis use. [2022]