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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Amplification of Positivity - Cannabis Use (AMP-C)Experimental treatment 1 intervention
Group B: Symptom TrackingNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
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
2

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.

Time frame
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
3

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.

Time frame
Post-Intervention (approximately one week after completing intervention)

Secondary outcomes

1

Feasibility (Engagement)

Feasibility will be measured through the number of modules completed for the AMP-C group.

Time frame
Post-Intervention (approximately one week after completing intervention)
2

Intervention Feasibility (App Usage)

Feasibility will be measured through app usage time (hours).

Time frame
Post-Intervention (approximately one week after completing intervention)
3

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

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.

Time frame
Daily for 8 weeks during intervention
4

Changes in Daily Cannabis Use

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.

Time frame
Daily for 8 weeks during intervention

Other outcomes

1

Change in Alcohol Use (Drinking Motives Questionnaire-Revised; DMQR)

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.

Time frame
Baseline, Primary Endpoint: Post-Intervention (approximately one week after completing intervention), Secondary Endpoints: 1-, 3-, 6-, and 12-months after completing intervention
2

Change in Substance Use (Timeline Followback; TLFB)

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.

Time frame
Baseline, Primary Endpoint: Post-Intervention (approximately one week after completing intervention), Secondary Endpoints: 1-, 3-, 6-, and 12-months after completing intervention
3

Change in Anxiety Symptoms (Generalized Anxiety Disorder-7; GAD-7)

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.

Time frame
Baseline, Primary Endpoint: Post-Intervention (approximately one week after completing intervention), Secondary Endpoints: 1-, 3-, 6-, and 12-months after completing intervention
4

Change in Fear of Happiness (Fear of Happiness Scale; FHS)

The Fear of Happiness Scale (FHS) is a 9-item self-report measure that assesses fear and apprehension of positivity due to its association with negative outcomes. Total scores range from 0-36, with greater scores representing greater fear of happiness.

Time frame
Baseline, Primary Endpoint: Post-Intervention (approximately one week after completing intervention), Secondary Endpoints: 1-, 3-, 6-, and 12-months after completing intervention

Sponsors and contacts

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Massachusetts General Hospital

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator