Cannabis Use Disorder, Depression - Major Depressive Disorder, Mental Disorder
Conditions
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.
Interventions
BEHAVIORALAmplification of Positivity - Cannabis Use (AMP-C)
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.
Sponsors
Massachusetts General Hospital
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Depressive Symptoms (Patient Health Questionnaire-9; PHQ-9) | 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 | 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 Frequency (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: Intervention Midpoint (4 weeks into intervention), 1-, 3-, 6-, and 12-months after completing intervention | 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. |
| 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. An average score of 68 or greater on the SUS in our AMP-C group will indicate acceptable usability. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility (Engagement) | Post-Intervention (approximately one week after completing intervention) | Feasibility will be measured through the number of modules completed for the AMP-C group. |
| Intervention Feasibility (App Usage) | Post-Intervention (approximately one week after completing intervention) | Feasibility will be measured through app usage time (hours). |
| Change 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. |
| 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 | The Positive and Negative Affect Schedule Scale-Positive Affect (PANAS-PA) is a 10-item self-report measure that assesses positive affect over the past week. Total scores range from 10-50, with greater scores representing greater positive affect. |
| 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 Negative Affect (Positive and Negative Affect Schedule-Negative Affect; PANAS-NA) | 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 Scale-Negative Affect (PANAS-NA) is a 10-item self-report measure that assesses negative affect over the past week. Total scores range from 10-50, with greater scores representing greater negative affect. |
| Changes in passively assessed behavioral activation | Continuously for 8 weeks during intervention | Passive sensing behaviors will be continuously collected without requiring participant input and will be related to behavioral activation (measured through GPS mobility). Changes in behaviors (e.g., increased GPS mobillity) will indicate greater behavioral activation during the course of the intervention for the AMP-C group. |
Countries
United States
Outcome results
None listed