AMP-C: A Digital Therapeutic for Reward Dysfunction in Co-Occurring Depression and Cannabis Use
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Usability (System Usability Scale; SUS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Symptom Tracking
Amplification of Positivity - Cannabis Use (AMP-C)
干预措施: Amplification of Positivity - Cannabis Use (AMP-C) (Behavioral)
结局指标
主要结局
Usability (System Usability Scale; SUS)
时间窗: 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.
Change in Depressive Symptoms (Patient Health Questionnaire-9; PHQ-9)
时间窗: 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)
时间窗: 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.
次要结局
- 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 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)
- Changes in passively assessed behavioral activation(Continuously 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)
- 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)
研究者
Amanda C. Collins
Principal Investigator
Massachusetts General Hospital