Developing a Telehealth + mHealth Cannabis Use Intervention for Young Adults
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Times of cannabis use
研究概览
简要总结
The goal of this clinical trial is to determine 1) feasibility of the MOMENT-V intervention for cannabis use disorder in young adults, 2) feasibility of conducting the trial remotely, and 3) whether the MOMENT-V intervention reduces cannabis use frequency and problems. Researchers will compare the MOMENT-V intervention to usual care enhanced by a counselor meeting.
Participants will either meet with a counselor two times and use an app on their phone for two weeks, or meet with a counselor briefly one time. All participants will be asked to complete electronic surveys, interviews with a research assistant, and saliva drug testing at home over three months.
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 26 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For the oral fluid testing pilot
- •Inclusion Criteria:
- •Primary care patient of the Boston Children's Hospital Adolescent/Young Adult Medicine Practice
- •Participation in MOMENT-V open pilot
- •Ownership of a smartphone
- •Availability for the 2-week study duration
排除标准
- •Inability/Unwillingness to provide contact information
- •Current pregnancy or parenting
- •For the pilot RCT
- •Inclusion Criteria:
- •Primary care patient of the Boston Children's Hospital Adolescent/Young Adult Medicine Practice or Martha Eliot Health Center Adolescent Clinic
- •18 to 26 years old
- •Cannabis Use Disorders Identification Test-Revised (CUDIT-R) score of ≥8
- •Recreational cannabis use on >3 days/week, on average, in the past 30 days
- •Ownership of a smartphone that is PIN- or password-protected
- •Ability to read and speak English
- •Availability for the 6-month study duration
- •Exclusion Criteria:
- •Inability/Unwillingness to provide contact information
- •Written certification from a physician for marijuana for medical use
- •Current participation in a substance use treatment program or research study
- •Current pregnancy or parenting
- •Participation in prior MOMENT or MOMENT-V research
研究组 & 干预措施
Enhanced Usual Care arm
Participants meet with a study counselor 1-on-1 via videoconference to review a brochure containing cannabis information and treatment resources.
干预措施: Enhanced Usual Care (Behavioral)
Intervention arm
Participants meet with a counselor 1-on-1 via videoconference and receive MOMENT-V (mHealth intervention involving 2 Motivational Enhancement Therapy [MET] sessions with a trained counselor and 2 weeks of smartphone-based Ecological Momentary Assessment [EMI]).
干预措施: Motivational Enhancement Therapy plus Ecological Momentary Intervention (Behavioral)
Oral fluid test pilot
Prior to RCT, single-arm pilot to test feasibility and acceptability of remote oral fluid testing.
结局指标
主要结局
Times of cannabis use
时间窗: At Baseline, 3-week timepoint, 3-month timepoint, 6-month timepoint
\[Aim 3\] Number of cannabis use times measured on TLFB calendar
Days of cannabis use
时间窗: At Baseline, 3-week timepoint, 3-month timepoint, 6-month timepoint
\[Aim 3\] Number of cannabis use days measured on Timeline Follow-Back (TLFB) calendar
Intervention completion
时间窗: At week 3 (Upon completion of 2-week EMI period)
\[Aim 1\] Percent of participants assigned to the intervention arm completing the intervention (defined as both MET sessions and any EMI surveys). Benchmark: ≥80%
EMI engagement
时间窗: In weeks 1-3 (during 2-week EMI period)
\[Aim 1\] Percent of days on which participant responded to at least one survey during the 14 days of EMI. Benchmark: Median of ≥80% across intervention participants
Acceptability: Overall satisfaction
时间窗: At 6-month timepoint
\[Aim 1\] Satisfaction with intervention measured on the Client Satisfaction Questionnaire-8, an 8-item 4-point scale on which scores range from 8-32, with higher scores indicating greater satisfaction. Benchmark: ≥80% of participants with a scale score ≥24 (mean item score of ≥3 out 4)
Acceptability: Components
时间窗: At week 0, week 1, and week 3
\[Aim 1\] Measure of acceptability (usability, likability, perceived effect, burden) for each intervention component (2 MET sessions and EMI). Components assessed with an 11- or 12-item 5-point Likert-type scales (1, Strongly Disagree to 5, Strongly Agree) developed for the study. Higher scores indicate greater acceptability. Benchmark for each scale: ≥80% of participants with mean item score ≥4 out of 5
Screening
时间窗: During recruitment (upon completion of eligibility survey: pre-enrollment, pre-Baseline)
\[Aim 2\] Number of patients self-screening per month. Benchmark: ≥13 per month
Eligibility
时间窗: During recruitment (upon completion of eligibility survey: pre-enrollment, pre-Baseline)
\[Aim 2\] Number of patients eligible per month. Benchmark: ≥6 per month
Enrollment
时间窗: Upon enrollment
\[Aim 2\] Number of patients enrolled per month. Benchmark: ≥3 per month
Retention in trial
时间窗: At 3-week timepoint, 3-month timepoint, 6-month timepoint
\[Aim 2\] Percent of participants retained at each assessment time point (3 weeks, 3 months, 6 months, by assigned condition. Benchmark: ≥80% at each time point
Negative consequences of cannabis use
时间窗: At Baseline, 3-month timepoint, 6-month timepoint
\[Aim 3\] Number of negative consequences (problems) measured on the 19-item Marijuana Problems Scale
次要结局
- Therapeutic alliance(At week 1)
- MET counselor adherence to MI principles(At week 0 and week 1)
- Duration of study activities(All timepoints, upon completion of each timepoint (Baseline, week 0, week 1, weeks 1-3 [two-week EMI period], 3-weeks, 3-months, 6-months))
- Cannabis use disorder (CUD) symptoms(At Baseline, 3-month timepoint, 6-month timepoint)
- Amount of THC used(At Baseline, 3-week timepoint, 3-month timepoint, 6-month timepoint)
- Motivation to change cannabis use(At Baseline, week 0, week 1, 3-months, 6-months)
- Psychological distress(At Baseline, 3-month timepoint, 6-month timepoint)
- Cognitive function(At Baseline, 3-month timepoint, 6-month timepoint)
- Quality of life(At Baseline, 3-month timepoint, 6-month timepoint)
研究者
Lydia Shrier
Research Director, Division of Adolescent/Young Adult Medicine
Boston Children's Hospital