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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
65
Two Motivational Enhancement Therapy (MET) sessions (1st, \~45 minutes; 2nd, \~30 minutes) between counselor and participant occur one week apart. MET sessions are personalized, interactive, face-to-face, and delivered according to a manual. MET session discussion topics include triggers for cannabis use, life goals/values, and development of a change plan. Participants then complete a 2-week Ecological Momentary Intervention (EMI) period. Survey prompts are sent 4x/day (3x/day at quasi-randomized times, 1x/day at fixed time; \~2 mins each) that ask about the participant's recent cannabis use. Depending on answers reported, the participant can receive tailored messages that support their self-efficacy and prompt use of coping strategies.
Participants meet with a study counselor 1-on-1 via videoconference to review a brochure containing cannabis information and treatment resources.
Boston Children's Hospital
Boston, Massachusetts, United States
Intervention completion
\[Aim 1\] Percent of participants assigned to the intervention arm completing the intervention (defined as both MET sessions and any EMI surveys). Benchmark: ≥80%
Time frame: At week 3 (Upon completion of 2-week EMI period)
EMI engagement
\[Aim 1\] 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
Time frame: In weeks 1-3 (during 2-week EMI period)
Acceptability: Overall satisfaction
\[Aim 1\] 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)
Time frame: At 6-month timepoint
Acceptability: Components
\[Aim 1\] 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
Time frame: At week 0, week 1, and week 3
Screening
\[Aim 2\] Number of patients self-screening per month. Benchmark: ≥13 per month
Time frame: During recruitment (upon completion of eligibility survey: pre-enrollment, pre-Baseline)
Eligibility
\[Aim 2\] Number of patients eligible per month. Benchmark: ≥6 per month
Time frame: During recruitment (upon completion of eligibility survey: pre-enrollment, pre-Baseline)
Enrollment
\[Aim 2\] Number of patients enrolled per month. Benchmark: ≥3 per month
Time frame: Upon enrollment
Retention in trial
\[Aim 2\] Percent of participants retained at each assessment time point (3 weeks, 3 months, 6 months, by assigned condition. Benchmark: ≥80% at each time point
Time frame: At 3-week timepoint, 3-month timepoint, 6-month timepoint
Days of cannabis use
\[Aim 3\] Number of cannabis use days measured on Timeline Follow-Back (TLFB) calendar
Time frame: At Baseline, 3-week timepoint, 3-month timepoint, 6-month timepoint
Times of cannabis use
\[Aim 3\] Number of cannabis use times measured on TLFB calendar
Time frame: At Baseline, 3-week timepoint, 3-month timepoint, 6-month timepoint
Negative consequences of cannabis use
\[Aim 3\] Number of negative consequences (problems) measured on the 19-item Marijuana Problems Scale
Time frame: At Baseline, 3-month timepoint, 6-month timepoint
Therapeutic alliance
\[Aim 1\] Working Alliance Inventory - Short Form, 12-items, 5-point Likert-type scale, total scale score and subscale scores (affective bond, perceived agreement on tasks, perceived agreement on goals; 4 items each), participant ("client") and observer versions reported separately and tested for agreement. Benchmark: ≥80% of participants with total score ≥48 (mean item score ≥4), participant version
Time frame: At week 1
MET counselor adherence to MI principles
\[Aim 1\] Measure of counselor adherence to MI principles in each MET session, as reported by participant. Sessions assessed with 7- to 9-item 5-point Likert-type scales (Strongly Disagree to Strongly Agree) developed for the study. Benchmark for each scale: ≥80% of participants with mean item score ≥4 out of 5
Time frame: At week 0 and week 1
Duration of study activities
\[Aim 2\] Duration of each study activity (in minutes)
Time frame: 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
\[Aim 3\] Symptom count measured by the Composite International Diagnostic Interview - Substance Abuse Module (CIDI-SAM)
Time frame: At Baseline, 3-month timepoint, 6-month timepoint
Amount of THC used
\[Aim 3\] Number of standard THC units (1 unit = 5 mg THC) derived from number of familiar units (joints, vapes, gummies, etc.) x amount per unit (grams, milligrams, or milliliters) x estimated potency (% THC), measured on TLFB calendar. If unable to calculate standard THC units: Number of familiar units (joints, vapes, gummies, etc.)
Time frame: At Baseline, 3-week timepoint, 3-month timepoint, 6-month timepoint
Motivation to change cannabis use
\[Aim 3\] One item each assessing readiness to, importance of, and confidence to change cannabis use, developed and used in our prior research, 11-point Likert-type scale for each. On follow-up, modified items about maintaining behavior if participant reports having started to change behavior but not having achieved change goals, or having changed behavior and achieved goals.
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Time frame: At Baseline, week 0, week 1, 3-months, 6-months
Psychological distress
\[Aim 3\] Kessler Psychological Scale-6 (K6), assessing frequency of experiencing 6 symptoms in the past month on a 5-point Likert-type scale, with coding such that high scores indicate greater psychological distress.
Time frame: At Baseline, 3-month timepoint, 6-month timepoint
Cognitive function
\[Aim 3\] PROMIS Cognitive Function v.2.0 - Short Form 6a, 6 items, 5-point Likert-type response, measures participant-perceived cognitive deficits in the past 7 days. Age- and gender-weighted T scores, higher T-scores indicating better cognitive function.
Time frame: At Baseline, 3-month timepoint, 6-month timepoint
Quality of life
\[Aim 3\] PROMIS Global Health v1.2, a 10-item, 5-point Likert-type response (except pain item 0-10), participant-reported measure of physical, mental, and social health, in general except for past 7 days for emotional problems, fatigue, and pain. Age- and gender-weighted T scores, higher T-scores indicating better quality of life.
Time frame: At Baseline, 3-month timepoint, 6-month timepoint