Developing a Telehealth + MHealth Cannabis Use Intervention for Young Adults

Not Applicable

• Conditions: Cannabis Use Disorder

• Registration Number: NCT06661031
• Lead Sponsor: Boston Children's Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-22
• Study First Submitted QC: 2024-10-24
• Study First Posted: 2024-10-28
• Study Start: 2024-12-10
• Last Update Submitted: 2024-12-13
• Last Update Posted: 2024-12-18
• Primary Completion: 2027-05
• Study Completion: 2027-05

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 65

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

Exclusion Criteria

• 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 ≥12
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Intervention completion	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	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	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	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	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	During recruitment (upon completion of eligibility survey: pre-enrollment, pre-Baseline)	\[Aim 2\] Number of patients eligible per month. Benchmark: ≥6 per month
Enrollment	Upon enrollment	\[Aim 2\] Number of patients enrolled per month. Benchmark: ≥3 per month
Retention in trial	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
Days of cannabis use	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
Times of cannabis use	At Baseline, 3-week timepoint, 3-month timepoint, 6-month timepoint	\[Aim 3\] Number of cannabis use times measured on TLFB calendar
Negative consequences of cannabis use	At Baseline, 3-month timepoint, 6-month timepoint	\[Aim 3\] Number of negative consequences (problems) measured on the 19-item Marijuana Problems Scale

Secondary Outcome Measures

Name	Time	Method
Therapeutic alliance	At week 1	\[Aim 1\] 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
MET counselor adherence to MI principles	At week 0 and week 1	\[Aim 1\] 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
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)	\[Aim 2\] Duration of each study activity (in minutes)
Cannabis use disorder (CUD) symptoms	At Baseline, 3-month timepoint, 6-month timepoint	\[Aim 3\] Symptom count measured by the Composite International Diagnostic Interview - Substance Abuse Module (CIDI-SAM)
Amount of THC used	At Baseline, 3-week timepoint, 3-month timepoint, 6-month timepoint	\[Aim 3\] 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.)
Motivation to change cannabis use	At Baseline, week 0, week 1, 3-months, 6-months	\[Aim 3\] 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.
Psychological distress	At Baseline, 3-month timepoint, 6-month timepoint	\[Aim 3\] 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.
Cognitive function	At Baseline, 3-month timepoint, 6-month timepoint	\[Aim 3\] 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.
Quality of life	At Baseline, 3-month timepoint, 6-month timepoint	\[Aim 3\] 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.

Trial Locations

Locations (1)

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States