NCT05824754

Brief Summary

This study is being completed to pilot prevention methods to promote wellness and reduce risky behaviors, including the use of substances such as cannabis. This study will help researchers learn about ways of delivering this information that is both appealing and helpful to young adults who use mobile apps.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 6, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 24, 2023

Completed
10 months until next milestone

Study Start

First participant enrolled

February 21, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 28, 2024

Completed
1 year until next milestone

Results Posted

Study results publicly available

June 12, 2025

Completed
Last Updated

June 12, 2025

Status Verified

June 1, 2025

Enrollment Period

3 months

First QC Date

April 6, 2023

Results QC Date

May 12, 2025

Last Update Submit

June 10, 2025

Conditions

Keywords

Cannabis UseMarijuanaSubstance-Related DisordersMental Disorders

Outcome Measures

Primary Outcomes (2)

  • App Feasibility

    % of participants who consented to the study who download the MiWaves app.

    1 month

  • App Acceptability

    Participants will complete acceptability ratings for the MiWaves app within their post-test assessment (percent with positive rating).

    1 month

Study Arms (1)

JITAI

EXPERIMENTAL

Experimental: Within-participant micro-randomization Twice daily in the study, a participant is assigned to receive a message or no message. The micro-randomization will be performed by a reinforcement learning algorithm based on the participant's engagement with the intervention.

Other: Just-In-Time-Adaptive-Intervention (JITAI)

Interventions

Behavioral: MiWaves behavioral messages Participants will be using the MiWaves mobile app for 30 days. When a participant is assigned to receive a message, a message will be randomly selected from a pool of intervention message sets. Messages are based in motivational interviewing and include affect management and behavioral economic strategies.

JITAI

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Reside in the US
  • Speak and read English
  • Have a smartphone on which the app can be downloaded
  • Screen positive for cannabis use 3 or more times each week over the past month
  • Report motivation to change cannabis as 1 or higher (using scale of 0-10)
  • Meet Study verification criteria (i.e., use of CAPTCHA, IP address checks)

You may not qualify if:

  • Use of Medical Cannabis
  • Failure to meet study verification criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Marijuana AbuseSubstance-Related DisordersMental Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Results Point of Contact

Title
Inbal Billie Nahum-Shani
Organization
University of Michigan

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 6, 2023

First Posted

April 24, 2023

Study Start

February 21, 2024

Primary Completion

May 28, 2024

Study Completion

May 28, 2024

Last Updated

June 12, 2025

Results First Posted

June 12, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations