CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 30 enrolled
Drug / intervention
Mobile interventionbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04098497
NCT04098497Phase 1Completed
CompareCT.gov

Modeling Mood Course to Detect Markers for Effective Adaptive Interventions- Aim 3

University of Wisconsin, Madison·interventional·Posted Sep 23, 2019·Updated Jan 3, 2022

In Brief

A Phase 1 clinical trial evaluating Mobile intervention for Bipolar Disorder and Psychosocial Intervention. Completed, enrolled 30 participants across 1 site.

Detailed Summary

This study is a 6-week micro-randomized trial investigating the feasibility of a mobile health platform. Its long-term objective is to develop a mobile health platform for the translation of a psychosocial intervention for bipolar disorder (BP) into an effective and evidence-based adaptive intervention. In this aim of the study, investigators will evaluate how individuals with BP respond to a microintervention based in acceptance and commitment therapy (ACT) that is delivered with a mobile app.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBipolar Disorder, Psychosocial Intervention
CountriesUnited States
CollaboratorsUniversity of Michigan, National Institute of Mental Health (NIMH)

Timeline

Phase 1CompletedFinished
2020202120222023202420252026
First PostedSep 23, 2019
Enrollment StartSep 13, 2019
Primary CompletionOct 21, 2020
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 6.8 years ago

Interventions

Mobile interventionbehavioral

The mobile intervention in this study consists of two components: 1) self-monitoring and 2) an ACT-based microintervention. Self-monitoring: twice daily, participants will complete self-reports of mania, depression, medication adherence, and activity through the mobile app Lorevimo. Microintervention: The microintervention will consist of one of 84 prompts that aim to target one of 6 processes targeted in ACT (contacting the present moment, defusion, acceptance, self-as-context, values, and committed action). At each time-point, participants have a 50% chance of receiving a microintervention question along with the daily self-monitoring assessments.