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

NCT04098497 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-01-03

Study results available
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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.

Conditions

Interventions

BEHAVIORAL

Mobile intervention

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.

Sponsors & Collaborators

  • University of Michigan

    collaborator OTHER

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • University of Wisconsin, Madison

    lead OTHER

Principal Investigators

  • Melvis Mclnnis, MD · University of Michigan, Ann Arbor, MI

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-13
Primary Completion
2020-10-21
Completion
2020-10-21

Countries

  • United States

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04098497 on ClinicalTrials.gov