Phase 1
N=30
Modeling Mood Course to Detect Markers for Effective Adaptive Interventions- Aim 3
Bipolar Disorder · Psychosocial Intervention
Bottom Line
View on ClinicalTrials.gov: NCT04098497 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Jan 2022
Primary outcome: Primary: Number of Shortened YMRS Surveys Completed — 1651 completed surveys
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Mobile intervention (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Wisconsin, Madison
- Primary completion
- Oct 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Shortened YMRS Surveys Completed |
1651 | — |
| PRIMARY Number of Shortened SIGHD Surveys Completed |
1651 | — |
| PRIMARY Change in YMRS Score |
-1.2 | 0.09 |
| PRIMARY Change in SIGH-D Score |
2.1 | 0.09 |
| SECONDARY Average Change in m Score on digiBP From One Decision Time Point to the Next Decision Time Point as a Result of the Intervention |
0.14 | 0.13 |
| SECONDARY Average Change in d Score on digiBP From One Decision Time Point to the Next Decision Time Point as a Result of the Intervention |
0.38 | 0.007 sig |
| SECONDARY Average Change in Toward Energy Score From One Decision Time Point to the Next Decision Time Point as a Result of the Intervention |
0.03 | 0.57 |
| SECONDARY Average Change in Away Energy Score From One Decision Time Point to the Next Decision Time Point as a Result of the Intervention |
0.06 | 0.25 |
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.
Eligibility Criteria
Inclusion Criteria
- Individuals diagnosed with Bipolar Disorder
- have agreed to be contacted for future research
- have a smart-phone
- have a diagnosis of bipolar disorder.
Exclusion Criteria
-
Data sourced from ClinicalTrials.gov (NCT04098497). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.