NCT04098497

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Bipolar (BP) disorder is a chronic illness of profound shifts in mood ranging from mania to depression. BP is successfully treated by combining medication with psychosocial therapy, but care can prove inadequate in practice. With gaps in coverage and medication, along with imprecise guidelines on when, where, and how to intervene, promising psychosocial therapies require adaptive strategies to better address the specific needs of individuals in a timely manner. However, To accomplish this, evidence based practices are needed. This project aims to address this knowledge gap by establishing a mobile health platform for translating a psychosocial therapy in BP into an effective adaptive intervention. The research to be conducted under this protocol falls under the general heading of a micro-randomized trial. It investigates feasibility of a study on how to tailor an intervention based on acceptance and commitment therapy (ACT) when delivered via a smartphone app. Long-term objective of this study is to develop a mobile health platform for the translation of a psychosocial intervention for bipolar disorder (BP) into an effective adaptive intervention. In this particular part of the study, the investigator will assess the feasibility of a mobile health and wearable device platform for the translation of a BP psychosocial therapy into an evidenced-based adaptive intervention. To answer this question, investigator will study how individuals with BP respond to a microintervention delivered via a mobile app. Primary outcome of this study is to evaluate the feasibility of a micro-randomized trial in ACT in terms of completion of assessments (interview and self-report), wearing of Fitbit, and completion of microintervention questions. Secondary outcome of the study is to detect a linear effect in time of the microintervention on symptom levels of mania and depression in individuals with bipolar disorder. The estimated linear effect would be used to power a larger study.Enrollment is by invitation only; participants in the study will be recruited from the Prechter Longitudinal Study of Bipolar Disorder (HUM606).

Conditions

• Bipolar Disorder
• Psychosocial Intervention

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-09-13
• Primary completion: 2020-10-21
• Completion: 2020-10-21
• First posted: 2019-09-23
• Last updated: 2022-01-03
• Results posted: 2022-01-03

Locations

1 site across 1 country: United States