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

University of Wisconsin (UW)

Status and phase: Completed; Phase 1

Conditions: Psychosocial Intervention; Bipolar Disorder

Treatments: Behavioral: Mobile intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04098497

Biostat & Med (Other Identifier)

7K01MH112876-02 (U.S. NIH Grant/Contract)

A538500 (Other Identifier)

2017-1322 Aim-3

SMPH/POP HEALTH SCI/POP HEALTH (Other Identifier)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

ACT-based microintervention delivered by mobile app

Experimental group

Description:

At every time-point of the study, participants will complete self-reports of mania (as measured by the shortened YMRS), depression (as measured by the shortened SIGH-D ), medication adherence, and activity through the mobile app Lorevimo. After completing these assessments, participants will be randomly assigned to either receive one additional ACT-based microintervention question or receive no additional question. 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). The ACT-based questions were developed by the research team as a unique intervention for the current study. They are based upon core themes of acceptance and commitment therapy: engagement, awareness, and openness.

Treatment:

Behavioral: Mobile intervention