Clinical trial NCT04098497: Modeling Mood Course to Detect Markers for Effective Adaptive Interventions- Aim 3
Official title: Modeling Mood Course to Detect Markers for Effective Adaptive Interventions- Aim 3
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bipolar Disorder
Psychosocial Intervention
Keywords: mood
stress
sleep
circadian rhythm
medical adherence
acceptance and commitment therapy
microintervention
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: University of Michigan
name: National Institute of Mental Health (NIMH)
First posted: 2019-09-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: This study uses a design known as a microrandomized trial. Whereas a multi-arm trial randomizes a subject to an intervention group only once at the start of the study, a microrandomized trial repeatedly randomizes a subject to an intervention group throughout the study. In addition to an overall effect of an intervention on proximal outcomes, a microrandomized trial allows one to determine if the effect is modified by momentary factors (e.g., current mood, day of the week, day in the study).

For the present study, every subject has a equal chance of being assigned to one of two intervention groups at each of 84 time points (2 daily x 42 days). At each time point, the two intervention groups are to either receive a prompt based on Acceptance and Commitment Therapy (ACT) or not receive such a prompt. Regardless of the assigned group, subjects are asked to assess their mood, stress, and activity at every time point prior to assignment to intervention group.
Primary purpose: TREATMENT

Brief 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).

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:

-

Primary outcomes:
measure: Number of Shortened YMRS Surveys Completed
timeFrame: Days 1-43
measure: Number of Shortened SIGHD Surveys Completed
timeFrame: Days 1-43
measure: Change in YMRS Score
timeFrame: Day 0, Day 42
measure: Change in SIGH-D Score
timeFrame: Day 0, Day 42
Secondary outcomes:
measure: Average Change in m Score on digiBP From One Decision Time Point to the Next Decision Time Point as a Result of the Intervention
timeFrame: data collected twice daily over 42 days (Days 1-43)
measure: Average Change in d Score on digiBP From One Decision Time Point to the Next Decision Time Point as a Result of the Intervention
timeFrame: data collected twice daily over 42 days (Days 1-43)
measure: Average Change in Toward Energy Score From One Decision Time Point to the Next Decision Time Point as a Result of the Intervention
timeFrame: data collected twice daily over 42 days (Days 1-43)
measure: Average Change in Away Energy Score From One Decision Time Point to the Next Decision Time Point as a Result of the Intervention
timeFrame: data collected twice daily over 42 days (Days 1-43)
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan, Ann Arbor, MI
name: Melvis Mclnnis, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kroska EB, Hoel S, Victory A, Murphy SA, McInnis MG, Stowe ZN, Cochran A. Optimizing an Acceptance and Commitment Therapy Microintervention Via a Mobile App With Two Cohorts: Protocol for Micro-Randomized Trials. JMIR Res Protoc. 2020 Sep 23;9(9):e17086. doi: 10.2196/17086.