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

NCT04098497 | Completed Phase 1 Results

• 5 other identifiers: 2017-1322 Aim-3Biostat & Med7K01MH112876-02A538500SMPH/POP HEALTH SCI/POP HEALTH
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Disorder; Psychosocial Intervention

Keywords

mood; stress; sleep; circadian rhythm; medical adherence; acceptance and commitment therapy; microintervention

Outcome Measures

Primary Outcomes (4)

• Number of Shortened YMRS Surveys Completed

  Feasibility of the microintervention will be evaluated by measuring the average completion of the shortened Young Mania Rating Scale (YMRS) that will be delivered to participants through the mobile app. Number of completed surveys is reported. The Young Mania Rating Scale (YMRS) is a 11-item interview-based measure of manic symptoms. Scores on 3 items range from 0 to 8, whereas scores on the remaining 8 items range from 0 to 4. The total score of the YMRS can range from 0 to 60, with higher scores indicating more severe manic symptoms. The shortened scale used for the app includes three items (tracking the symptoms increased energy, rapid speech, and irritability) from the YMRS. The symptoms are scored on the following 0-3 scale: 0 = absent/normal 1. = mild 2. = moderate 3. = severe

  Days 1-43

• Number of Shortened SIGHD Surveys Completed

  Feasibility of the microintervention will be evaluated using the average completion of the shortened Structured Interview Guide for the Hamilton Depression Rating Scale (SIGH-D) that will be delivered to participants through the mobile app. Number of completed surveys is reported. The SIGH-D is a 17-item clinician-rated scale that assesses the severity of depressive symptoms. The total score is obtained by summing the score of each item, 0-4 (symptom is absent, mild, moderate, or severe) or 0-2 (absent, slight or trivial, clearly present). Scores can range from 0 to 54, with higher scores indicating more severe depression. The shortened SIGH-D assessment contains three items that track symptoms of depressed mood, fidgeting, and fatigue. The symptoms are scored on the following 0-3 scale: 0 = absent/normal 1. = mild 2. = moderate 3. = severe

  Days 1-43

• Change in YMRS Score

  The safety of the microintervention will be assessed by examining the change in YMRS scores from the beginning of the study (YMRS administered in entrance interview) to the end (YMRS administered again in exit interview). The Young Mania Rating Scale (YMRS) is a 11-item interview-based measure of manic symptoms. Scores on 3 items range from 0 to 8, whereas scores on the remaining 8 items range from 0 to 4. The total score of the YMRS can range from 0 to 56, with higher scores indicating more severe manic symptoms.

  Day 0, Day 42

• Change in SIGH-D Score

  The safety of the microintervention will be assessed by examining the change in SIGH-D scores from the beginning of the study (SIGH-D administered in entrance interview) to the end (SIGH-D administered again in exit interview). The SIGH-D is a 17-item clinician-rated scale that assesses the severity of depressive symptoms. The total score is obtained by summing the score of each item, 0-4 (symptom is absent, mild, moderate, or severe) or 0-2 (absent, slight or trivial, clearly present). Scores can range from 0 to 54, with higher scores indicating more severe depression.

  Day 0, Day 42

Secondary Outcomes (4)

• Average Change in m Score on digiBP From One Decision Time Point to the Next Decision Time Point as a Result of the Intervention

  data collected twice daily over 42 days (Days 1-43)

• Average Change in d Score on digiBP From One Decision Time Point to the Next Decision Time Point as a Result of the Intervention

  data collected twice daily over 42 days (Days 1-43)

• Average Change in Toward Energy Score From One Decision Time Point to the Next Decision Time Point as a Result of the Intervention

  data collected twice daily over 42 days (Days 1-43)

• Average Change in Away Energy Score From One Decision Time Point to the Next Decision Time Point as a Result of the Intervention

  data collected twice daily over 42 days (Days 1-43)

Study Arms (1)

ACT-based microintervention delivered by mobile app

EXPERIMENTAL

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.

Behavioral: Mobile intervention

Interventions

Mobile intervention BEHAVIORAL

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.

ACT-based microintervention delivered by mobile app

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals diagnosed with Bipolar Disorder
• have agreed to be contacted for future research
• have a smart-phone
• have a diagnosis of bipolar disorder.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• University of Michigan: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (2)

• Cochran A, Maronge JM, Victory A, Hoel S, McInnis MG, Thomas EB. Mobile Acceptance and Commitment Therapy in Bipolar Disorder: Microrandomized Trial. JMIR Ment Health. 2023 Apr 20;10:e43164. doi: 10.2196/43164.

  PMID: 37079363 DERIVED

• 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.

  PMID: 32965227 DERIVED

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Results Point of Contact

• Title: Amy Cochran
• Organization: University of Wisconsin - Madison

cochran4@wisc.edu

(608) 262-0772

Study Officials

• Melvis Mclnnis, MD

  University of Michigan, Ann Arbor, MI

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 19, 2019
• First Posted: September 23, 2019
• Study Start: September 13, 2019
• Primary Completion: October 21, 2020
• Study Completion: October 21, 2020
• Last Updated: January 3, 2022
• Results First Posted: January 3, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)