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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04098497
Recruitment Status : Recruiting
First Posted : September 23, 2019
Last Update Posted : December 4, 2019
Sponsor:
Collaborators:
University of Michigan
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of Wisconsin, Madison

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.

Condition or disease Intervention/treatment Phase
Bipolar Disorder Psychosocial Intervention Behavioral: Mobile intervention Phase 1

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
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.

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Modeling Mood Course to Detect Markers for Effective Adaptive Interventions- Aim 3
Actual Study Start Date : September 13, 2019
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

Arm Intervention/treatment
Experimental: ACT-based microintervention delivered by mobile app

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

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.





Primary Outcome Measures :
  1. Feasibility of microintervention: average completion of shortened YMRS [ Time Frame: Days 1-43 ]

    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.

    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.

    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

  2. Feasibility of microintervention: average completion of shortened SIGH-D [ Time Frame: Days 1-43 ]

    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.

    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

  3. Safety of microintervention: change in YMRS score [ Time Frame: Day 0, Day 42 ]

    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.


  4. Safety of microintervention: change in SIGH-D score [ Time Frame: Day 0, Day 42 ]

    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.



Secondary Outcome Measures :
  1. Proximal changes in mood outcomes as a result of intervention: shortened YMRS score [ Time Frame: Days 1-43 ]

    The effectiveness of the ACT micro-intervention will be assessed by looking at the shortened YMRS score in relation to whether or not a participant received a micro-intervention at the prior time-point.

    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.

    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

  2. Proximal changes in mood outcomes as a result of intervention: shortened SIGH-D score [ Time Frame: Days 1-43 ]

    The effectiveness of the ACT micro-intervention will be assessed by looking at the shortened SIGH-D score in relation to whether or not a participant received a micro-intervention at the prior time-point.

    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

  3. Proximal changes in mood outcomes as a result of intervention: activity questionnaire [ Time Frame: Days 1-43 ]

    The effectiveness of the ACT micro-intervention will be assessed by looking at responses to the activity questionnaire in relation to whether or not a participant received a micro-intervention at the prior time-point. The activity questions of interest are as follows:

    1. Since you [woke this morning or last logged your symptoms], how much energy was consumed by trying to get rid of unwanted feelings, thoughts, or other internal experiences (example: suppressing, distracting, avoiding)?
    2. Since you [woke this morning or last logged your symptoms], how much energy was consumed by pursuing your values (example: making choices that align with who you want to be or who/what matters)?

    Both questions are answered using a scale of 0-6, where 0 = "none" and 6 = "all of my energy."




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04098497


Contacts
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Contact: Amy Cochran, PhD (608) 262-0772 cochran4@wisc.edu
Contact: Sydney Hoel shoel@wisc.edu

Locations
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United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Amy Cohcran, PhD       acochran4@wisc.edu   
Sponsors and Collaborators
University of Wisconsin, Madison
University of Michigan
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Melvis Mclnnis, MD University of Michigan, Ann Arbor, MI

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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT04098497    
Other Study ID Numbers: 2017-1322 Aim-3
Biostat & Med ( Other Identifier: UW, Madison )
7K01MH112876-02 ( U.S. NIH Grant/Contract )
A538500 ( Other Identifier: UW Madison )
SMPH/POP HEALTH SCI/POP HEALTH ( Other Identifier: UW Madison )
First Posted: September 23, 2019    Key Record Dates
Last Update Posted: December 4, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Wisconsin, Madison:
mood
stress
sleep
circadian rhythm
medical adherence
acceptance and commitment therapy
microintervention
Additional relevant MeSH terms:
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Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders