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

Study Overview
=================
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).

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

Conditions
-----------------
Bipolar Disorder, Psychosocial Intervention

Intervention / Treatment
-----------------
* Behavioral: Mobile intervention


Participation Criteria
=================
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: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ACT-based microintervention delivered by mobile app<br>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<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 = mild = moderate = 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 = mild = moderate = 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Change in m Score on digiBP From One Decision Time Point to the Next Decision Time Point as a Result of the Intervention | Mood was self-reported using the 6-item digital survey for mood in bipolar disorder (digiPB). This survey is comprised of 3 items (depressed mood, fatigue, fidgeting) measuring common depressive symptoms, two items (increased energy, rapid speech) measuring common manic symptoms, and one item (irritability) measuring a common symptom of both mania and depression. Each item is rated on ordinal scale: 0=absent/normal, 1=mild, 2=moderate, 3=severe. Two scores, d and m, are computed to measure severity of depressive and manic symptoms, respectively. The m score ranges from 0 to 18 with higher scores being most severe symptoms of mania. Self-reported mood was collected twice-daily over 42 days, once in the morning and once in the evening. This leads to a total of 84 decision time points. This outcome looks at the average change in the m score from one decision time point to the next (e.g., from morning to evening or from evening to the next morning) that is attributed to 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 | Mood was self-reported using the 6-item digital survey for mood in bipolar disorder (digiPB). This survey is comprised of 3 items (depressed mood, fatigue, fidgeting) measuring common depressive symptoms, two items (increased energy, rapid speech) measuring common manic symptoms, and one item (irritability) measuring a common symptom of both mania and depression. Each item is rated on ordinal scale: 0=absent/normal, 1=mild, 2=moderate, 3=severe. Two scores, d and m, are computed to measure severity of depressive and manic symptoms, respectively. D score ranges from 0 to 21, higher scores being most severe symptoms of depression. Self-reported mood was collected twice-daily over 42 days, once in the morning and once in the evening. This leads to a total of 84 decision time points. This outcome looks at the average change in the d score from one decision time point to the next (e.g., from morning to evening or from evening to the next morning) that is attributed to 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 | 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. 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)? Questions are answered using a scale of 0-6, where 0 = none and 6 = all of my energy. Self-reported toward energy was collected twice-daily over 42 days, once in the morning and once in the evening. This leads to a total of 84 decision time points. This outcome looks at the average change in toward energy from one decision time point to the next (e.g., from morning to evening or from evening to the next morning) that is attributed to 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 | 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. 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)? Questions are answered using a scale of 0-6, where 0 = none and 6 = all of my energy. Self-reported away energy was collected twice-daily over 42 days, once in the morning and once in the evening. This leads to a total of 84 decision time points. This outcome looks at the average change in away energy from one decision time point to the next (e.g., from morning to evening or from evening to the next morning) that is attributed to the intervention. | data collected twice daily over 42 days (Days 1-43) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mood, stress, sleep, circadian rhythm, medical adherence, microintervention, acceptance and commitment therapy