Bipolar Disorder Clinical Trial
Official title:
Modeling Mood Course to Detect Markers for Effective Adaptive Interventions- Aim 3
Verified date | December 2021 |
Source | University of Wisconsin, Madison |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | October 21, 2020 |
Est. primary completion date | October 21, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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: - |
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan | Ann Arbor | Michigan |
Lead Sponsor | Collaborator |
---|---|
University of Wisconsin, Madison | National Institute of Mental Health (NIMH), University of Michigan |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) |
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