Modeling Mood Course to Detect Markers for Effective Adaptive Interventions- Aim 3
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Number of Shortened SIGHD Surveys Completed
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals diagnosed with Bipolar Disorder
- •have agreed to be contacted for future research
- •have a smart-phone
- •have a diagnosis of bipolar disorder.
排除标准
- 未提供
研究组 & 干预措施
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.
干预措施: Mobile intervention (Behavioral)
结局指标
主要结局
Number of Shortened SIGHD Surveys Completed
时间窗: 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. 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
Change in YMRS Score
时间窗: 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.
Number of Shortened YMRS Surveys Completed
时间窗: 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. 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
Change in SIGH-D Score
时间窗: 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.
次要结局
- 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 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))
- 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 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))