Customized Adherence Enhancement in Bipolar Disorder (CAE in BD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Change in Treatment Adherence as Measured by the Morisky Scale
研究概览
简要总结
In this study, patients with bipolar disorder who do not take their medications as prescribed will receive specialized education and therapy treatment to determine whether the specialized treatment is effective in helping patients to take their medications consistently.
详细描述
Bipolar disorder (BPD) is a chronic disorder characterized by manic and depressive episodes that disrupt healthy, functional lives. Despite recent advances in medication treatments, many BPD patients do not take their medications. Medication nonadherence is associated with multiple risks, such as relapse, rehospitalization, lengthier hospital stays, and, in some cases, increased risk of suicide. Some studies have shown that treatment adherence in BPD can be improved, particularly through psychological education, development of self-management strategies or behaviors, and ongoing relapse prevention.
This study will examine the effectiveness of medication adherence treatment modules specialized to deal with specific reasons for nonadherence. Participants, all of whom have a history of medication nonadherence, will undergo structured interviews and complete self-report questionnaires to determine individual reasons for nonadherence. Based on their individual profiles, participants will be assigned to one or more of the following intervention modules:
- Psychoeducation: This module uses education about BPD and related treatment to address patient issues such as opposition to preventive efforts, denial of the need for or effectiveness of medication, negative attitudes toward drugs in general, lack of information about mood stabilizers, and stigma or embarrassment related to BPD treatment.
- Substance abuse: This module targets substance abuse problems that interfere with medication adherence.
- Communication with providers: This module addresses fear of medication side effects by improving communication with health care providers.
- Medication routines management: This module addresses difficulties establishing a medication routine and outside opposition to medications by developing strategies for consistent medication adherence routines.
Each module will involve four 60-minute sessions conducted in a 4- to 6-week period. The study therapist will conduct each of these sessions individually with the participant, combining or coadministering modules in a single session if participants are assigned to more than one module. Depending on which module or modules participants are assigned to, they may also be contacted by phone one to three times by the therapist to complete all module materials.
This study will be conducted in two phases. In the first, an initial group of participants will undergo the module treatments and then participants and therapists will be interviewed about the effectiveness and feasibility of the interventions. This feedback will be used to refine the modules. In the second phase, a second group of participants will undergo treatment in the refined modules and provide more feedback. All participants will continue with their regular treatment while undergoing module treatments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Clinical diagnosis of bipolar disorder (BPD) Type I or Type II, as determined by a standardized diagnostic interview, the Mini-International Neuropsychiatric Interview (MINI)
- •Demonstrated history of poor medication adherence, as determined by self-report or clinician report. In this study, self-reported treatment nonadherence will be identified with the Tablet Routines Questionnaire (TRQ). Poorly adherent individuals will be defined as those who miss 30% or more of medication within either the past week or past month (those missing 30% or more within past week will be considered to be nonadherent over the past month). Clinician-assessed nonadherence will be identified via a clinician version of the TRQ to identify nonadherence of 30% or more over the past 30 days.
- •BPD of at least 2 years' duration
- •Treatment with medication to stabilize mood for at least 6 months
排除标准
- •Unable/unwilling to participate in psychiatric interviews, as based on the clinical opinion of the investigator or the treating clinician
- •High risk of suicide, as seen in factors such as active suicidal ideation, recent suicide attempt, or current intent or plan
- •Inability to speak English
- •Individuals who have participated in Project 1, Personal Adherence Evaluation of Individuals Receiving Treatment for Bipolar Disorder (PAE in BD)
结局指标
主要结局
Change in Treatment Adherence as Measured by the Morisky Scale
时间窗: baseline and 6 months
The minimum score is 0 and the maximum score is 4. A higher score implies poorer treatment adherence.
Change in Treatment Adherence Within the Past Month as Measured by the Tablet Routines Questionnaire
时间窗: baseline and 3 months
The minimum score is 0 and the maximum score is 100. A higher score implies poorer treatment adherence.
Change in Treatment Adherence Within the Past Week as Measured by the Tablet Routines Questionnaire
时间窗: baseline and 3 months
The minimum score is 0 and the maximum score is 100. A higher score implies poorer treatment adherence.
次要结局
- Change in Depression as Measured by the Hamilton Rating Scale for Depression (HAM-D)(baseline and 3 months)
- Change in Attitude as Measured by the Rating of Medication Influences (ROMI)(baseline and 3 months)
- Change in Perception of Physical Health as Measured by the 12-item Short Form Health Survey (SF-12)(baseline and 3 months)
- Change in Attitude as Measured by the Attitude Toward Mood Stabilizers Questionnaire (AMSQ)(baseline and 3 months)
- Change in Global Psychopathology as Measured by the Clinical Global Impression for Bipolar Disorder (CGI-BP)(baseline and 3 months)
- Change in Functional Status as Measured by the Global Assessment of Functioning (GAF) Scale(baseline and 3 months)
- Change in Perception of Mental Health as Measured by the 12-item Short Form Health Survey (SF-12)(baseline and 3 months)
- Change in Symptoms of Bipolar Disorder as Measured by the Young Mania Rating Scale (YMRS)(baseline and 3 months)
- Change in Symptoms of Bipolar Disorder as Measured by the Brief Psychiatric Rating Scale (BPRS)(baseline and 3 months)
研究者
Martha Sajatovic, MD
Professor of Psychiatry
Case Western Reserve University
