The Effect of a Theory Based Educational Intervention on Medication Adherence to and Removes of Related Barriers in Patients With Bipolar Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 270
- 试验地点
- 10
- 主要终点
- changes in Patient-reported medication Adherence to mood stabilizers
研究概览
简要总结
Despite an increasing pharmacopoeia of effective medications for the treatment of bipolar disorder, patient outcomes continue to be impacted by treatment adherence. Non-adherence to treatments is also a major obstacle in translating efficacy in research settings into effectiveness in clinical practice. Non-adherence with bipolar disorder (BD) medication treatment dramatically worsens outcomes. Reasons for non-adherence among individuals with BD are multi-dimensional, and it has been suggested that a multifaceted intervention will be more effective. The study is aimed to assess the effectiveness of a multifaceted intervention on enhancing medications adherence in patients with bipolar disorders.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •age ≥18 years
- •meeting DSM-IV criteria for bipolar I or II disorder
- •concurrently treated with a mood stabilizer
- •not currently in weekly or biweekly psychotherapy
- •Persian speaking.
排除标准
- •DSM-IV drug or alcohol misuse disorders (excluding nicotine),
- •pregnancy or planning pregnancy in the next year
- •requiring changing the drug or the dose of a mood stabilizer
- •evidence of severe DSM-IV borderline personality
- •Unable or unwilling to give written informed consent.
- •An organic cerebral cause for bipolar disorder-for example, multiple sclerosis or stroke.
- •intellectual disability
研究组 & 干预措施
Multifaceted intervention
Patients, their caregivers and family members will received the educational and motivational interventions
干预措施: Multifaceted intervention (Behavioral)
Active Comparator
Usual Care The usual care group received routine counseling performed by the psychiatrist and nurses.
干预措施: Routine counseling (Behavioral)
结局指标
主要结局
changes in Patient-reported medication Adherence to mood stabilizers
时间窗: changes from baseline, 1 Months and 6 months follow-up
The Medication Adherence Report Scale (MARS-5) will be used for assessing medication adherence to the mood stabilizers
次要结局
- Changes in Montgomery Asberg Depression Rating Scale(Changes from baseline, 1 Months and 6 months after the intervention)
- Plasma level of mood stabilizer(Changes from baseline, 1 Months and 6 months after the intervention)
- Changes in coping planning(Changes from baseline, 1 Months and 6 months after the intervention)
- Changes in Young Mania Rating Scale (YMRS)(Changes from baseline, 1 Months and 6 months after the intervention)
- Changes in action planning(Changes from baseline, 1 Months and 6 months after the intervention)
- Changes in quality of life(Changes from baseline, 1 Months and 6 months after the intervention)
- Changes in psychological predictors of medication adherence (intention, perceived behavioral control ,Self-monitoring and Behaviour Automaticity)(Changes from baseline, 1 Months and 6 months after the intervention)
- Changes in Global Impression for Bipolar Disorder Severity scale (CGI-BP-S)(Changes from baseline, 1 Months and 6 months after the intervention)
- Changes in Beliefs about Medicines Questionnaire (BMQ)(Changes from baseline, 1 Months and 6 months after the intervention)
研究者
Amir H Pakpour
Head of the Social Determinants of Health Research Center
Qazvin University Of Medical Sciences