Effects of Adherence Therapy on Medication Adherence in Patients With Schizophrenia Spectrum Disorder: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Medication Adherence Rating Scale
研究概览
简要总结
This study will explore the effect of Adherence Therapy(AT) on medication adherence in patients with schizophrenia spectrum disorder.
详细描述
A single-blind, randomized controlled trial with a repeated-measures, two parallel groups design will be conducted for 120 participants with schizophrenia spectrum in regional hospital in northern Taiwan. After baseline data collection finished, the blocked randomization will be employed to assign participants to two groups. The experimental group will participate in a eight session course of Adherence Therapy. The control group received routine care. The data will be collected for baseline(T0) and after 4 session interim analysis(T1；9-12 weeks) and 8 session after intervention(T2；21-28 weeks). A structured Questionnaire will use to collect data on the Medication Adherence Rating Scale, Schedule for the Assessment of Insight, Internalized Stigma of Mental Illness Scale, Self-Appraisal of Illness Questionnaire and Positive and Negative Syndrome Scale. Data analysis will employ Statistical Package for the Social Sciences 20.0 with Generalized estimating equations approach to examine effects of Adherence Therapy and routine care on medication adherence.
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 (Participant)
入排标准
- 年龄范围
- 20 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 20-64
- •were Chinese speaking or Taiwanese speaking;
- •diagnosed with schizophrenia or schizoaffective disorder
- •recent history of non-adherence to antipsychotic medication.
- •Non-adherence to medication was defined as a recent history of cessation of psychiatric admission for more than one month at a time
- •The patient recently (half year) relapse of mental illness
- •Family and Health care worker state that the patient has taken irregular medication
- •demonstrated cognitive understanding of the research plan and provided consent.
排除标准
- •discharged from hospital for at least 3 months
- •no intellectual disability, organic brain diseases or Cognitive impairment
- •no alcohol or sub-stance abuse problems
- •were not attending medication management program .
研究组 & 干预措施
experimental group
The experimental group will participate in a eight session course of Adherence Therapy
干预措施: Adherence Therapy (Behavioral)
control group
The control group received routine care
干预措施: control group (Behavioral)
结局指标
主要结局
Medication Adherence Rating Scale
时间窗: for two study groups at baseline(T0) and after 4 session interim analysis (T1；9-12 weeks) and 8 session after intervention (T2；21-28 weeks).
The Medication Adherence Rating Scale was developed by Thompson et al. (2000). It evaluates the adherence behavior and attitude of the patient within the previous week. There are 10 close-ended questions (yes/no answers) in the questionnaire.
次要结局
- Schedule for the Assessment of Insight, SAI(for two study groups at baseline(T0) and after 4 session interim analysis(T1；9-12 weeks) and 8 session after intervention(T2；21-28 weeks).)
- Self-Appraisal of Illness Questionnaire, SAIQ(for two study groups at baseline(T0) and after 4 session interim analysis(T1；9-12 weeks) and 8 session after intervention(T2；21-28 weeks).)
- Positive and Negative Syndrome Scale, PANSS(for two study groups at baseline(T0) and after 4 session interim analysis(T1；9-12 weeks) and 8 session after intervention(T2；21-28 weeks).)