Exploring the Effect of Rumination-Focused Cognitive Behaviour Therapy on Depressive Symptoms in Patients With Schizophrenia: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Beck Depression Inventory (BDI-II)
研究概览
简要总结
This study will explore the effect of Rumination-Focused Cognitive Behaviour Therapy on depressive symptoms in patients with schizophrenia for three months. A randomized controlled trial is conducted in a psychiatric center in northern Taiwan. All participants are randomized to two groups using blocked randomization. The experimental groups are provided with a 6- session RFCBT program for 12 weeks (60-90 mins, once every two weeks), while the control groups receive a 6- session Health Education program for 12 weeks (60-90 mins, once every two weeks). All participants who suffered from depressive symptoms at both baseline and 3-month follow-up will be evaluated using the Beck Depression Inventory(BDI-II), Chinese Response Style Questionnaire-short form revised(CRSQ-10), Internalized Stigma of Mental Illness (ISMI) Scale, and Herth Hope Index Chinese Version(HHI).
详细描述
Background:
Depressive symptoms are one of the core symptoms in patients with schizophrenia, but the effect of depressive symptoms on patients is easily overlooked. Severe depressive symptoms in patients with schizophrenia are not only affecting the quality of life but also the risk factors of suicide.
Aim:
The investigators hypothesize that Rumination-Focused Cognitive Behaviour Therapy(RFCBT) could have significant effect of depressive symptoms. Therefore, in this study, the investigators will explore the effect of Rumination-Focused Cognitive Behaviour Therapy(RFCBT) on depressive symptoms in patients with schizophrenia.
Methods:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
The data of PANSS were collected by a research assistant.
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The participants are diagnosed with schizophrenia by Diagnostic and Statistical Manual of Mental Disorders, Five Edition (DSM-V), an age of between 20 and 65 years, hospitalization in a rehabilitation unit, and a stable condition at the time of data collection.
- •The participants are able to provide written informed consent and comprehend the instruments.
- •The participants consent to receive a 6- session RFCBT program or a 6- session Health Education program and complete a package of questionnaires.
- •The participants are satisfied the screening criteria including the Positive and Negative Syndrome Scale (PANSS) for positive syndromes < 5, the Mini-Mental State Examination (MMSE) ≥ 24, and the Brief Symptom Rating Scale (BSRS-5) ≥ 6.
排除标准
- •The participants who have intellectual disturbances (organic mental disorders) or substance abuse issues through a chart review.
- •The participants who are not willing to sign the consent.
结局指标
主要结局
Beck Depression Inventory (BDI-II)
时间窗: For two study groups, the measure time points are at baseline(T0), after intervention (T1) and three-month follow-up (T2).
The Beck Depression Inventory-II (BDI-II) is a 21-item self-report depression screening measure. Each item is rated on a four-point Likert-type scale ranging from 0 to 3, which with possible scores ranging from 0 to 63. The BDI-II has been translated into a Chinese version. Higher total scores indicate more severe depressive symptoms, and a score of \>16 points is considered suggestive of the presence of clinically significant depressive symptom intensity. In this study, the investigators will explore the change of BDI-II score among baseline, after intervention and three-month follow-up.
Chinese Response Style Questionnaire-short Form Revised (CRSQ-10)
时间窗: For two study groups, the measure time points are at baseline(T0), after intervention (T1) and three-month follow-up (T2).
The Chinese Response Style Questionnaire-short form revised (CRSQ-10) is a self-report measure of rumination, comprising ten items and describing the factors of brooding and reflection. Each item is rated on a four-point Likert-type scale ranging from 1 (strongly disagree) to 4 (strongly agree), which with possible scores ranging from 10 to 40. The CRSQ-10 has been used to evaluate the intensity of ruminative responses to depressed mood. In this study, the investigators will explore the change of CRSQ-10 score among baseline, after intervention and three-month follow-up.
次要结局
- The Internalized Stigma of Mental Illness (ISMI) Scale(For two study groups, the measure time points are at baseline(T0), after intervention (T1) and three-month follow-up (T2).)
- Herth Hope Index Chinese Version(HHI)(For two study groups, the measure time points are at baseline(T0), after intervention (T1) and three-month follow-up (T2).)
研究者
Chiu-Yueh Yang
Associate Professor, Nursing Department
National Yang Ming Chiao Tung University