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临床试验/NCT02391649
NCT02391649已完成不适用

A Randomized Controlled Trial of Problem-solving Based Bibliotherapy Program for Family Caregivers of People With Psychotic Disorders

Chinese University of Hong Kong2 个研究点 分布在 1 个国家目标入组 422 人开始时间: 2014年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
422
试验地点
2
主要终点
Perceived burden of care (Chinese version of the 25-item Family Burden Interview Schedule)

研究概览

简要总结

This proposed randomized controlled trial will test the effectiveness of a problem-solving based bibliotherapy program (PSBBP) for Chinese family caregivers in psychotic disorders (not more than 5 years onset). A repeated-measures, three-group design will be used to evaluate and compare the effects between two treatment groups(PSBBP and psycho-education group) and routine outpatient service and family support (control group) for 198 randomly selected family caregivers of outpatients with psychotic disorders over a 24-month follow-up.

Before the 3-arm trial to be conducted, a pilot parallel-group randomised controlled trial with a similar study design to the later three-arm randomised controlled trial (Phase 2) will be conducted at one psychiatric outpatient clinic in Hong Kong. Receiving an additional funding from local government, another pilot two-arm trial will also be conducted for family caregivers of people with first-episode psychosis in the community to support and inform the 3-arm randomised controlled trial.

详细描述

Family caregivers of people with psychotic disorders are confronted by a various physical, psychosocial and financial hardships. This can adversely affect family members' caregiving experiences, psychological distress, general well-being, and family relationships or emotional involvement, which in turn may contribute to a greater risk of patient relapse and non-recovery. While family psycho-education and mutual support groups are effective in reducing caregivers' burden of care, these approaches usually require regular meetings and encounter difficulties in extensive training of group leaders/facilitators and engaging participants to actively share their caregiving experiences due to time inconvenience and fear/inability of expression of feelings. By virtue of the above, an alternate model of self-help program in book form named bibliotherapy, which is a guided reading and self-practice program with problem-solving training facilitated by a psychiatric nurse, has recently demonstrated evidences in clinical trials for families of depressive and psychotic patients by the research team, and other researchers.

In phase 1, a pilot randomised controlled trial with repeated measures, parallel-group (2-arm) design will be carried out at one psychiatric clinic. This pilot trial aims to evaluate the effects between the treatment group (i.e., a problem-solving based self-learning program) and routine outpatient service (control group) for 116 randomly selected family caregivers of outpatients with recent-onset psychosis over a 6-month follow-up. The study outcomes include the caregivers' burden of care, caregiving experiences, and problem-solving abilities, and the patients' mental state, functioning, and re-hospitalization rates. They will be measured at recruitment, one week, and 6 months following the interventions.

Another pilot controlled trial will recruit 116 families of people with first-episode psychosis attending follow-up at two regional psychiatric outpatient clinics in Hong Kong. Participant will be randomly selected in equal proportion from the two clinics under study and after baseline measures, the participants will be randomised to the treatment (i.e., the Chinese version of the original manual of bibliotherapy program) or the routine care. They will also be measured with the similar outcomes at the above pilot study at recruitment, one week, 6 months, and 12 months post-intervention.

In phase 2, a 3-arm randomized controlled trial will be conducted to test the effectiveness of the problem-solving based bibliotherapy program (PSBBP) for Chinese family caregivers in early stage of psychotic disorders. A repeated-measures, three-group design will be used to evaluate and compare the effects between two treatment groups (PSBBP and psycho-education group) and routine outpatient service and family support (control group) for 198 randomly selected family caregivers of outpatients with psychotic disorders over a 24-month follow-up. Primary outcomes include caregivers' burden of care, caregiving experiences and coping and social problem-solving skills using validated instruments. Secondary outcomes are patients' mental state, functioning, perceived expressed emotion, and re-hospitalization rate. They will be measured at recruitment, one week, and 12 and 24 months following the interventions. It is hypothesized that the PSBBP participants will produce significantly better improvements in caregivers' perceived burden, caregiving experience and coping and problem-solving skills than those in psycho-education and control groups over 24-month follow-up.

Focus group interviews will be conducted after the first post-test with 20 caregivers (10 participants per group) in both treatment groups. Their data will be content analyzed to identify their perceived benefits, limitations and difficulties encountered and therapeutic ingredients of the two programs.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

盲法说明

Outcome assessors are blind to the group assignment and intervention undertaken and concealed to the participant list.

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Perceived burden of care (Chinese version of the 25-item Family Burden Interview Schedule)

时间窗: 24 months (for Phase 2 only) after completion of intervention

Caregivers' perceived burden of care will be measured by a Chinese version of the 25-item Family Burden Interview Schedule.

Coping style (42-item Revised Ways of Coping Checklist)

时间窗: 24 months (for Phase 2 only) after completion of intervention

A Chinese version of Coping style of the caregivers style will be assessed using the 42-item Revised Ways of Coping Checklist.

次要结局

  • Experience of caregiving (Chinese version of Experience of Caregiving Inventory)(24 months (Phase 2; 6 and 12 months for Phase 1) after completion of intervention)
  • Social Problem-Solving (Chinese version of Revised (Short) Social Problem-Solving Inventory)(24 months (Phase 2; 6 and 12 months for Phase 1) after completion of intervention)
  • Mental state (Positive and Negative Syndrome Scale)(24 months (Phase 2; 6 and 12 months for Phase 1) after completion of intervention)
  • Patient functioning (43-item Specific Level of Functioning Scale)(24 months (Phase 2; 6 and 12 months for Phase 1) after completion of intervention)
  • Perceived expressed emotion (Level of Expressed Emotion scale; used in Phase 2 only)(24 months after completion of intervention)
  • Rate and length of re-hospitalizations(24 months (Phase 1; 6 and 12 months for Phase 1) after completion of intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Wai Tong CHIEN

Professor

Chinese University of Hong Kong

研究点 (2)

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