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ENQUIRE PROJECT DETAILS BY GENERAL PUBLIC |
| Project Details |
| Funding Scheme : | General Research Fund | ||||||||||||
| Project Number : | 15401114 | ||||||||||||
| Project Title(English) : | A Randomized Controlled Trial of Problem-solving Based Bibliotherapy Program for Family Caregivers of People with Schizophrenia Spectrum Disorders | ||||||||||||
| Project Title(Chinese) : | 對精神分裂症譜系障礙患者的家庭照顧者採用自助問題解決方式的『閱讀療法』之隨機對照實驗 | ||||||||||||
| Principal Investigator(English) : | Prof CHIEN, Wai Tong | ||||||||||||
| Principal Investigator(Chinese) : | |||||||||||||
| Department : | School of Nursing | ||||||||||||
| Institution : | The Hong Kong Polytechnic University | ||||||||||||
| E-mail Address : | wai.tong.chien@polyu.edu.hk | ||||||||||||
| Tel : | |||||||||||||
| Co - Investigator(s) : |
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| Panel : | Humanities, Social Sciences | ||||||||||||
| Subject Area : | Professional & Vocational Studies | ||||||||||||
| Exercise Year : | 2014 / 15 | ||||||||||||
| Fund Approved : | 488,784 | ||||||||||||
| Project Status : | Completed | ||||||||||||
| Completion Date : | 31-12-2016 | ||||||||||||
| Project Objectives : |
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| Abstract as per original application (English/Chinese): |
Family caregivers of people with schizophrenia-spectrum 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 and 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.
This proposed randomized controlled trial will test the effectiveness of a problem-solving based bibliotherapy program (PSBBP) for Chinese family caregivers in schizophrenia spectrum 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(controls with a self-help booklet) for 129 randomly selected family caregivers of outpatients with schizophrenia-spectrum disorders over a 12-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 6 and 12 months following the interventions. Kaplan-Meier survival analysis will be used to analyze the relative risks of re-hospitalizations amongst the treatment and control groups over 12-month follow-up. 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 12-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. With significant positive outcomes found in the PSBBP, this program will be adopted by community mental healthcare services in Hong Kong, and replicated in other Asian countries, to improve family-based care in schizophrenia-spectrum disorders. 撮要: 患有精神分裂症譜系障礙患者的家庭照顧者需要面對各種生理、心理、和經濟上的艱辛。這些辛酸不但對家庭成員造成精神困擾，而且影響他們生活質素和家庭成員之間的關係或感情，從而增加患者復發的風險，及妨礙患者康復。雖然家庭心理教育和互助小組能有效減少照顧者的心理和社交上的負擔，這些方法的困難在於必須定期舉行會議 ; 需要組長 (或主持) 接受一定程度的專業訓練 ; 並且要求參加者縱使時間不便及懼怕或無能力表達情感，仍需積極分享自己的照顧經驗。基於上述原因，一項嶄新自助治療方法定名為『閱讀療法』(bibliotherapy) ，近期在抑鬱或精神症失常 (或稱 思覺失調) 患者的家庭進行研究，展示了一些臨床實據。『閱讀療法』是一項利用書籍，自我實踐，並以精神科註冊護士引導的閱讀和解決問題培訓誴合而成的自助式干預方法。 這項擬定的隨機對照實驗將測試基於自助問題解決方式的『閱讀療法』（PSBBP）對精神分裂症譜系障礙患者的中國籍家庭照顧者的有效性。我們將會採用一個重複測量、三組對比的設計，評估和比較兩個治療組 (PSBBP 和心理教育課程) 和日常門診和家庭支持服務 (附有自助手冊的對照組) 的治療成果。以隨機抽樣形式挑選129位在門診部的精神分裂症譜系障礙患者的家庭照顧者接受其中一項干預，其後進行十二個月的跟進。主要評量結果包括照顧者的負擔、照顧者經驗、及應對壓力和解決社交性問題的能力。次要研究結果包括患者的精神狀態、日常功能、自覺表達情感、及住院率。參加者將會在招募階段及干預後一周、六個月和十二個月進行評估。再者在十二個月的跟進期，採用Kaplan-Meier生存分析，分析治療及對照組再次住院的相對風險。這項硏究假定為接受 PSBBP 的參加者相比起心理教育干預和對照兩組，在十二個月的跟進期內為止，將會在照顧者的負擔、照顧經驗、及應對壓力和解決問題的能力等方面有更顯著的改善。 經過干預後第一輪評估 (干預後一周內)，我們會對兩個治療組之中挑選二十位照顧者(每組十位) 進行焦點小組訪談。就著他們的分享資料進行內容性的數據分析，以識別他們對干預過程感受到的效益、限制和遭遇的困難，以及兩個干預方法治療性的成分。藉着『閱讀療法』(PSBBP) 研究中發現的正面成果，這干預方法將可採用於香港社區精神衛生服務，更可在亞洲其他國家進行複製研究，好讓照顧患有精神分裂症譜系障礙患者的家庭護理得到更大的改善。 |
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| Realisation of objectives: | The above two study objectives were fully fulfilled. The study has tested and supported the two hypotheses that, comparing with those in psycho-education and routine care, the problem-solving-based bibliotherapy programme (PSBBP) for families in schizophrenia indicated significantly greater reduction of caregivers’ perceived burden and improvement in caregiving experiences at 1-week, 6-month and 12-month follow-ups; and greater improvements in patients’ mental state, psychosocial functioning and re-hospitalization rate at the 6-month and 12-month follow-ups. Apart from the very positive quantitative outcomes found, the caregivers’ feedbacks in this study also suggested some improvements: (1) having the manual in electronic format (pdf/online) for easy access and convenient to read; (2) weekly self-record for reading progress and difficulties in problem-solving activities; (3) having facilitated group sessions (and telephone calls for reminders) to guide/motivate problem-solving activities. | ||||||||||||
| Summary of objectives addressed: |
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| Research Outcome | |||||||||||||
| Major findings and research outcome: | One hundred and forty of 460 eligible patients were randomly selected and contacted by the first author; 129 patients agreed to participate (response rate=92%). One hundred and twenty families (93%) completed the intervention and follow-up; one family in the PSBBP and two from usual care group withdrew, and also two participants in PSBBP and psychoeducation group were lost to contact during interventions and thus not included in the final analysis. While two caregivers discontinued their PSBBP participation, 38 (88%) completed ≥4 modules and 2 review sessions (>80% of PSBBP). Reasons for withdrawal/discontinuing from the PSBBP/study were: insufficient time to attend (n=2), patient’s mental state worsened (n=1), and lack of interest in participation (n=2). Qualitative feedbacks on the PSBBP were very positive (i.e., mainly helpful to their caregiving). Results of the MANOVA indicated a statistically significant difference between groups on the combined outcome variables, F(6,117)=6.34, p=0.001 (Wilks’ Lambda=0.86; a large effect with partial Eta squared=0.27). There was statistically significant interactive (Group x Time) treatment effects for the PSBBP (with large effect sizes), with significantly greater improvements in caregivers’ Caregiving Experience [F(1,116)=7.01, p=0.001, partial eta-squared=0.25] and its subscale scores [Positive experiences: F(1,116)=5.79, p=0.005; Negative experiences: F(1,116)=7.21, p=0.001] and family burden [F(1,117)=6.40, p=0.001, partial eta-squared=0.20]. The PSBBP group also had significant greater improvements in patients’ functioning [F(1,117)=6.04, p=0.005, partial eta-squared=0.20], mental state/symptom seveirty [F(1,117)=6.08, p=0.003, partial eta-squared=0.20], and length of re-hospitalizations [F(1,116)= 5.92, p=0.004, partial eta-squared=0.17]. The Helmert’s contrasts tests results indicated thatthe PSBBP had statistically greater significant improvements than the usual care (control) group on the changes in caregiving experience (both p=0.01), family burden (p=0.01 and 0.005), patient functioning (p=0.008 and 0.005), symptom severity (p=0.01 and 0.003), and length of re-hospitalisations (p=0.01 and 0.006) at 6-month and 12-month follow-ups. There were also statistically significant differences between the PSBBP and psycho-education group on the changes in family burden, patient functioning and symptom severity at 6- and 12-month follow-ups. However, there were no significant differences in the dosages of anti-psychotics (p=0.1), service use (p=0.15), medication adherence rates (p=0.17), and study sites (p=0.28) across measurements between-groups. Although no significant difference found between PSBBP and psycho-education group, the PSBBP group indicated greater reduction in the percentages of patients being re-hospitalised at the post-tests than usual care group [42.2% and 44.0% (pre-test), 33.0% and 43.4% (1-week post-intervention), 30.3% and 44.1% (6-month), and 27.5% and 42.8% (12-month)]; and these reductions were significantly different between-group across time (Kruskal-Wallis test, p=0.03). | ||||||||||||
| Potential for further development of the research and the proposed course of action: |
Apart from the very positive quantitative outcomes found, the caregivers’ feedback in this study also suggested some improvements: (1) having the manual in electronic format (pdf/online) for easy access and convenient to read; (2) weekly self-record for reading progress and difficulties in problem-solving activities; (3) having facilitated group sessions (and telephone calls for reminders) to guide/motivate problem-solving activities. These suggestions are integrated into the latest version of PSBBP and thus we proposed another adequate-powered trial of this refined PSBBP with a diverse sample of family carers in recent-onset psychosis. Our research team has proposed another randomised controlled trial of the refined/modified online caregiving self-help manual to examine its early intervention effects on family caregivers of people with recent-onset psychosis in Hong Kong. We had submitted a proposal to Health and Medical Research Fund for such a controlled trial investigating its effects on wide varieties of family carers’ and patients’ outcomes over 12-month follow-up, compared with usual psychiatric outpatient care (or early intervention service) only. It has recently been recommended for being funded subject to clarifications and amendments within a month and thus we are waiting for the final decision for this funding. | ||||||||||||
| Layman's Summary of Completion Report: | This randomised controlled trial supported the effectiveness of the problem-solving based bibliotherapy program (PSBBP) for Chinese family caregivers in schizophrenia-spectrum disorders in Hong Kong. The results indicate that the PSBBP group reported significantly greater improvements in family burden and caregiving experience, and reductions in severity of psychotic symptoms and re-hospitalisations, than the conventional psycho-education and usual care group at a moderate long-term (12 months) follow-up, and is also a low-cost adjunct to usual psychiatric care. The study provides scientific evidence on the effectiveness of the problem-solving-based bibliotherapy for Chinese caregivers in schizophrenia, where self-help programs are relatively less common than Western countries. The PSBBP pilot-tested by the research team (Hong Kong/Australia) has been evaluated in this trial to confirm its long-term benefits to family burden, experiences and well-being in caregiving, and improving patients’ relapse and functioning. This self-help programme can be recommended to clinicians and managers to be integrated into the local, national and international community mental health services (i.e., the English and Chinese versions are ready for use). The findings shed light into the acceptability and clinical efficacy of self-help and problem-solving strategies for family caregivers in Chinese, Australian (with the original version), and Asian psychotic patient populations. | ||||||||||||
| Research Output | |||||||||||||
| Peer-reviewed journal publication(s) arising directly from this research project : (* denotes the corresponding author) |
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| Recognized international conference(s) in which paper(s) related to this research project was/were delivered : |
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| Other impact (e.g. award of patents or prizes, collaboration with other research institutions, technology transfer, etc.): |
Our research team has proposed another randomised controlled trial of the refined/modified 5-module caregiving self-help manual with problem-solving exercises/practices and 4-5 facilitator-supported group sessions, to examine its early intervention effects on family caregivers of people with recent-onset psychosis in Hong Kong. We submitted a proposal to the Health and Medical Research Fund for the controlled trial investigating the effects of an online manual of PSBBP on several family carers’ and patients’ outcomes over 12-month follow-up, compared with a family psycho-education group (validated and used by the research team recently) and usual psychiatric outpatient care (or early intervention service) only. It has recently been recommended for being funded subject to clarifications and amendments within a month and thus we are waiting for the final decision for this funding. We have discussed with our national and overseas research collaborators to adopt this self-help manual and test this implementation in their countries for cross-cultural application and future comparison of the findings and its usefulness internationally. With positive feedback received, this intervention and its proposal for implementation and evaluation will be finalised in early 2018 (probably in China and/or Thailand). | ||||||||||||
| SCREEN ID: SCRRM00542 |