Problem-solving-based Bibliotherapy Program for Family Caregivers (PSBBP)

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

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.

Study Overview

• Status: Completed
• Conditions: Psychotic Disorders; Schizophrenia
• Intervention / Treatment: Behavioral: Self-learning program; Behavioral: Psycho-education program (in Phase 2)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 422
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • NT
    • Sha Tin, NT, Hong Kong
      • Li Ka Shing Specialty OPD
    • Tuen Mun, NT, Hong Kong
      • TM Psy Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria of the participants include those who:

• Hong Kong Chinese residents, aged 18-60;
• taking care of and living with a family member primarily diagnosed with one psychotic disorder in the past 5 years (for Phase 1, patients with recent-onset [12 months] or first-episode psychosis will be recruited);
• able to read and understand Cantonese/Mandarin; and
• perceived a moderate to high burden of care (measured by Family Burden Interview Schedule (>20 out of 50 scores)

Exclusion criteria of family caregivers include:

• those received or are receiving another family intervention;
• those are having cognitive impairment or learning disability; and/or
• those presented with a recent personal history of a serious mental illness or medical disease that may adversely affect their ability to participate in the intervention.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Self-learning program; The participants in the Problem-solving Based Self-learning Program will complete the self-help and problem-solving manual developed by the research team for caregivers of people with psychotic disorders over 20 weeks. In addition to the orientation, understanding about psychosis and its care and final review sessions (4 sessions in 3 weeks) facilitated by the research nurse, the caregivers will work independently through the modules over 15-17 weeks.	Behavioral: Self-learning program; The PSBBP in this study consists of 5 modules (Module 1: Caregiver's well-being; Module 2:Getting the best out of support services; Module 3:Well-being of the person with schizophrenia; Module 4:Dealing with the [psychosocial] effects of the illness; and Module 5:Dealing with [physical and mental health] effects of the illness), helping each caregiver from developing a positive attitude to caregiving, identifying caring related problems and obstacles, predicting positive and negative implications of each alternative, to trying out the solution and monitor if it worked.
Active Comparator: Psycho-education (in Phase 2); Two trained advanced practice psychiatric nurses who are experienced in psychiatric rehabilitation and group programs will lead the psychoeducation group, which is guided by a validated treatment protocol based on the research team's and McFarlane and his colleagues' psychoeducation programs for psychosis. The program consists of 12 two-hour sessions held weekly/biweekly (similar to the self-learning program, completed in 5 months), with 4 main components, including 'introduction and goal setting'; 'an education workshop on mental illness, treatment and community services'; 'group exercises/rehearsals and discussion on symptom management, coping and self-care'; and ''review and future plan'.	Behavioral: Psycho-education program (in Phase 2); The program consists of 12 two-hour sessions held weekly/biweekly completed in 5 months, with 4 main components, including 'introduction and goal setting'; 'an education workshop on mental illness, treatment and community services'; 'group exercises/rehearsals and discussion on symptom management, coping and self-care'; and 'review and future plan'.
No Intervention: Routine community care; Participants in the control group (and treatment groups) will receive routine psychiatric outpatient and family services.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived burden of care (Chinese version of the 25-item Family Burden Interview Schedule)	Caregivers' perceived burden of care will be measured by a Chinese version of the 25-item Family Burden Interview Schedule.	6 months (for Phases 1 and 2) after completion of intervention
Perceived burden of care (Chinese version of the 25-item Family Burden Interview Schedule)	Caregivers' perceived burden of care will be measured by a Chinese version of the 25-item Family Burden Interview Schedule.	12 months (for Phases 1 and 2) after completion of intervention
Perceived burden of care (Chinese version of the 25-item Family Burden Interview Schedule)	Caregivers' perceived burden of care will be measured by a Chinese version of the 25-item Family Burden Interview Schedule.	24 months (for Phase 2 only) after completion of intervention
Coping style (42-item Revised Ways of Coping Checklist)	A Chinese version of Coping style of the caregivers style will be assessed using the 42-item Revised Ways of Coping Checklist.	6 months (for Phases 1 and 2) after completion of intervention
Coping style (42-item Revised Ways of Coping Checklist)	A Chinese version of Coping style of the caregivers style will be assessed using the 42-item Revised Ways of Coping Checklist.	12 months (for Phases 1 and 2) after completion of intervention
Coping style (42-item Revised Ways of Coping Checklist)	A Chinese version of Coping style of the caregivers style will be assessed using the 42-item Revised Ways of Coping Checklist.	24 months (for Phase 2 only) after completion of intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Experience of caregiving (Chinese version of Experience of Caregiving Inventory)	The Chinese version of Experience of Caregiving Inventory is a 66-item self-reporting scale that measures experiences of caregiving to a family member with mental illness based on the transactional model of stress-appraisal-coping.	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)	The Chinese version of Revised (Short) Social Problem-Solving Inventory will be used to assess participants' problem solving.	24 months (Phase 2; 6 and 12 months for Phase 1) after completion of intervention
Mental state (Positive and Negative Syndrome Scale)	Patients' mental state will be evaluated by the Positive and Negative Syndrome Scale, a 30-item inventory assessing the absence/severity of psychotic symptoms across positive symptoms, negative symptoms and general psycho-pathology symptoms.	24 months (Phase 2; 6 and 12 months for Phase 1) after completion of intervention
Patient functioning (43-item Specific Level of Functioning Scale)	The 43-item Specific Level of Functioning Scale will be used to assess 3 functional domains for patients with schizophrenia spectrum disorders, including physical functioning/personal care (12 items), social functioning (14 items) and community living skills (17 items) on a 5-point Likert 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)	Perceived expressed emotion by patients will be measured by Level of Expressed Emotion scale.The scale comprises 4 domains: intrusiveness, attitude toward illness, tolerance/expectancy, and emotional responses; each consists of 15 items on a 4-point Likert scale ('1-Not true' to '4-True').	24 months after completion of intervention
Rate and length of re-hospitalizations	The data of patients' frequency and lengths (days) of psychiatric hospitalizations over the intervention period, 6 months, 12 months or 24 months follow-ups, will be recorded by the research assistant by reviewing the electronic patient records.	24 months (Phase 1; 6 and 12 months for Phase 1) after completion of intervention

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Collaborators: University of Victoria; Prince of Wales Hospital, Shatin, Hong Kong; Castle Peak Hospital
• Investigators: Principal Investigator: Wai Tong CHIEN, The Hong Kong Polytechnic University

Publications and helpful links

General Publications

• Chien WT, Chan SW. Testing the psychometric properties of a Chinese version of the Level of Expressed Emotion scale. Res Nurs Health. 2009 Feb;32(1):59-70. doi: 10.1002/nur.20303.
• McCann TV, Lubman DI, Cotton SM, Murphy B, Crisp K, Catania L, Marck C, Gleeson JF. A randomized controlled trial of bibliotherapy for carers of young people with first-episode psychosis. Schizophr Bull. 2013 Nov;39(6):1307-17. doi: 10.1093/schbul/sbs121. Epub 2012 Nov 20.
• Chien WT, Lee IY. The schizophrenia care management program for family caregivers of Chinese patients with schizophrenia. Psychiatr Serv. 2010 Mar;61(3):317-20. doi: 10.1176/ps.2010.61.3.317.
• Chien WT, Leung SF, Yeung FK, Wong WK. Current approaches to treatments for schizophrenia spectrum disorders, part II: psychosocial interventions and patient-focused perspectives in psychiatric care. Neuropsychiatr Dis Treat. 2013;9:1463-81. doi: 10.2147/NDT.S49263. Epub 2013 Sep 25.
• Breitborde NJ, Moreno FA, Mai-Dixon N, Peterson R, Durst L, Bernstein B, Byreddy S, McFarlane WR. Multifamily group psychoeducation and cognitive remediation for first-episode psychosis: a randomized controlled trial. BMC Psychiatry. 2011 Jan 12;11:9. doi: 10.1186/1471-244X-11-9.
• Chien WT, Yip AL, Liu JY, McMaster TW. The effectiveness of manual-guided, problem-solving-based self-learning programme for family caregivers of people with recent-onset psychosis: A randomised controlled trial with 6-month follow-up. Int J Nurs Stud. 2016 Jul;59:141-55. doi: 10.1016/j.ijnurstu.2016.03.018. Epub 2016 Apr 6. Erratum In: Int J Nurs Stud. 2021 Jan;113:103794.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2014
• Primary Completion (Actual): August 31, 2019
• Study Completion (Actual): August 30, 2020

Study Registration Dates

• First Submitted: March 12, 2015
• First Submitted That Met QC Criteria: March 17, 2015
• First Posted (Estimate): March 18, 2015

Study Record Updates

• Last Update Posted (Actual): September 14, 2020
• Last Update Submitted That Met QC Criteria: September 10, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: randomized controlled trial; psychosis; family caregivers; problem-solving; self-learning program
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Psychotic Disorders; Mental Disorders
• Other Study ID Numbers: 15401114

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No