Clinical trial NCT02283437: A Problem-solving Based Bibliotherapy Program for Family Caregivers in Schizophrenia
Official title: A Randomized Controlled Trial of Problem-solving Based Bibliotherapy Program for Family Caregivers of People With Schizophrenia Spectrum Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia Spectrum Disorders
Family Caregivers
Keywords: Bibliotherapy
Problem-solving
Randomized Controlled Trial
Schizophrenia Spectrum Disorders
Family Caregivers
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Integrated Community Care and Family Support Centres
First posted: 2014-11-05
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Repeated-measures, three-arm design
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This proposed randomized controlled trial will test the effectiveness of a problem-solving based bibliotherapy program (PSBPF) 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 (PSBPF and behavioral management group) and routine outpatient service (control group) for 150 randomly selected family caregivers of outpatients with schizophrenia-spectrum disorders over a 18-month follow-up.

Detailed description: 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 or emotional involvement, which in turn may contribute to a greater risk of patient relapse and non-recovery. While family psycho-education (behavioral management) 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 (PSBPF) 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 (PSBPF and behavioral management and educational group) and routine outpatient service and family support(control group) for 150 randomly selected family caregivers of outpatients with schizophrenia-spectrum disorders over a 18-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 18 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 18-month follow-up. It is hypothesized that the PSBPF participants will produce significantly better improvements in caregivers' perceived burden, caregiving experience and coping and problem-solving skills than those in behavioral management/education and control groups over 18-month follow-up.

Focus group interviews will be conducted after the first post-test with 30 caregivers (15 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 PSBPF, 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.

Study Objectives:

This controlled trial tests the effects of the PSBPF on family caregivers' and patients' outcomes over a 18-month follow-up, when compared with those in a behavioral management and education group or routine family services for outpatients. Primary outcomes include caregivers' burden of care, coping and problem-solving skills. It will test two hypotheses that, comparing with those in behavioral management and education/routine care, the PSBPF will indicate significantly:

* greater reduction of caregivers' perceived burden and improvements in coping and social problem-solving skills and caregiving experiences at 1-week, 6-month and/or 18-month follow-ups; and
* greater improvements in patients' mental state, psychosocial functioning, perceived expressed emotion, and re-hospitalization rate at the three follow-ups.

Eligibility criteria: Inclusion Criteria:

* Hong Kong Chinese residents, aged 18-64;
* Taking care of a family member primarily diagnosed as schizophrenia spectrum disorders, including schizophrenia, schizophreniform and schizoaffective disorders, as stated in the criteria of the Diagnostic and Statistical Manual (DSM-IV Text-Revised edition) in the past 3 years;
* 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 for case selection).

Exclusion Criteria:

* Caregivers have received or are receiving another family intervention; or
* Presented with a recent personal history of a serious mental illness/medical disease and/or learning difficulties.

Primary outcomes:
measure: Perceived Burden of Care
timeFrame: 18 months after completion of intervention
measure: Coping Style
timeFrame: 18 months follow-up
measure: Social Problem-Solving Inventory
timeFrame: 18 months follow-up
Secondary outcomes:
measure: Experience of Caregiving
timeFrame: 18 months follow-up
measure: Mental State
timeFrame: 18 months follow-up
measure: Patient Functioning
timeFrame: 18 months follow-up
measure: Perceived Expressed Emotion
timeFrame: 18 months follow-up
measure: Rate & Length of Rehospitalizations
timeFrame: 18 months follow-up
Other outcomes:
Locations:
city: Mongkok
country: Hong Kong
facility: KH OPD
state: Kowloon
city: Sha Tin
country: Hong Kong
facility: Li Ka Shing Specialty OPD
state: NT
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Wai Tong Chien, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: McCann TV, Lubman DI, Clark E. First-time primary caregivers' experience of caring for young adults with first-episode psychosis. Schizophr Bull. 2011 Mar;37(2):381-8. doi: 10.1093/schbul/sbp085. Epub 2009 Aug 13.
citation: 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.