A Problem-solving Based Bibliotherapy Program for Family Caregivers in Schizophrenia
Condition: Schizophrenia Spectrum Disorders; Family Caregivers
MeSH terms: Schizophrenia
Study type: Interventional

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.
    

Intervention name(s): Problem-solving Based Bibliotherapy Program; Behavioral Management and Education Program
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The PSBPF will complete the bibliotherapy (self-help) and problem-solving manual developed by the research team for caregivers of people with schizophrenia spectrum disorders.; Two trained advanced practice psychiatric nurses who are experienced in psychiatric rehabilitation and group programs will lead the behavioral management and education group, which is guided by a validated treatment protocol based on the research team's (Chien and Wong, 2007) and McFarlane et al.'s (2001) family management programs for schizophrenia.
Other intervention name(s): PSBPF
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Repeated-measures, three-arm design
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Bibliotherapy; Problem-solving; Randomized Controlled Trial; Schizophrenia Spectrum Disorders; Family Caregivers