Problem-solving-based Bibliotherapy Program for Family Caregivers
Condition: Schizophrenia; Psychotic Disorders
MeSH terms: Schizophrenia; Mental Disorders; Psychotic Disorders
Study type: Interventional

Summary: 
      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.
    

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.
    

Intervention name(s): Self-learning program; Psycho-education program (in Phase 2)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; 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'.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Repeated-measures, three-arm design (and in phase 1, two pilot 2-arm controlled trials with repeated-measures design; sample size 112 for the two pilot studies)
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: psychosis; self-learning program; problem-solving; family caregivers; randomized controlled trial