Patient case: 86-year-old female with melanoma; genetic feature: high tumor mutational burden

Clinical trial: Problem-solving-based Bibliotherapy Program for Family Caregivers

Summary: 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 (control group) for 129 randomly selected family caregivers of outpatients with schizophrenia-spectrum disorders over a 12-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 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 (control group) 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. 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.

Eligibility: 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 schizophrenia spectrum disorders 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)
  Family caregivers will be excluded if they have:
  -  received or are receiving another family intervention; or
  -  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.

Relevance to patient case: not relevant