Schizophrenia Clinical Trial
Official title:
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.
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.
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