A Problem-solving Based Bibliotherapy Program for Family Caregivers in Schizophrenia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-01

Study Completion Date

2020-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Schizophrenia Spectrum Disorders Family Caregivers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Repeated-measures, three-arm design

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Outcome assessors are blind to the group assignment and intervention received by the participants

Study Groups

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Problem-solving Based Bibliotherapy

The Problem-solving Based Bibliotherapy Program (PSBPF) using a self-help manual based on problem-solving therapy defined by D'Zurilla and Nezu (2007) to be 'a self-directed cognitive-behavioral process by which a person attempts to identify/discover effective/adaptive solutions for specific problems encountered in everyday living' (p.11).

Group Type EXPERIMENTAL

Problem-solving Based Bibliotherapy Program

Intervention Type BEHAVIORAL

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.

Behavioral Management and Education Program

The Behavioral Management and Education group program will be guided by a validated treatment protocol based on the research team's (Chien and Wong, 2007) psycho-education and McFarlane et al.'s (2003) family behavioral management programs for schizophrenia.

Group Type ACTIVE_COMPARATOR

Behavioral Management and Education Program

Intervention Type BEHAVIORAL

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.

Routine Outpatient Service

Participants in the control group (and 2 treatment groups) will receive routine psychiatric outpatient and family services.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Problem-solving Based Bibliotherapy Program

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.

Intervention Type BEHAVIORAL

Behavioral Management and Education Program

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.

Intervention Type BEHAVIORAL

Other Intervention Names

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PSBPF

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No