A Problem-solving Based Bibliotherapy Program for Family Caregivers in Schizophrenia (PSBBP)
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|ClinicalTrials.gov Identifier: NCT02283437|
Recruitment Status : Recruiting
First Posted : November 5, 2014
Last Update Posted : February 22, 2018
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia Spectrum Disorders Family Caregivers||Behavioral: Problem-solving Based Bibliotherapy Program Behavioral: Psychoeducation Group Program||Not Applicable|
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. Kaplan-Meier survival analysis will be used to analyze the relative risks of re-hospitalizations amongst the treatment and control groups over 12-month follow-up. 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. With significant positive outcomes found in the PSBBP, 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.
This controlled trial tests the effects of the PSBBP on family caregivers' and patients' outcomes over a 12-month follow-up, when compared with those in a psycho-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 psycho-education/routine care, the PSBBP 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 12-month follow-ups; and
- greater improvements in patients' mental state, psychosocial functioning, perceived expressed emotion, and re-hospitalization rate at the three follow-ups.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||140 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Repeated-measures, three-arm design|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||Outcome assessors are blind to the group assignment and intervention received by the participants|
|Primary Purpose:||Health Services Research|
|Official Title:||A Randomized Controlled Trial of Problem-solving Based Bibliotherapy Program for Family Caregivers of People With Schizophrenia Spectrum Disorders|
|Actual Study Start Date :||January 1, 2017|
|Estimated Primary Completion Date :||June 30, 2018|
|Estimated Study Completion Date :||September 30, 2018|
Experimental: Problem-solving Based Bibliotherapy
The Problem-solving Based Bibliotherapy Program 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).
Behavioral: Problem-solving Based Bibliotherapy Program
The PSBBP will complete the bibliotherapy (self-help) and problem-solving manual developed by the research team for caregivers of people with schizophrenia spectrum disorders.
Other Name: PSBBP
Active Comparator: Psychoeducation Group Program
The psychoeducation group program will be guided by a validated treatment protocol based on the research team's (Chien and Wong, 2007) and McFarlane et al.'s (2003) psychoeducation programs for schizophrenia.
Behavioral: Psychoeducation Group Program
Two trained advanced practice psychiatric nurses who are experienced in psychiatric rehabilitation and group programs will lead the psychoeducation 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) psychoeducation programs for schizophrenia.
No Intervention: Routine Outpatient Service
Participants in the control group (and 2 treatment groups) will receive routine psychiatric outpatient and family services.
- Perceived Burden of Care [ Time Frame: 12 months after completion of intervention ]Caregivers' perceived burden of care will be measured by a Chinese version of the 25-item Family Burden Interview Schedule. It assesses the caring burden perceived by family members in taking care of the patient at home. It is comprised of six categories (2-6 items per category), including familial finance, routine, leisure activities, interactions, and physical and mental health. Total scores range from 0-50; a higher score will indicate a greater caring burden. The Chinese version of the scale indicated satisfactory internal consistency (Cronbach's alpha= 0.87) and high inter-rater reliability (Pearson's r= 0.75-0.99) in families of schizophrenia sufferers in Hong Kong.
- Coping Style [ Time Frame: 12 months follow-up ]A Chinese version of Coping style of the caregivers style will be assessed using the 42-item Revised Ways of Coping Checklist. It composes of a problem-focused coping(15 items) and three emotion-focused coping scales, including 'self-blame' (3 items), 'wishful thinking'(8 items) and 'avoidance'(10 items), and a subscale 'seeking social support'(6 items). Items are scored on a 5-point Likert scale, from '0-never' to '4-all the time', higher scores indicating greater uses of those coping strategies. It has demonstrated satisfactory internal consistency (Cronbach's alpha= 0.62-0.85) in students.
- Social Problem-Solving Inventory [ Time Frame: 12 months follow-up ]The Chinese version of Revised (Short) Social Problem-Solving Inventory. It contains 25 items, assessing 2 domains of social problem-solving, including problem-solving style(3 subscales- rational problem solving, impulsive/careless style and avoidance style), and problem-solving orientation (2 subscales- positive and negative problem orientation). It has demonstrated satisfactory internal consistency (Cronbach's alpha= 0.68-0.81) and concurrent validity with a few coping scales in Hong Kong adolescents.[
- Experience of Caregiving [ Time Frame: 12 months follow-up ]The Chinese version of Experience of Caregiving Inventory is a 66-item self-reporting scale that measures experiences of caregiving to a family member with mental illness based on the Transactional model of stress-appraisal-coping. It consists of 10 subscales measuring negative (e.g., difficult behaviors, stigma and problems with services) and positive aspects (positive personal experience and aspects of relationship) of caregiving, being rated on a 5-point Likert scale ('0-never' to '4-nearly always'). It indicates satisfactory content validity and internal consistency (Cronbach's alpha= 0.60-0.85); higher scores on negative/positive (reverse-coded) subscale indicate a more negative appraisals.
- Mental State [ Time Frame: 12 months follow-up ]Patients' mental state will be evaluated by the Positive and Negative Syndrome Scale, a 30-item inventory assessing the absence/severity of psychotic symptoms across positive symptoms, negative symptoms and general psycho-pathology symptoms. Each item is scored on a scale, ranging from '1- absent' to '7- extreme', and the scale has demonstrated good inter-rater reliability (Intra-class correlation= 0.88) and good internal consistency (Cronbach's alpha= 0.87-0.93), and concurrent and predictive validity.
- Patient Functioning [ Time Frame: 12 months follow-up ]The 43-item Specific Level of Functioning Scale will be used to assess 3 functional domains for patients with schizophrenia, including physical functioning/personal care (12 items), social functioning (14 items) and community living skills (17 items) on a 5-point Likert scale. The Chinese version was validated among patients with schizophrenia in Hong Kong, indicating satisfactory content validity, test-retest reliability (Pearson's r=0.76) and internal consistency (Cronbach's alpha= 0.88-0.96).
- Perceived Expressed Emotion [ Time Frame: 12 months follow-up ]Perceived expressed emotion by patients will be measured by Level of Expressed Emotion scale. The scale comprises 4 domains: intrusiveness, attitude toward illness, tolerance/expectancy, and emotional responses; each consists of 15 items on a 4-point Likert scale ('1-Not true' to '4-True'). The Chinese version has indicated satisfactory internal consistency (Cronbach's alpha= 0.80-0.90) and test-retest reliability (r= 0.87-0.93)
- Rate & Length of Rehospitalizations [ Time Frame: 12 months follow-up ]The data of patients' frequency and lengths (days) of psychiatric hospitalizations over the intervention period, and 12-month follow-ups, will be recorded by the research assistant by reviewing the electronic patient record (ePR) at outpatient clinics.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02283437
|Contact: Wai Tong Chien, PhD||852-2766 firstname.lastname@example.org|
|Contact: Ada Tse, MSc||852-2766 email@example.com|
|KH; LKS Specialty OPD||Recruiting|
|Shatin And Mongkok, NT/Kln, Hong Kong|
|Contact: Chan SWC, PhD 852-2609 6222 firstname.lastname@example.org|
|Principal Investigator: Chien WT, PhD|
|Li Ka Shing Specialty OPD||Active, not recruiting|
|Sha Tin, NT, Hong Kong|
|Principal Investigator:||Wai Tong Chien, PhD||The Hong Kong Polytechnic University|