Schizophrenia Clinical Trial
— PSBBPOfficial title:
A Randomized Controlled Trial of Problem-solving Based Bibliotherapy Program for Family Caregivers of People With Psychotic Disorders
NCT number | NCT02391649 |
Other study ID # | 15401114 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 1, 2014 |
Est. completion date | August 30, 2020 |
Verified date | September 2020 |
Source | Chinese University of Hong Kong |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 422 |
Est. completion date | August 30, 2020 |
Est. primary completion date | August 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
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 one psychotic disorder in the past 5 years (for Phase 1, patients with recent-onset [12 months] or first-episode psychosis will be recruited); - 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) Exclusion criteria of family caregivers include: - those received or are receiving another family intervention; - those are having cognitive impairment or learning disability; and/or - those 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. |
Country | Name | City | State |
---|---|---|---|
Hong Kong | Li Ka Shing Specialty OPD | Sha Tin | NT |
Hong Kong | TM Psy Centre | Tuen Mun | NT |
Lead Sponsor | Collaborator |
---|---|
Chinese University of Hong Kong | Castle Peak Hospital, Prince of Wales Hospital, Shatin, Hong Kong, University of Victoria |
Hong Kong,
Breitborde NJ, Moreno FA, Mai-Dixon N, Peterson R, Durst L, Bernstein B, Byreddy S, McFarlane WR. Multifamily group psychoeducation and cognitive remediation for first-episode psychosis: a randomized controlled trial. BMC Psychiatry. 2011 Jan 12;11:9. doi: 10.1186/1471-244X-11-9. — View Citation
Chien WT, Chan SW. Testing the psychometric properties of a Chinese version of the Level of Expressed Emotion scale. Res Nurs Health. 2009 Feb;32(1):59-70. doi: 10.1002/nur.20303. — View Citation
Chien WT, Lee IY. The schizophrenia care management program for family caregivers of Chinese patients with schizophrenia. Psychiatr Serv. 2010 Mar;61(3):317-20. doi: 10.1176/ps.2010.61.3.317. — View Citation
Chien WT, Leung SF, Yeung FK, Wong WK. Current approaches to treatments for schizophrenia spectrum disorders, part II: psychosocial interventions and patient-focused perspectives in psychiatric care. Neuropsychiatr Dis Treat. 2013;9:1463-81. doi: 10.2147/NDT.S49263. Epub 2013 Sep 25. Review. — View Citation
Chien WT, Yip AL, Liu JY, McMaster TW. The effectiveness of manual-guided, problem-solving-based self-learning programme for family caregivers of people with recent-onset psychosis: A randomised controlled trial with 6-month follow-up. Int J Nurs Stud. 20 — View Citation
McCann TV, Lubman DI, Cotton SM, Murphy B, Crisp K, Catania L, Marck C, Gleeson JF. A randomized controlled trial of bibliotherapy for carers of young people with first-episode psychosis. Schizophr Bull. 2013 Nov;39(6):1307-17. doi: 10.1093/schbul/sbs121. Epub 2012 Nov 20. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Perceived burden of care (Chinese version of the 25-item Family Burden Interview Schedule) | Caregivers' perceived burden of care will be measured by a Chinese version of the 25-item Family Burden Interview Schedule. | 6 months (for Phases 1 and 2) after completion of intervention | |
Primary | Perceived burden of care (Chinese version of the 25-item Family Burden Interview Schedule) | Caregivers' perceived burden of care will be measured by a Chinese version of the 25-item Family Burden Interview Schedule. | 12 months (for Phases 1 and 2) after completion of intervention | |
Primary | Perceived burden of care (Chinese version of the 25-item Family Burden Interview Schedule) | Caregivers' perceived burden of care will be measured by a Chinese version of the 25-item Family Burden Interview Schedule. | 24 months (for Phase 2 only) after completion of intervention | |
Primary | Coping style (42-item Revised Ways of Coping Checklist) | A Chinese version of Coping style of the caregivers style will be assessed using the 42-item Revised Ways of Coping Checklist. | 6 months (for Phases 1 and 2) after completion of intervention | |
Primary | Coping style (42-item Revised Ways of Coping Checklist) | A Chinese version of Coping style of the caregivers style will be assessed using the 42-item Revised Ways of Coping Checklist. | 12 months (for Phases 1 and 2) after completion of intervention | |
Primary | Coping style (42-item Revised Ways of Coping Checklist) | A Chinese version of Coping style of the caregivers style will be assessed using the 42-item Revised Ways of Coping Checklist. | 24 months (for Phase 2 only) after completion of intervention | |
Secondary | Experience of caregiving (Chinese version of Experience of Caregiving Inventory) | 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. | 24 months (Phase 2; 6 and 12 months for Phase 1) after completion of intervention | |
Secondary | Social Problem-Solving (Chinese version of Revised (Short) Social Problem-Solving Inventory) | The Chinese version of Revised (Short) Social Problem-Solving Inventory will be used to assess participants' problem solving. | 24 months (Phase 2; 6 and 12 months for Phase 1) after completion of intervention | |
Secondary | Mental state (Positive and Negative Syndrome Scale) | 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. | 24 months (Phase 2; 6 and 12 months for Phase 1) after completion of intervention | |
Secondary | Patient functioning (43-item Specific Level of Functioning Scale) | The 43-item Specific Level of Functioning Scale will be used to assess 3 functional domains for patients with schizophrenia spectrum disorders, including physical functioning/personal care (12 items), social functioning (14 items) and community living skills (17 items) on a 5-point Likert scale. | 24 months (Phase 2; 6 and 12 months for Phase 1) after completion of intervention | |
Secondary | Perceived expressed emotion (Level of Expressed Emotion scale; used in Phase 2 only) | 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'). | 24 months after completion of intervention | |
Secondary | Rate and length of re-hospitalizations | The data of patients' frequency and lengths (days) of psychiatric hospitalizations over the intervention period, 6 months, 12 months or 24 months follow-ups, will be recorded by the research assistant by reviewing the electronic patient records. | 24 months (Phase 1; 6 and 12 months for Phase 1) after completion of intervention |
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