SchizophreniaPSBBPNCT02391649
Problem-solving-based Bibliotherapy Program for Family Caregivers
A study testing Self-learning program and Psycho-education program (in Phase 2) in people with Schizophrenia and Psychotic Disorders, run by Chinese University of Hong Kong at 2 sites in Hong Kong.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia, Psychotic Disorders
- What is being tested?
- Self-learning program and Psycho-education program (in Phase 2)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 422 participants
- Where
- 2 sitesHong Kong
- Study dates
- 1 Mar 2014to 30 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Hong Kong2 sites
Li Ka Shing Specialty OPD
Shatin, NT
TM Psy Centre
Tuenmen, NT
About this study
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.
Read the detailed description
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.
- Conditions
- Schizophrenia, Psychotic Disorders
- Being tested
- Self-learning program, Psycho-education program (in Phase 2)
- Keywords
- psychosis, self-learning program, problem-solving, family caregivers, randomized controlled trial
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-learning programBehavioural
The PSBBP in this study consists of 5 modules (Module 1: Caregiver's well-being; Module 2:Getting the best out of support services; Module 3:Well-being of the person with schizophrenia; Module 4:Dealing with the [psychosocial] effects of the illness; and Module 5:Dealing with [physical and mental health] effects of the illness), helping each caregiver from developing a positive attitude to caregiving, identifying caring related problems and obstacles, predicting positive and negative implications of each alternative, to trying out the solution and monitor if it worked.
Psycho-education program (in Phase 2)Behavioural
The program consists of 12 two-hour sessions held weekly/biweekly completed in 5 months, with 4 main components, including 'introduction and goal setting'; 'an education workshop on mental illness, treatment and community services'; 'group exercises/rehearsals and discussion on symptom management, coping and self-care'; and 'review and future plan'.
| Study group | Role | What they receive |
|---|---|---|
| Self-learning program | Experimental | The participants in the Problem-solving Based Self-learning Program will complete the self-help and problem-solving manual developed by the research team for caregivers of people with psychotic disorders over 20 weeks. In addition to the orientation, understanding about psychosis and its care and final review sessions (4 sessions in 3 weeks) facilitated by the research nurse, the caregivers will work independently through the modules over 15-17 weeks. Receives: Behavioral: Self-learning program |
| Psycho-education (in Phase 2) | Active comparator | 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 and McFarlane and his colleagues' psychoeducation programs for psychosis. The program consists of 12 two-hour sessions held weekly/biweekly (similar to the self-learning program, completed in 5 months), with 4 main components, including 'introduction and goal setting'; 'an education workshop on mental illness, treatment and community services'; 'group exercises/rehearsals and discussion on symptom management, coping and self-care'; and ''review and future plan'. Receives: Behavioral: Psycho-education program (in Phase 2) |
| Routine community care | No intervention | Participants in the control group (and treatment groups) will receive routine psychiatric outpatient and family services. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months (for Phases 1 and 2) after completion of intervention
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.
Measured: 12 months (for Phases 1 and 2) after completion of intervention
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.
Measured: 24 months (for Phase 2 only) after completion of intervention
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.
Measured: 6 months (for Phases 1 and 2) after completion of intervention
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.
Measured: 12 months (for Phases 1 and 2) after completion of intervention
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.
Measured: 24 months (for Phase 2 only) after completion of intervention
Secondary outcomes (6)
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.
Measured: 24 months (Phase 2; 6 and 12 months for Phase 1) after completion of intervention
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.
Measured: 24 months (Phase 2; 6 and 12 months for Phase 1) after completion of intervention
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.
Measured: 24 months (Phase 2; 6 and 12 months for Phase 1) after completion of intervention
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.
Measured: 24 months (Phase 2; 6 and 12 months for Phase 1) after completion of intervention
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').
Measured: 24 months after completion of intervention
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.
Measured: 24 months (Phase 1; 6 and 12 months for Phase 1) after completion of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2015 (estimated)
- Study start1 Mar 2014
- Primary completion31 Aug 2019
- Study completion30 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Repeated-measures, three-arm design (and in phase 1, two pilot 2-arm controlled trials with repeated-measures design; sample size 112 for the two pilot studies)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 422 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Castle Peak Hospital, Prince of Wales Hospital, Shatin, Hong Kong, University of Victoria
- Responsible party
- Principal investigator, Prof. Wai Tong CHIEN, Chinese University of Hong Kong
- Investigators
- Wai Tong CHIEN, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02391649
- Sponsor's protocol ID
- 15401114
- Acronym
- PSBBP
- Status last verified
- Sep 2020
- First submitted
- 12 Mar 2015
- Last updated
- 14 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 18800379McCann 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.
PubMed 23172001Chien 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.
PubMed 20194413Chien 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.
PubMed 24109184Breitborde 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.
PubMed 21226941Chien 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. 2016 Jul;59:141-55. doi: 10.1016/j.ijnurstu.2016.03.018. Epub 2016 Apr 6.
PubMed 27222459
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Problem-solving Based Bibliotherapy Program for Family Caregivers of People With Psychotic Disorders
- ClinicalTrials.gov ID
- NCT02391649
- Acronym / sponsor ID
- PSBBP / 15401114
- Conditions
- Schizophrenia, Psychotic Disorders
- Keywords
- psychosis, self-learning program, problem-solving, family caregivers, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 422 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Collaborators
- Castle Peak Hospital, Prince of Wales Hospital, Shatin, Hong Kong, University of Victoria
- Study start
- 1 Mar 2014 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 30 Aug 2020 (actual)
- First posted
- 18 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Repeated-measures, three-arm design (and in phase 1, two pilot 2-arm controlled trials with repeated-measures design; sample size 112 for the two pilot studies)
| Arm | Type | Receives |
|---|---|---|
| Self-learning program | Experimental | Behavioral: Self-learning programThe participants in the Problem-solving Based Self-learning Program will complete the self-help and problem-solving manual developed by the research team for caregivers of people with psychotic disorders over 20 weeks. In addition to the orientation, understanding about psychosis and its care and final review sessions (4 sessions in 3 weeks) facilitated by the research nurse, the caregivers will work independently through the modules over 15-17 weeks. |
| Psycho-education (in Phase 2) | Active comparator | Behavioral: Psycho-education program (in Phase 2)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 and McFarlane and his colleagues' psychoeducation programs for psychosis. The program consists of 12 two-hour sessions held weekly/biweekly (similar to the self-learning program, completed in 5 months), with 4 main components, including 'introduction and goal setting'; 'an education workshop on mental illness, treatment and community services'; 'group exercises/rehearsals and discussion on symptom management, coping and self-care'; and ''review and future plan'. |
| Routine community care | No intervention | –Participants in the control group (and treatment groups) will receive routine psychiatric outpatient and family services. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-learning programThe PSBBP in this study consists of 5 modules (Module 1: Caregiver's well-being; Module 2:Getting the best out of support services; Module 3:Well-being of the person with schizophrenia; Module 4:Dealing with the [psychosocial] effects of the illness; and Module 5:Dealing with [physical and mental health] effects of the illness), helping each caregiver from developing a positive attitude to caregiving, identifying caring related problems and obstacles, predicting positive and negative implications of each alternative, to trying out the solution and monitor if it worked. | Behavioural | Self-learning program |
| Psycho-education program (in Phase 2)The program consists of 12 two-hour sessions held weekly/biweekly completed in 5 months, with 4 main components, including 'introduction and goal setting'; 'an education workshop on mental illness, treatment and community services'; 'group exercises/rehearsals and discussion on symptom management, coping and self-care'; and 'review and future plan'. | Behavioural | Psycho-education (in Phase 2) |
Primary outcome
Perceived burden of care (Chinese version of the 25-item Family Burden Interview Schedule)
Time frame: 6 months (for Phases 1 and 2) after completion of intervention
Caregivers' perceived burden of care will be measured by a Chinese version of the 25-item Family Burden Interview Schedule.
Perceived burden of care (Chinese version of the 25-item Family Burden Interview Schedule)
Time frame: 12 months (for Phases 1 and 2) after completion of intervention
Caregivers' perceived burden of care will be measured by a Chinese version of the 25-item Family Burden Interview Schedule.
Perceived burden of care (Chinese version of the 25-item Family Burden Interview Schedule)
Time frame: 24 months (for Phase 2 only) after completion of intervention
Caregivers' perceived burden of care will be measured by a Chinese version of the 25-item Family Burden Interview Schedule.
Coping style (42-item Revised Ways of Coping Checklist)
Time frame: 6 months (for Phases 1 and 2) after completion of intervention
A Chinese version of Coping style of the caregivers style will be assessed using the 42-item Revised Ways of Coping Checklist.
Coping style (42-item Revised Ways of Coping Checklist)
Time frame: 12 months (for Phases 1 and 2) after completion of intervention
A Chinese version of Coping style of the caregivers style will be assessed using the 42-item Revised Ways of Coping Checklist.
Coping style (42-item Revised Ways of Coping Checklist)
Time frame: 24 months (for Phase 2 only) after completion of intervention
A Chinese version of Coping style of the caregivers style will be assessed using the 42-item Revised Ways of Coping Checklist.
6 secondary outcomes
Experience of caregiving (Chinese version of Experience of Caregiving Inventory)
Time frame: 24 months (Phase 2; 6 and 12 months for Phase 1) after completion of intervention
Social Problem-Solving (Chinese version of Revised (Short) Social Problem-Solving Inventory)
Time frame: 24 months (Phase 2; 6 and 12 months for Phase 1) after completion of intervention
Mental state (Positive and Negative Syndrome Scale)
Time frame: 24 months (Phase 2; 6 and 12 months for Phase 1) after completion of intervention
Patient functioning (43-item Specific Level of Functioning Scale)
Time frame: 24 months (Phase 2; 6 and 12 months for Phase 1) after completion of intervention
Perceived expressed emotion (Level of Expressed Emotion scale; used in Phase 2 only)
Time frame: 24 months after completion of intervention
Rate and length of re-hospitalizations
Time frame: 24 months (Phase 1; 6 and 12 months for Phase 1) after completion of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2020.
- Background: PubMed 18800379Chien 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.
- Background: PubMed 23172001McCann 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.
- Background: PubMed 20194413Chien 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.
- Background: PubMed 24109184Chien 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.
- Background: PubMed 21226941Breitborde 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.
- Results publication: PubMed 27222459Chien 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. 2016 Jul;59:141-55. doi: 10.1016/j.ijnurstu.2016.03.018. Epub 2016 Apr 6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wai Tong CHIEN principal investigator
The Hong Kong Polytechnic University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-learning program and Psycho-education program (in Phase 2) in people with Schizophrenia and Psychotic Disorders, run by Chinese University of Hong Kong at 2 sites in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived burden of care (Chinese version of the 25-item Family Burden Interview Schedule) (time frame: 6 months (for Phases 1 and 2) after completion of intervention). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02391649, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2020.