SchizophreniaPhase 2MSGNCT00940394
Effectiveness of Family Group Interventions for People With Schizophrenia
A Phase 2 study testing mutual support group and psychoeducation group in people with Schizophrenia, run by The Hong Kong Polytechnic University at 2 sites in Hong Kong.
Trial summary
The mutual support group intervention would significantly improve the families' burden of care, functioning and social support, reduce the patients' severity of symptoms and re-hospitalizations, and reduce the demands for utilization of family services, when compared with the standard care group. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- mutual support group and psychoeducation group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 2 sitesHong Kong
- Study dates
- Jan 2007to Dec 2011
- Phase
- Phase 2
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- family caregivers lived with and cared for one family member diagnosed with schizophrenia according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV; American Psychiatric Association, 1994)
- family caregivers were at least 18 years of age and could understand and read the Chinese (Mandarin) language; and
- family caregivers were free from any mental illness themselves.
Who cannot join
- the patients with schizophrenia suffered no co-morbidity due to other mental illness during recruitment to the study
- family caregivers cared for more than one family member with mental or chronic physical illness; and/or
- family caregivers had been the primary carers for less than three months
Trial locations and contacts
2 sites in 1 country.
Hong Kong2 sites
Li Ka Shing Specialty OPD
Shatin, NT
AHNH Psychiatric OPD
Taipo, NT
About this study
Official title: Evaluation of the Effects of Mutual Support and Psycho-educational Group Interventions for Family Caregivers of People With Schizophrenia
The mutual support group intervention would significantly improve the families' burden of care, functioning and social support, reduce the patients' severity of symptoms and re-hospitalizations, and reduce the demands for utilization of family services, when compared with the standard care group.
Read the detailed description
Family interventions in schizophrenia have shown positive effects on patients but little attention has been paid to their effects on family members, particularly those in non-Western countries. This multi-site randomized controlled trial evaluated the effectiveness of a bi-weekly, 12-session, family-led mutual support group for Chinese caregivers of schizophrenia sufferers over 36 months, compared with a family psychoeducation group program and standard psychiatric care. It was conducted with 114 families of outpatients with schizophrenia in Hong Kong of whom 38 were assigned randomly to a mutual support group, a psychoeducation group, or standard care. Families' psychosocial health status and patients' symptom severity and length of re-hospitalizations at recruitment, one-month, 18-month, and 36-month post-intervention were compared between groups.
- Conditions
- Schizophrenia
- Being tested
- mutual support group, psychoeducation group, Standard care
- Keywords
- mutual support group, psychoeducation group, family caregivers, schizophrenia
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mutual support groupBehavioural
Also called FMSG
bi-weekly, 12-session, family-led mutual support group
psychoeducation groupBehavioural
Also called FPGP
bi-weekly, 12-session, family psychoeducation group
Standard careOther
Also called Usual psychiatric care
Routine mental health care services provided by the outpatient clinic and related agencies for families of people with schizophrenia
| Study group | Role | What they receive |
|---|---|---|
| standard care | Other | Families receive routine community and family mental health care services Receives: Other: Standard care |
| mutual support group | Experimental | bi-weekly, 12-session, family-led mutual support group Receives: Behavioral: mutual support group |
| psychoeducation group | Active comparator | bi-weekly, 12-session, family psychoeducation group program Receives: Behavioral: psychoeducation group |
What is being measured
The primary outcome is the main question the study is designed to answer.
length of re-hospitalizations
Measured: at recruitment, six-month, 18-month and 36-month post-intervention
Secondary outcomes (2)
families' perceived social support
Measured: at recruitment, six-month, 18-month and 36-month post-intervention
patients' symptom severity
Measured: at recruitment, six-month, 18-month and 36-month post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2009 (estimated)
- Study startJan 2007
- Primary completionSep 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe 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 2
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chien Wai-Tong, The Hong Kong Polytechnic University
- Investigators
- Chien Wai-Tong, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00940394
- Sponsor's protocol ID
- 216020
- Acronym
- MSG
- Status last verified
- Aug 2014
- First submitted
- 15 Jul 2009
- Last updated
- 21 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chien WT, Thompson DR, Norman I. Evaluation of a peer-led mutual support group for Chinese families of people with schizophrenia. Am J Community Psychol. 2008 Sep;42(1-2):122-34. doi: 10.1007/s10464-008-9178-8.
PubMed 18584319Chien WT, Thompson DR. An RCT with three-year follow-up of peer support groups for Chinese families of persons with schizophrenia. Psychiatr Serv. 2013 Oct;64(10):997-1005. doi: 10.1176/appi.ps.201200243.
PubMed 23820670Chien WT, Chan SW. The effectiveness of mutual support group intervention for Chinese families of people with schizophrenia: a randomised controlled trial with 24-month follow-up. Int J Nurs Stud. 2013 Oct;50(10):1326-40. doi: 10.1016/j.ijnurstu.2013.01.004. Epub 2013 Feb 19.
PubMed 23433723Chien WT, Bressington D, Chan SWC. A Randomized Controlled Trial on Mutual Support Group Intervention for Families of People With Recent-Onset Psychosis: A Four-Year Follow-Up. Front Psychiatry. 2018 Dec 18;9:710. doi: 10.3389/fpsyt.2018.00710. eCollection 2018.
PubMed 30618880
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Mutual Support and Psycho-educational Group Interventions for Family Caregivers of People With Schizophrenia
- ClinicalTrials.gov ID
- NCT00940394
- Acronym / sponsor ID
- MSG / 216020
- Conditions
- Schizophrenia
- Keywords
- mutual support group, psychoeducation group, family caregivers, schizophrenia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Sep 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 16 Jul 2009 (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.
The mutual support group intervention would significantly improve the families' burden of care, functioning and social support, reduce the patients' severity of symptoms and re-hospitalizations, and reduce the demands for utilization of family services, when compared with the standard care group.
Detailed description
Family interventions in schizophrenia have shown positive effects on patients but little attention has been paid to their effects on family members, particularly those in non-Western countries. This multi-site randomized controlled trial evaluated the effectiveness of a bi-weekly, 12-session, family-led mutual support group for Chinese caregivers of schizophrenia sufferers over 36 months, compared with a family psychoeducation group program and standard psychiatric care. It was conducted with 114 families of outpatients with schizophrenia in Hong Kong of whom 38 were assigned randomly to a mutual support group, a psychoeducation group, or standard care. Families' psychosocial health status and patients' symptom severity and length of re-hospitalizations at recruitment, one-month, 18-month, and 36-month post-intervention were compared between groups.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| standard care | Other | Other: Standard careFamilies receive routine community and family mental health care services |
| mutual support group | Experimental | Behavioral: mutual support groupbi-weekly, 12-session, family-led mutual support group |
| psychoeducation group | Active comparator | Behavioral: psychoeducation groupbi-weekly, 12-session, family psychoeducation group program |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- family caregivers lived with and cared for one family member diagnosed with schizophrenia according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV; American Psychiatric Association, 1994)
- family caregivers were at least 18 years of age and could understand and read the Chinese (Mandarin) language; and
- family caregivers were free from any mental illness themselves.
Key exclusion criteria (3 listed)
- the patients with schizophrenia suffered no co-morbidity due to other mental illness during recruitment to the study
- family caregivers cared for more than one family member with mental or chronic physical illness; and/or
- family caregivers had been the primary carers for less than three months
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 |
|---|---|---|
| mutual support groupAlso: FMSGbi-weekly, 12-session, family-led mutual support group | Behavioural | mutual support group |
| psychoeducation groupAlso: FPGPbi-weekly, 12-session, family psychoeducation group | Behavioural | psychoeducation group |
| Standard careAlso: Usual psychiatric careRoutine mental health care services provided by the outpatient clinic and related agencies for families of people with schizophrenia | Other | standard care |
Primary outcome
length of re-hospitalizations
Time frame: at recruitment, six-month, 18-month and 36-month post-intervention
2 secondary outcomes
families' perceived social support
Time frame: at recruitment, six-month, 18-month and 36-month post-intervention
patients' symptom severity
Time frame: at recruitment, six-month, 18-month and 36-month post-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 21 Aug 2014.
- Results publication: PubMed 18584319Chien WT, Thompson DR, Norman I. Evaluation of a peer-led mutual support group for Chinese families of people with schizophrenia. Am J Community Psychol. 2008 Sep;42(1-2):122-34. doi: 10.1007/s10464-008-9178-8.
- Results publication: PubMed 23820670Chien WT, Thompson DR. An RCT with three-year follow-up of peer support groups for Chinese families of persons with schizophrenia. Psychiatr Serv. 2013 Oct;64(10):997-1005. doi: 10.1176/appi.ps.201200243.
- Results publication: PubMed 23433723Chien WT, Chan SW. The effectiveness of mutual support group intervention for Chinese families of people with schizophrenia: a randomised controlled trial with 24-month follow-up. Int J Nurs Stud. 2013 Oct;50(10):1326-40. doi: 10.1016/j.ijnurstu.2013.01.004. Epub 2013 Feb 19.
- Derived from this study: PubMed 30618880Chien WT, Bressington D, Chan SWC. A Randomized Controlled Trial on Mutual Support Group Intervention for Families of People With Recent-Onset Psychosis: A Four-Year Follow-Up. Front Psychiatry. 2018 Dec 18;9:710. doi: 10.3389/fpsyt.2018.00710. eCollection 2018.
- Effectiveness of Psychoeducation and Mutual Support Group Program for Family Caregivers of Chinese People with SchizophreniaLink provided by the sponsor.
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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.
Chien Wai-Tong, PhD 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 Phase 2 study testing mutual support group and psychoeducation group in people with Schizophrenia, run by The Hong Kong Polytechnic University 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 3 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 21 Aug 2014. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
length of re-hospitalizations (time frame: at recruitment, six-month, 18-month and 36-month post-intervention). 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 NCT00940394, which also lists 4 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 21 Aug 2014.