SchizophreniaMBPPNCT01667601
Mindfulness-based Illness Management Program for Schizophrenia
A study testing Routine Care, Mindfulness-based program and Psychoeducation group in people with Schizophrenia, run by The Hong Kong Polytechnic University at 4 sites in 3 countries.
Trial summary
Only a few intervention studies have also focused on changing patients' negative thoughts and feelings towards the illness and their relationship to the suffering caused by those thoughts, which is evidenced to empower psychosocial functioning and control of distressing thoughts in severe depression and psychotic… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Routine Care, Mindfulness-based program and Psychoeducation group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 449 participants
- Where
- 4 sitesin 3 countries
- Study dates
- Aug 2010to Apr 2017
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- outpatients;
- aged 18+; and
- diagnosed as schizophrenia and other psychotic disorders (< or =5 years) according to the Diagnostic and Statistical Manual, 4th edition, as ascertained by the Structured Clinical Interview (SCID-I).
Who cannot join
- not able to understand the psycho-education content and Chinese;
- mentally unstable at recruitment; and
- with co-morbidity of other severe mental health problems such as depression and substance misuse.
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
About this study
Official title: The Effectiveness of a Mindfulness-based Illness Management Program for Chinese Patients With Schizophrenia: An Randomised Controlled Trial
Only a few intervention studies have also focused on changing patients' negative thoughts and feelings towards the illness and their relationship to the suffering caused by those thoughts, which is evidenced to empower psychosocial functioning and control of distressing thoughts in severe depression and psychotic disorders by using the Mindfulness-Based Stress Reduction program. This controlled trial is designed to test the effects of a mindfulness-based Illness management program (MBPP) for Chinese patients with schizophrenia on their symptom severity, illness insight and psychosocial functioning.
Read the detailed description
Objectives: This study is to test the effectiveness of a mindfulness-based illness management program for Chinese outpatients with schizophrenia over a 24-month follow-up. The program is an integrated, insight-inducing educational program that addresses patients' awareness and knowledge of schizophrenia and skills of illness management.
Methods: A two-phase, single-blind, multi-site randomized controlled trial will be conducted with 449 Chinese patients with schizophrenia in Hong Kong, China and Taiwan. In the first phase, 107 participants will be randomly selected from the eligible patient lists of three outpatient clinics in Hong Kong only (i.e., 38 subjects from each clinic), and after baseline measurement, be assigned to either the mindfulness-based illness management program, conventional psycho-education group, or usual psychiatric care. For the second phase, the participants will be randomly selected from the eligible patient list in three study venues or countries (i.e., 114 subjects from each study site/ country) and after baseline measurement, be assigned similar to the first phase to one of the three study groups. The patients' mental and psychosocial functioning, insights into illness, and their re-hospitalization rates will be measured at recruitment and at one week, and 6, 12 and 24 months after completing the interventions.
Hypothesis: The patients in the mindfulness-based psycho-education program will report significantly greater improvements in their symptoms and re-hospitalization rates (primary outcomes) and other secondary outcomes (e.g., insight into illness and functioning) over the 24-month follow-up, when compared with those in psycho-education group or usual care.
Conclusions: The findings will provide evidence whether the mindfulness-based psycho-education program can better improve Chinese schizophrenia sufferers' psychosocial functioning and reduce their illness relapse.
- Conditions
- Schizophrenia
- Being tested
- Routine Care, Mindfulness-based program, Psychoeducation group
- Keywords
- mindfulness-based program, Psychoeducation, schizophrenia, Chinese, outpatients
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine CareOther
Also called Routine Psychiatric Care
Psychiatric outpatient care provided by the outpatient departments, e.g., medical consultation, brief education by psychiatric nurses and financial advices or referrals by social workers.
Mindfulness-based programBehavioural
Also called Mindfulness-based illness management program, Mindfulness-based care for schizophrenia program
The program was based on the psychoeducation programs by Chien et al and Lehman et al, as well as the 8-session Mindfulness-Based Stress Reduction Program by Kabat-Zinn(1990).
Psychoeducation groupBehavioural
Also called Conventional psychoeducation group, Psychoeducation group intervention
A 5-month patient psychoeducation group program (12 sessions) led by the research team will be provided.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-based program | Experimental | A structured, researcher-designed mindfulness-based psycho-education program (6 months), comprised of 12 bi-weekly, 2-hour group sessions (10-12 patients per group). The program was based on the psycho-education programs by Chien et al. (2010) and Lehman et al. (2004), as well as the 8-session Mindfulness-Based Stress Reduction Program by Kabat-Zinn (1990). Receives: Behavioral: Mindfulness-based program |
| Routine Care | Other | Routine psychiatric outpatient care, including medication, psychiatric consultation in outpatient clinic, brief education by psychiatric nurses, financial and social welfare advices by social workers, and individual counseling by clinical psychologist. Receives: Other: Routine Care; Behavioral: Mindfulness-based program; Behavioral: Psychoeducation group |
| Psychoeducation group | Active comparator | A psychoeducation group program (12 sessions, bi-weekly) based on Dr. Macpherson's Family Psychoeducation Program in 1996 and Chien and Bressington's one in 2014/15 will be used.
References:
Chien WT, Bressington D. A randomized controlled trial of a nurse-led structured psychosocial intervention program for people with first-onset mental illness in psychiatric outpatient clinics. Psychiatry Res 2015;229:277-86.
Macpherson R, Jerrom B, Hughes AA. controlled study of education about drug treatment in schizophrenia. Br J Psychiatry 1996;168:709-17. Receives: Behavioral: Psychoeducation group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rehospitalization rates
Average amount (number) and length of hospital stay of the patients over previous six months will be assessed at recruitment and one week, 6 months, 12 months and 24 months after the interventions completed.
Measured: from recruitment to 24-month follow-up
Positive and Negative Syndrome Scale
The Positive and Negative Syndrome Scale assesses the severity of psychotic symptoms on three subscales: positive symptoms (7 items), negative symptoms (7 items) and general psychopathology (16 items). will be assessed at recruitment and one week, 6 months, 12 months and 24 months after the interventions completed. Symptom remission rate over the follow-up periods are also assessed. Complete remission was defined as 4-month simultaneous ratings of all individual items in PANSS as score ≤3.
Measured: from recruitment to 24-month follow-up
Secondary outcomes (1)
insights to illness and treatment
Patients' insight and attitudes to illness and treatment will be measured with the Insight and Treatment Attitudes Questionnaire at recruitment and one week, 6 months, 12 months and 24 months after the interventions completed.
Measured: from recruitment to 24-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2012 (estimated)
- Study startAug 2010
- Primary completionJun 2016
- Study completionApr 2017
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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 449 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Authority, Hong Kong, Jilin Medical College, China, Taipei Medical University
- Responsible party
- Principal investigator, Wai-Tong Chien, The Hong Kong Polytechnic University
- Investigators
- Chien WT, PhD, Principal investigator, The HK Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01667601
- Sponsor's protocol ID
- HSEARS20121211001
- Acronym
- MBPP
- Status last verified
- Jul 2017
- First submitted
- 15 Aug 2012
- Last updated
- 18 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Chien WT, Lee IY. The mindfulness-based psychoeducation program for Chinese patients with schizophrenia. Psychiatr Serv. 2013 Apr 1;64(4):376-9. doi: 10.1176/appi.ps.002092012.
PubMed 23412024Chien WT, Thompson DR. Effects of a mindfulness-based psychoeducation programme for Chinese patients with schizophrenia: 2-year follow-up. Br J Psychiatry. 2014 Jul;205(1):52-9. doi: 10.1192/bjp.bp.113.134635. Epub 2014 May 8.
PubMed 24809397Lam, A.H.Y., & Chien, W.T. (2016). The effectiveness of mindfulness-based intervention for people with schizophrenia: A systematic review. Neuropsychiatry (London), 6(5), 208-222.
Chien WT, Bressington D, Yip A, Karatzias T. An international multi-site, randomized controlled trial of a mindfulness-based psychoeducation group programme for people with schizophrenia. Psychol Med. 2017 Sep;47(12):2081-2096. doi: 10.1017/S0033291717000526. Epub 2017 Apr 4.
PubMed 28374661
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of a Mindfulness-based Illness Management Program for Chinese Patients With Schizophrenia: An Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT01667601
- Acronym / sponsor ID
- MBPP / HSEARS20121211001
- Conditions
- Schizophrenia
- Keywords
- mindfulness-based program, Psychoeducation, schizophrenia, Chinese, outpatients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 449 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- Hospital Authority, Hong Kong, Jilin Medical College, China, Taipei Medical University
- Study start
- Aug 2010
- Primary completion
- Jun 2016 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 17 Aug 2012 (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.
Only a few intervention studies have also focused on changing patients' negative thoughts and feelings towards the illness and their relationship to the suffering caused by those thoughts, which is evidenced to empower psychosocial functioning and control of distressing thoughts in severe depression and psychotic disorders by using the Mindfulness-Based Stress Reduction program. This controlled trial is designed to test the effects of a mindfulness-based Illness management program (MBPP) for Chinese patients with schizophrenia on their symptom severity, illness insight and psychosocial functioning.
Detailed description
Objectives: This study is to test the effectiveness of a mindfulness-based illness management program for Chinese outpatients with schizophrenia over a 24-month follow-up. The program is an integrated, insight-inducing educational program that addresses patients' awareness and knowledge of schizophrenia and skills of illness management.
Methods: A two-phase, single-blind, multi-site randomized controlled trial will be conducted with 449 Chinese patients with schizophrenia in Hong Kong, China and Taiwan. In the first phase, 107 participants will be randomly selected from the eligible patient lists of three outpatient clinics in Hong Kong only (i.e., 38 subjects from each clinic), and after baseline measurement, be assigned to either the mindfulness-based illness management program, conventional psycho-education group, or usual psychiatric care. For the second phase, the participants will be randomly selected from the eligible patient list in three study venues or countries (i.e., 114 subjects from each study site/ country) and after baseline measurement, be assigned similar to the first phase to one of the three study groups. The patients' mental and psychosocial functioning, insights into illness, and their re-hospitalization rates will be measured at recruitment and at one week, and 6, 12 and 24 months after completing the interventions.
Hypothesis: The patients in the mindfulness-based psycho-education program will report significantly greater improvements in their symptoms and re-hospitalization rates (primary outcomes) and other secondary outcomes (e.g., insight into illness and functioning) over the 24-month follow-up, when compared with those in psycho-education group or usual care.
Conclusions: The findings will provide evidence whether the mindfulness-based psycho-education program can better improve Chinese schizophrenia sufferers' psychosocial functioning and reduce their illness relapse.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-based program | Experimental | Behavioral: Mindfulness-based programA structured, researcher-designed mindfulness-based psycho-education program (6 months), comprised of 12 bi-weekly, 2-hour group sessions (10-12 patients per group). The program was based on the psycho-education programs by Chien et al. (2010) and Lehman et al. (2004), as well as the 8-session Mindfulness-Based Stress Reduction Program by Kabat-Zinn (1990). |
| Routine Care | Other | Other: Routine Care, Behavioral: Mindfulness-based program, Behavioral: Psychoeducation groupRoutine psychiatric outpatient care, including medication, psychiatric consultation in outpatient clinic, brief education by psychiatric nurses, financial and social welfare advices by social workers, and individual counseling by clinical psychologist. |
| Psychoeducation group | Active comparator | Behavioral: Psychoeducation groupA psychoeducation group program (12 sessions, bi-weekly) based on Dr. Macpherson's Family Psychoeducation Program in 1996 and Chien and Bressington's one in 2014/15 will be used. References: Chien WT, Bressington D. A randomized controlled trial of a nurse-led structured psychosocial intervention program for people with first-onset mental illness in psychiatric outpatient clinics. Psychiatry Res 2015;229:277-86. Macpherson R, Jerrom B, Hughes AA. controlled study of education about drug treatment in schizophrenia. Br J Psychiatry 1996;168:709-17. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- outpatients;
- aged 18+; and
- diagnosed as schizophrenia and other psychotic disorders (< or =5 years) according to the Diagnostic and Statistical Manual, 4th edition, as ascertained by the Structured Clinical Interview (SCID-I).
Key exclusion criteria (3 listed)
- not able to understand the psycho-education content and Chinese;
- mentally unstable at recruitment; and
- with co-morbidity of other severe mental health problems such as depression and substance misuse.
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 |
|---|---|---|
| Routine CareAlso: Routine Psychiatric CarePsychiatric outpatient care provided by the outpatient departments, e.g., medical consultation, brief education by psychiatric nurses and financial advices or referrals by social workers. | Other | Routine Care |
| Mindfulness-based programAlso: Mindfulness-based illness management program, Mindfulness-based care for schizophrenia programThe program was based on the psychoeducation programs by Chien et al and Lehman et al, as well as the 8-session Mindfulness-Based Stress Reduction Program by Kabat-Zinn(1990). | Behavioural | Mindfulness-based program, Routine Care |
| Psychoeducation groupAlso: Conventional psychoeducation group, Psychoeducation group interventionA 5-month patient psychoeducation group program (12 sessions) led by the research team will be provided. | Behavioural | Psychoeducation group, Routine Care |
Primary outcome
Rehospitalization rates
Time frame: from recruitment to 24-month follow-up
Average amount (number) and length of hospital stay of the patients over previous six months will be assessed at recruitment and one week, 6 months, 12 months and 24 months after the interventions completed.
Positive and Negative Syndrome Scale
Time frame: from recruitment to 24-month follow-up
The Positive and Negative Syndrome Scale assesses the severity of psychotic symptoms on three subscales: positive symptoms (7 items), negative symptoms (7 items) and general psychopathology (16 items). will be assessed at recruitment and one week, 6 months, 12 months and 24 months after the interventions completed. Symptom remission rate over the follow-up periods are also assessed. Complete remission was defined as 4-month simultaneous ratings of all individual items in PANSS as score ≤3.
1 secondary outcome
insights to illness and treatment
Time frame: from recruitment to 24-month follow-up
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 18 Dec 2019.
- Background: PubMed 23412024Chien WT, Lee IY. The mindfulness-based psychoeducation program for Chinese patients with schizophrenia. Psychiatr Serv. 2013 Apr 1;64(4):376-9. doi: 10.1176/appi.ps.002092012.
- Background: PubMed 24809397Chien WT, Thompson DR. Effects of a mindfulness-based psychoeducation programme for Chinese patients with schizophrenia: 2-year follow-up. Br J Psychiatry. 2014 Jul;205(1):52-9. doi: 10.1192/bjp.bp.113.134635. Epub 2014 May 8.
- BackgroundLam, A.H.Y., & Chien, W.T. (2016). The effectiveness of mindfulness-based intervention for people with schizophrenia: A systematic review. Neuropsychiatry (London), 6(5), 208-222.
- Results publication: PubMed 28374661Chien WT, Bressington D, Yip A, Karatzias T. An international multi-site, randomized controlled trial of a mindfulness-based psychoeducation group programme for people with schizophrenia. Psychol Med. 2017 Sep;47(12):2081-2096. doi: 10.1017/S0033291717000526. Epub 2017 Apr 4.
- 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.
Chien WT, PhD principal investigator
The HK Polytechnic University
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Routine Care, Mindfulness-based program and Psychoeducation group in people with Schizophrenia, run by The Hong Kong Polytechnic University at 4 sites in 3 countries.
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 18 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Hong Kong, China, Taiwan. 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?
Rehospitalization rates (time frame: from recruitment to 24-month follow-up). The study lists 2 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 NCT01667601, 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 18 Dec 2019.