Schizophreniform DisordersNCT03632278
Mindfulness Psychoeducation Program for Schizophrenia
A study testing Mindfulness psychoeducation Programme in people with Schizophreniform Disorders, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
The study is the first pilot randomised controlled trial (RCT) to explore the feasibility and efficacy of Mindfulness-based psychoeducation in emotion regulation and related depressive and anxiety symptoms in people with schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophreniform Disorders
- What is being tested?
- Mindfulness psychoeducation Programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteHong Kong
- Study dates
- 3 Jun 2018to 31 Dec 2019
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years to 65 years old
- Diagnosis with schizophrenia-spectrum disorders according to the criteria of the Diagnostic and Statistical Manual for Mental Disorders DSM-IV-TR (and the latest DSM-V) or International Classification of Diseases (ICD-10)-Classification of Mental Disorders
- Able to communicate in written and conversational Chinese/Cantonese
- Able to understand the concepts of the study and to give informed consent
Who cannot join
- Comorbid organic brain disorders or substance abuse
- Participation in any forms of cognitive therapy
- Participation and/or practice of mindfulness (in the forms of Tai Chi, Qi Gong, etc.) more than twice a week during the previous three months
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
New Life Assocation
Hong Kong
Cheang Detty, 2778 4503
About this study
Official title: The Effectiveness of a Mindfulness Psychoeducation Program on Emotional Regulation for People With Schizophrenia: A Pilot Randomized Control Trial
The study is the first pilot randomised controlled trial (RCT) to explore the feasibility and efficacy of Mindfulness-based psychoeducation in emotion regulation and related depressive and anxiety symptoms in people with schizophrenia.
Read the detailed description
There is increasing evidence to demonstrate the safety and effectiveness of mindfulness-based psychoeducation programme (MBPP) for Chinese people with schizophrenia. A single-blind, multi-site, pragmatic randomised controlled trial conducted in Hong Kong, mainland China, and Taiwan with 300 participants consistently demonstrated significant improvement in regard to insight of illness, functioning, mental state and the length of re-hospitalisations when compared with conventional psychoeducation and Treatment As Usual (TAU) groups (Chien, 2017).
The study hypothesises that:
- Participants receiving MBPP will decrease their use of rumination and expressive suppression, and increase the use of cognitive reappraisal compared to a control group after completion of the intervention.
- Participants receiving MBPP attain a reduction in depressive/anxiety symptoms compared to a control group after completion of the intervention.
- These effects are expected to be maintained through 3-month follow up with regular self-practice.
- Conditions
- Schizophreniform Disorders
- Being tested
- Mindfulness psychoeducation Programme
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness psychoeducation ProgrammeBehavioural
A MBPP will be conducted for 2 hours for each session, one a week for eight weeks. The protocol has been developed based on the model of mindfulness-based stress reduction proposed by Kabat-Zinn (1994) and Tong et al. (2015), and the psychoeducation programmes by Chien and Lee, and Lehman and colleagues (Chien \& Lee, 2010; Kabat-Zinn et al., 1992; Lehman et al., 2004; Tong et al., 2015).
The programme will be integration of mindfulness and psychoeducation to cultivate the client's mindfulness attitude. The clients will learn to apply the mindfulness in illness management and daily difficulties.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness psychoeducation programme | Experimental | A MBPP will be conducted for 2 hours for each session, one a week for ten weeks, with 13-15 participants per group. The protocol has been developed based on the model of mindfulness-based stress reduction proposed by Kabat-Zinn (1994) and Tong et al. (2015), and the psychoeducation programmes by Chien and Lee, and Lehman and colleagues (Chien \& Lee, 2010; Kabat-Zinn et al., 1992; Lehman et al., 2004; Tong et al., 2015). Receives: Behavioral: Mindfulness psychoeducation Programme |
| Treatment as usual | No intervention | The usual care group will receive routine psychiatric outpatient services, including monthly psychiatric consultation and treatment by a psychiatrist, psychiatric nursing advice and brief education according to the patient's psychosocial needs. There will be community mental health services, social welfare or financial assistance supported by medical social workers, whenever necessary. Participants in this control may be aware that they are receiving no extra treatment which may result in negative expectancies and inflation of the treatment effect (Stoney \& Johnson, 2012). To eliminate the time effect and artificially inflated intervention effect, patients in the control group will receive telephone contact once a week to discuss their disease process and daily issues. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Emotion regulation questionnaire (ERQ)
This is a self-report questionnaire that measures two different emotion regulation patterns: cognitive reappraisal and expressive suppression. The questionnaire has 10 items: six items reflect the reappraisal factor and four items reflect the suppressive factor. The 10 items are rated on a scale from 1 (strongly disagree) to 7 (strongly agree).
Measured: Clients will be followed up and assessed at baseline, immediately after 8 weeks of MBI intervention (post-intervention), and 3 months post-intervention by the assessor who will be blind to participant allocation
Secondary outcomes (5)
Change in Short Ruminative Response Scale (SRRS)
It comprises 10 items that are symptom-focused, self-focused, or focused on the possible causes and consequences of the depressive mood. Participants will be asked to rate on a four-point Likert scale, resulting in a possible range of scores from 22 to 88, with a higher score implying a higher level of rumination.
Measured: Clients will be followed up and assessed at baseline, immediately after 8 weeks of MBI intervention (post-intervention), and 3 months post-intervention by the assessor who will be blind to participant allocation
Change in Depression Anxiety Stress Scale (DASS-21)
This instrument comprises three subscales including Depression, Anxiety, and Stress. The Depression scale assesses dysphoria, hopelessness, devaluation of life, self-deprecation, lack of interest or involvement, anhedonia and inertia. The Anxiety scale assesses autonomic arousal, skeletal muscle effects, situational anxiety and subjective experience of anxious affect. The stress scale is sensitive to levels of chronic non-specific arousal. Each subscale consists of seven items. The severity ratings are made on a series of 4-point (0 to 3) scales (0 = did not apply to me at all, 3 = applied to me very much, or most of the time). The higher the subscale scores the more severe the symptoms.
Measured: Clients will be followed up and assessed at baseline, immediately after 8 weeks of MBI intervention (post-intervention), and 3 months post-intervention by the assessor who will be blind to participant allocation
Change in The Chinese version of the Psychotic Symptom Rating Scale (C-PSYRATS)
C-PSYRATS consists of 17 items assessing the specific dimensions of hallucinations and delusions, with each item being rated on a 5-point scale from 0 (Absent) to 4 (Severe/Often/Extreme). There are two subscales including the auditory hallucinations subscale (AHS) consisting of 11 items, and the delusions subscale (DS) composed six items. The scale measures the subjective characteristics of AHS and DS including their nature, persistence, amount, distress, disruption and controllability toward the symptoms.
Measured: Clients will be followed up and assessed at baseline, immediately after 8 weeks of MBI intervention (post-intervention), and 3 months post-intervention by the assessor who will be blind to participant allocation
Change in Social and Occupational Functioning Assessment Scale (SOFAS)
It is a single-item scale ranging from 1 to 100, with higher scores indicating higher functioning.
Measured: Clients will be followed up and assessed at baseline, immediately after 8 weeks of MBI intervention (post-intervention), and 3 months post-intervention by the assessor who will be blind to participant allocation
Change in Five Facet Mindfulness Questionnaire - Short form (FFMQ-SF)
The FFMQ-SF is a 20-item questionnaire that measures five facets of mindfulness including observing, describing, acting with awareness, nonjudging, and non-reacting (Baer, Smith, Hopkins, Krietemeyer, \& Toney, 2006). Items are scored on a 5-point scale ranging from 1 (never/very rarely true) to 5 (very often/always true). Higher scores indicate greater levels of mindfulness.
Measured: Clients will be followed up and assessed at baseline, immediately after 8 weeks of MBI intervention (post-intervention), and 3 months post-intervention by the assessor who will be blind to participant allocation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study start3 Jun 2018
- Primary completion30 Jul 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Schizophreniform DisordersStudies 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
- Model description
- Participants referred to the study will be assessed at a screening examination to ensure eligibility and obtain written consent from a research assistant. Eligible participants will be randomly assigned to receive Mindfulness psychoeducation programme (MBPP) plus TAU or TAU.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- New Life Psychiatric Rehabilitation Association
- Responsible party
- Principal investigator, LAM Ho Yan, The Hong Kong Polytechnic University
- Investigators
- Ho Yan Lam, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03632278
- Sponsor's protocol ID
- HSEARS20180531001
- Status last verified
- Aug 2018
- First submitted
- 15 Jun 2018
- Last updated
- 15 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Henry JD, Rendell PG, Green MJ, McDonald S, O'Donnell M. Emotion regulation in schizophrenia: affective, social, and clinical correlates of suppression and reappraisal. J Abnorm Psychol. 2008 May;117(2):473-478. doi: 10.1037/0021-843X.117.2.473.
PubMed 18489225Aldao A, Nolen-Hoeksema S, Schweizer S. Emotion-regulation strategies across psychopathology: A meta-analytic review. Clin Psychol Rev. 2010 Mar;30(2):217-37. doi: 10.1016/j.cpr.2009.11.004. Epub 2009 Nov 20.
PubMed 20015584Chien WT, Lee IY, Wang LQ. A Chinese version of the Psychotic Symptom Rating Scales: psychometric properties in recent-onset and chronic psychosis. Neuropsychiatr Dis Treat. 2017 Mar 8;13:745-753. doi: 10.2147/NDT.S131174. eCollection 2017.
PubMed 28331325Chien 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 24809397Crawford JR, Henry JD. The Depression Anxiety Stress Scales (DASS): normative data and latent structure in a large non-clinical sample. Br J Clin Psychol. 2003 Jun;42(Pt 2):111-31. doi: 10.1348/014466503321903544.
PubMed 12828802Hou J, Wong SY, Lo HH, Mak WW, Ma HS. Validation of a Chinese version of the Five Facet Mindfulness Questionnaire in Hong Kong and development of a short form. Assessment. 2014 Jun;21(3):363-71. doi: 10.1177/1073191113485121. Epub 2013 Apr 16.
PubMed 23596271Norton PJ. Depression Anxiety and Stress Scales (DASS-21): psychometric analysis across four racial groups. Anxiety Stress Coping. 2007 Sep;20(3):253-65. doi: 10.1080/10615800701309279.
PubMed 17999228O'Driscoll C, Laing J, Mason O. Cognitive emotion regulation strategies, alexithymia and dissociation in schizophrenia, a review and meta-analysis. Clin Psychol Rev. 2014 Aug;34(6):482-95. doi: 10.1016/j.cpr.2014.07.002. Epub 2014 Jul 24.
PubMed 25105273Zhang H, & Xu Y. Reliability and Validity of the Chinese Short Ruminative Responses Scale (SRRS) in Chinese Undergraduates. Psychological research(3):34-39. 2010.
Zhao X, Zhang BR, Zhang HP, Pan L, & Zhou RL. Reliability and validity of emotion regulation questionnaire in middle school students. Chinese Journal of Clinical Psychology(1). 2015.
Lam AHY, & Chien WT. The effectiveness of mindfulness-based intervention for people with schizophrenia: a systematic review. Neuropsychiatry (London), 6(5): 208-222. 2016.
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 15 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of a Mindfulness Psychoeducation Program on Emotional Regulation for People With Schizophrenia: A Pilot Randomized Control Trial
- ClinicalTrials.gov ID
- NCT03632278
- Acronym / sponsor ID
- HSEARS20180531001
- Conditions
- Schizophreniform Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- New Life Psychiatric Rehabilitation Association
- Study start
- 3 Jun 2018 (actual)
- Primary completion
- 30 Jul 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 15 Aug 2018 (actual)
- 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 study is the first pilot randomised controlled trial (RCT) to explore the feasibility and efficacy of Mindfulness-based psychoeducation in emotion regulation and related depressive and anxiety symptoms in people with schizophrenia.
Detailed description
There is increasing evidence to demonstrate the safety and effectiveness of mindfulness-based psychoeducation programme (MBPP) for Chinese people with schizophrenia. A single-blind, multi-site, pragmatic randomised controlled trial conducted in Hong Kong, mainland China, and Taiwan with 300 participants consistently demonstrated significant improvement in regard to insight of illness, functioning, mental state and the length of re-hospitalisations when compared with conventional psychoeducation and Treatment As Usual (TAU) groups (Chien, 2017).
The study hypothesises that:
- Participants receiving MBPP will decrease their use of rumination and expressive suppression, and increase the use of cognitive reappraisal compared to a control group after completion of the intervention.
- Participants receiving MBPP attain a reduction in depressive/anxiety symptoms compared to a control group after completion of the intervention.
- These effects are expected to be maintained through 3-month follow up with regular self-practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants referred to the study will be assessed at a screening examination to ensure eligibility and obtain written consent from a research assistant. Eligible participants will be randomly assigned to receive Mindfulness psychoeducation programme (MBPP) plus TAU or TAU.
| Arm | Type | Receives |
|---|---|---|
| Mindfulness psychoeducation programme | Experimental | Behavioral: Mindfulness psychoeducation ProgrammeA MBPP will be conducted for 2 hours for each session, one a week for ten weeks, with 13-15 participants per group. The protocol has been developed based on the model of mindfulness-based stress reduction proposed by Kabat-Zinn (1994) and Tong et al. (2015), and the psychoeducation programmes by Chien and Lee, and Lehman and colleagues (Chien \& Lee, 2010; Kabat-Zinn et al., 1992; Lehman et al., 2004; Tong et al., 2015). |
| Treatment as usual | No intervention | –The usual care group will receive routine psychiatric outpatient services, including monthly psychiatric consultation and treatment by a psychiatrist, psychiatric nursing advice and brief education according to the patient's psychosocial needs. There will be community mental health services, social welfare or financial assistance supported by medical social workers, whenever necessary. Participants in this control may be aware that they are receiving no extra treatment which may result in negative expectancies and inflation of the treatment effect (Stoney \& Johnson, 2012). To eliminate the time effect and artificially inflated intervention effect, patients in the control group will receive telephone contact once a week to discuss their disease process and daily issues. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18 years to 65 years old
- Diagnosis with schizophrenia-spectrum disorders according to the criteria of the Diagnostic and Statistical Manual for Mental Disorders DSM-IV-TR (and the latest DSM-V) or International Classification of Diseases (ICD-10)-Classification of Mental Disorders
- Able to communicate in written and conversational Chinese/Cantonese
- Able to understand the concepts of the study and to give informed consent
Key exclusion criteria (3 listed)
- Comorbid organic brain disorders or substance abuse
- Participation in any forms of cognitive therapy
- Participation and/or practice of mindfulness (in the forms of Tai Chi, Qi Gong, etc.) more than twice a week during the previous 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 |
|---|---|---|
| Mindfulness psychoeducation ProgrammeA MBPP will be conducted for 2 hours for each session, one a week for eight weeks. The protocol has been developed based on the model of mindfulness-based stress reduction proposed by Kabat-Zinn (1994) and Tong et al. (2015), and the psychoeducation programmes by Chien and Lee, and Lehman and colleagues (Chien \& Lee, 2010; Kabat-Zinn et al., 1992; Lehman et al., 2004; Tong et al., 2015). The programme will be integration of mindfulness and psychoeducation to cultivate the client's mindfulness attitude. The clients will learn to apply the mindfulness in illness management and daily difficulties. | Behavioural | Mindfulness psychoeducation programme |
Primary outcome
Change in Emotion regulation questionnaire (ERQ)
Time frame: Clients will be followed up and assessed at baseline, immediately after 8 weeks of MBI intervention (post-intervention), and 3 months post-intervention by the assessor who will be blind to participant allocation
This is a self-report questionnaire that measures two different emotion regulation patterns: cognitive reappraisal and expressive suppression. The questionnaire has 10 items: six items reflect the reappraisal factor and four items reflect the suppressive factor. The 10 items are rated on a scale from 1 (strongly disagree) to 7 (strongly agree).
5 secondary outcomes
Change in Short Ruminative Response Scale (SRRS)
Time frame: Clients will be followed up and assessed at baseline, immediately after 8 weeks of MBI intervention (post-intervention), and 3 months post-intervention by the assessor who will be blind to participant allocation
Change in Depression Anxiety Stress Scale (DASS-21)
Time frame: Clients will be followed up and assessed at baseline, immediately after 8 weeks of MBI intervention (post-intervention), and 3 months post-intervention by the assessor who will be blind to participant allocation
Change in The Chinese version of the Psychotic Symptom Rating Scale (C-PSYRATS)
Time frame: Clients will be followed up and assessed at baseline, immediately after 8 weeks of MBI intervention (post-intervention), and 3 months post-intervention by the assessor who will be blind to participant allocation
Change in Social and Occupational Functioning Assessment Scale (SOFAS)
Time frame: Clients will be followed up and assessed at baseline, immediately after 8 weeks of MBI intervention (post-intervention), and 3 months post-intervention by the assessor who will be blind to participant allocation
Change in Five Facet Mindfulness Questionnaire - Short form (FFMQ-SF)
Time frame: Clients will be followed up and assessed at baseline, immediately after 8 weeks of MBI intervention (post-intervention), and 3 months post-intervention by the assessor who will be blind to participant allocation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2018.
- Background: PubMed 18489225Henry JD, Rendell PG, Green MJ, McDonald S, O'Donnell M. Emotion regulation in schizophrenia: affective, social, and clinical correlates of suppression and reappraisal. J Abnorm Psychol. 2008 May;117(2):473-478. doi: 10.1037/0021-843X.117.2.473.
- Background: PubMed 20015584Aldao A, Nolen-Hoeksema S, Schweizer S. Emotion-regulation strategies across psychopathology: A meta-analytic review. Clin Psychol Rev. 2010 Mar;30(2):217-37. doi: 10.1016/j.cpr.2009.11.004. Epub 2009 Nov 20.
- Background: PubMed 28331325Chien WT, Lee IY, Wang LQ. A Chinese version of the Psychotic Symptom Rating Scales: psychometric properties in recent-onset and chronic psychosis. Neuropsychiatr Dis Treat. 2017 Mar 8;13:745-753. doi: 10.2147/NDT.S131174. eCollection 2017.
- 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.
- Background: PubMed 12828802Crawford JR, Henry JD. The Depression Anxiety Stress Scales (DASS): normative data and latent structure in a large non-clinical sample. Br J Clin Psychol. 2003 Jun;42(Pt 2):111-31. doi: 10.1348/014466503321903544.
- Background: PubMed 23596271Hou J, Wong SY, Lo HH, Mak WW, Ma HS. Validation of a Chinese version of the Five Facet Mindfulness Questionnaire in Hong Kong and development of a short form. Assessment. 2014 Jun;21(3):363-71. doi: 10.1177/1073191113485121. Epub 2013 Apr 16.
- Background: PubMed 17999228Norton PJ. Depression Anxiety and Stress Scales (DASS-21): psychometric analysis across four racial groups. Anxiety Stress Coping. 2007 Sep;20(3):253-65. doi: 10.1080/10615800701309279.
- Background: PubMed 25105273O'Driscoll C, Laing J, Mason O. Cognitive emotion regulation strategies, alexithymia and dissociation in schizophrenia, a review and meta-analysis. Clin Psychol Rev. 2014 Aug;34(6):482-95. doi: 10.1016/j.cpr.2014.07.002. Epub 2014 Jul 24.
- BackgroundZhang H, & Xu Y. Reliability and Validity of the Chinese Short Ruminative Responses Scale (SRRS) in Chinese Undergraduates. Psychological research(3):34-39. 2010.
- BackgroundZhao X, Zhang BR, Zhang HP, Pan L, & Zhou RL. Reliability and validity of emotion regulation questionnaire in middle school students. Chinese Journal of Clinical Psychology(1). 2015.
- BackgroundLam AHY, & Chien WT. The effectiveness of mindfulness-based intervention for people with schizophrenia: a systematic review. Neuropsychiatry (London), 6(5): 208-222. 2016.
- 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.
Ho Yan Lam principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness psychoeducation Programme in people with Schizophreniform Disorders, run by The Hong Kong Polytechnic University at 1 site 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: status not confirmed, as of the sponsor's last update on 15 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ho Yan Lam (852 3917 6975, angielam@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Emotion regulation questionnaire (ERQ) (time frame: Clients will be followed up and assessed at baseline, immediately after 8 weeks of MBI intervention (post-intervention), and 3 months post-intervention by the assessor who will be blind to participant allocation). 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 NCT03632278, which also lists 12 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 15 Aug 2018.