- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03632278
Mindfulness Psychoeducation Program for Schizophrenia
The Effectiveness of a Mindfulness Psychoeducation Program on Emotional Regulation for People With Schizophrenia: A Pilot Randomized Control Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ho Yan Lam
- Phone Number: 852 3917 6975
- Email: angielam@hku.hk
Study Locations
-
-
-
Hong Kong, Hong Kong
- Recruiting
- New Life Assocation
-
Contact:
- Cheang Detty
- Phone Number: 2778 4503
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Mindfulness psychoeducation programme
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).
|
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. |
NO_INTERVENTION: Treatment as usual
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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.
|
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
|
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.
|
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
|
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.
|
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
|
It is a single-item scale ranging from 1 to 100, with higher scores indicating higher functioning.
|
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
|
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.
|
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
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Ho Yan Lam, The Hong Kong Polytechnic University
Publications and helpful links
General Publications
- Chien 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.
- 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.
- 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.
- Aldao 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.
- Chien 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.
- Crawford 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.
- Hou 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.
- Norton 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.
- O'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.
- Zhang 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSEARS20180531001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Schizophreniform Disorders
-
Centre for Addiction and Mental HealthNot yet recruitingSchizophrenia | Schizophreniform DisordersCanada
-
University of North Carolina, Chapel HillNational Institute of Mental Health (NIMH)CompletedSchizophreniform DisordersUnited States
-
UMC UtrechtCompletedSchizophrenia | Schizophreniform DisordersNetherlands
-
Bayside HealthCompletedSchizophrenia | Schizoaffective and Schizophreniform DisordersAustralia
-
Pakistan Institute of Living and LearningNot yet recruitingSchizophrenia | Schizoaffective Disorder | Psychosis | Schizophreniform Disorders
-
Centre for Addiction and Mental HealthUniversity of Maryland, Baltimore; National Institutes of Health (NIH); The Feinstein...CompletedSchizophrenia | Schizoaffective Disorder | Schizophreniform DisordersUnited States, Canada
-
SunovionCompletedSchizophrenia, Schizoaffective Disorder, or Schizophreniform DisorderUnited States
-
Tangent DataStanley Medical Research InstituteCompletedSchizophrenia | Schizoaffective Disorder | Schizophreniform DisordersMoldova, Republic of
-
Johnson & Johnson Pharmaceutical Research & Development...CompletedSchizophrenia | Schizoaffective Disorder | Schizophreniform Disorders
-
University of North Carolina, Chapel HillNorth Carolina Department of Health and Human ServicesRecruitingSchizophrenia | Schizoaffective Disorder | Schizophreniform Disorders | Unspecified or Other Psychotic DisordersUnited States
Clinical Trials on Mindfulness psychoeducation Programme
-
Hospital San Carlos, MadridCompleted
-
The Hong Kong Polytechnic UniversityHealth and Medical Research FundNot yet recruitingCaregiving Stress
-
University of Turin, ItalyFondazione Italiana Sclerosi MultiplaCompleted
-
University of Massachusetts, WorcesterNational Center for Complementary and Integrative Health (NCCIH)CompletedObesity | OverweightUnited States
-
University of UtahCompleted
-
Trina E. Chang, MDDupont-WarrenCompletedMajor Depressive DisorderUnited States
-
University of UtahCompleted
-
National Cancer Institute (NCI)CompletedSarcoma | Leukemia | Astrocytoma | Brain Cancer | GlioblastomasUnited States
-
KU LeuvenUniversitaire Ziekenhuizen KU LeuvenUnknown