Clinical trial NCT03632278: Mindfulness Psychoeducation Program for Schizophrenia
Official title: The Effectiveness of a Mindfulness Psychoeducation Program on Emotional Regulation for People With Schizophrenia: A Pilot Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Schizophreniform Disorders
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
Collaborators: name: New Life Psychiatric Rehabilitation Association
First posted: 2018-08-15
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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.

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:

1. 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.
2. Participants receiving MBPP attain a reduction in depressive/anxiety symptoms compared to a control group after completion of the intervention.
3. These effects are expected to be maintained through 3-month follow up with regular self-practice.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Emotion regulation questionnaire (ERQ)
timeFrame: 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:
measure: Change in Short Ruminative Response Scale (SRRS)
timeFrame: 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
measure: Change in Depression Anxiety Stress Scale (DASS-21)
timeFrame: 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
measure: Change in The Chinese version of the Psychotic Symptom Rating Scale (C-PSYRATS)
timeFrame: 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
measure: Change in Social and Occupational Functioning Assessment Scale (SOFAS)
timeFrame: 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
measure: Change in Five Facet Mindfulness Questionnaire - Short form (FFMQ-SF)
timeFrame: 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
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: New Life Assocation
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Ho Yan Lam
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Zhang H, & Xu Y. Reliability and Validity of the Chinese Short Ruminative Responses Scale (SRRS) in Chinese Undergraduates. Psychological research(3):34-39. 2010.
citation: 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.
citation: Lam AHY, & Chien WT. The effectiveness of mindfulness-based intervention for people with schizophrenia: a systematic review. Neuropsychiatry (London), 6(5): 208-222. 2016.
citation: 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.