Mindfulness Psychoeducation Program for Schizophrenia

Schizophreniform Disorders Clinical Trial

Official title:

The Effectiveness of a Mindfulness Psychoeducation Program on Emotional Regulation for People With Schizophrenia: A Pilot Randomized Control Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03632278
• Other study ID #: HSEARS20180531001
• Status: Recruiting
• Phase: N/A
• Start date: June 3, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: August 2018
• Source: The Hong Kong Polytechnic University
• Contact: Ho Yan Lam
• Phone: 852 3917 6975
• Email: angielam[@]hku.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 58
• Est. completion date: December 31, 2019
• Est. primary completion date: July 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizophrenia
• Schizophreniform Disorders

Intervention

Behavioral:
• Mindfulness psychoeducation Programme
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.

Locations

Country	Name	City	State
Hong Kong	New Life Assocation	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University	New Life Psychiatric Rehabilitation Association

Country where clinical trial is conducted

Hong Kong, 

References & Publications (12)

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. — View 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/S0033291717000 — View 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. — View 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. — View 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. — View 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. — View 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. — View 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.

Norton PJ. Depression Anxiety and Stress Scales (DASS-21): psychometric analysis across four racial groups. Anxiety Stress Coping. 2007 Sep;20(3):253-65. — View 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. Review. — View 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.

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.

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	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	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.	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	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.	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	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.	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	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.	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	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.	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