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Mindfulness Psychoeducation Program for Schizophrenia

Primary Purpose

Schizophreniform Disorders

Status
Unknown status
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Mindfulness psychoeducation Programme
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophreniform Disorders

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • New Life AssocationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Mindfulness psychoeducation programme

Treatment as usual

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
June 15, 2018
Last Updated
August 14, 2018
Sponsor
The Hong Kong Polytechnic University
Collaborators
New Life Psychiatric Rehabilitation Association
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1. Study Identification

Unique Protocol Identification Number
NCT03632278
Brief Title
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

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 3, 2018 (Actual)
Primary Completion Date
July 30, 2019 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University
Collaborators
New Life Psychiatric Rehabilitation Association

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophreniform Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Allocation
Randomized
Enrollment
58 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness psychoeducation programme
Arm Type
Experimental
Arm Description
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).
Arm Title
Treatment as usual
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness psychoeducation Programme
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Emotion regulation questionnaire (ERQ)
Description
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).
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
Secondary Outcome Measure Information:
Title
Change in Short Ruminative Response Scale (SRRS)
Description
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.
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
Title
Change in Depression Anxiety Stress Scale (DASS-21)
Description
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.
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
Title
Change in The Chinese version of the Psychotic Symptom Rating Scale (C-PSYRATS)
Description
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.
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
Title
Change in Social and Occupational Functioning Assessment Scale (SOFAS)
Description
It is a single-item scale ranging from 1 to 100, with higher scores indicating higher functioning.
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
Title
Change in Five Facet Mindfulness Questionnaire - Short form (FFMQ-SF)
Description
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.
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ho Yan Lam
Phone
852 3917 6975
Email
angielam@hku.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ho Yan Lam
Organizational Affiliation
The Hong Kong Polytechnic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
New Life Assocation
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cheang Detty
Phone
2778 4503

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
18489225
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.
Results Reference
background
PubMed Identifier
20015584
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.
Results Reference
background
PubMed Identifier
28331325
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.
Results Reference
background
PubMed Identifier
24809397
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.
Results Reference
background
PubMed Identifier
12828802
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.
Results Reference
background
PubMed Identifier
23596271
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.
Results Reference
background
PubMed Identifier
17999228
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.
Results Reference
background
PubMed Identifier
25105273
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.
Results Reference
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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.
Results Reference
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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.
Results Reference
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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.
Results Reference
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PubMed Identifier
28374661
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. Erratum In: Psychol Med. 2023 Apr;53(6):2720.
Results Reference
result

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Mindfulness Psychoeducation Program for Schizophrenia

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