Mindfulness-based Illness Management Program for Schizophrenia

NCT01667601 | Completed DMC

• 1 other identifier: HSEARS20121211001
• Study Type: interventional
• Target: 449
• Locations: 3 countries
• Sites: 4

Brief Summary

Only a few intervention studies have also focused on changing patients' negative thoughts and feelings towards the illness and their relationship to the suffering caused by those thoughts, which is evidenced to empower psychosocial functioning and control of distressing thoughts in severe depression and psychotic disorders by using the Mindfulness-Based Stress Reduction program. This controlled trial is designed to test the effects of a mindfulness-based Illness management program (MBPP) for Chinese patients with schizophrenia on their symptom severity, illness insight and psychosocial functioning.

Conditions

Schizophrenia

Keywords

mindfulness-based program; Psychoeducation; schizophrenia; Chinese; outpatients

Outcome Measures

Primary Outcomes (2)

• Rehospitalization rates

  Average amount (number) and length of hospital stay of the patients over previous six months will be assessed at recruitment and one week, 6 months, 12 months and 24 months after the interventions completed.

  from recruitment to 24-month follow-up

• Positive and Negative Syndrome Scale

  The Positive and Negative Syndrome Scale assesses the severity of psychotic symptoms on three subscales: positive symptoms (7 items), negative symptoms (7 items) and general psychopathology (16 items). will be assessed at recruitment and one week, 6 months, 12 months and 24 months after the interventions completed. Symptom remission rate over the follow-up periods are also assessed. Complete remission was defined as 4-month simultaneous ratings of all individual items in PANSS as score ≤3.

  from recruitment to 24-month follow-up

Secondary Outcomes (1)

• insights to illness and treatment

  from recruitment to 24-month follow-up

Other Outcomes (2)

• Specific Level of Functioning Scale

  from recruitment to 24-month follow-up

• Six-item Social Support Questionnaire

  from recruitment to 24-month follow-up

Study Arms (3)

Mindfulness-based program

EXPERIMENTAL

A structured, researcher-designed mindfulness-based psycho-education program (6 months), comprised of 12 bi-weekly, 2-hour group sessions (10-12 patients per group). The program was based on the psycho-education programs by Chien et al. (2010) and Lehman et al. (2004), as well as the 8-session Mindfulness-Based Stress Reduction Program by Kabat-Zinn (1990).

Behavioral: Mindfulness-based program

Routine Care

OTHER

Routine psychiatric outpatient care, including medication, psychiatric consultation in outpatient clinic, brief education by psychiatric nurses, financial and social welfare advices by social workers, and individual counseling by clinical psychologist.

Other: Routine Care; Behavioral: Mindfulness-based program; Behavioral: Psychoeducation group

Psychoeducation group

ACTIVE COMPARATOR

A psychoeducation group program (12 sessions, bi-weekly) based on Dr. Macpherson's Family Psychoeducation Program in 1996 and Chien and Bressington's one in 2014/15 will be used. References: Chien WT, Bressington D. A randomized controlled trial of a nurse-led structured psychosocial intervention program for people with first-onset mental illness in psychiatric outpatient clinics. Psychiatry Res 2015;229:277-86. Macpherson R, Jerrom B, Hughes AA. controlled study of education about drug treatment in schizophrenia. Br J Psychiatry 1996;168:709-17.

Behavioral: Psychoeducation group

Interventions

Routine Care OTHER

Psychiatric outpatient care provided by the outpatient departments, e.g., medical consultation, brief education by psychiatric nurses and financial advices or referrals by social workers.

Also known as: Routine Psychiatric Care

Routine Care

Mindfulness-based program BEHAVIORAL

The program was based on the psychoeducation programs by Chien et al and Lehman et al, as well as the 8-session Mindfulness-Based Stress Reduction Program by Kabat-Zinn(1990).

Also known as: Mindfulness-based illness management program, Mindfulness-based care for schizophrenia program

Mindfulness-based program; Routine Care

Psychoeducation group BEHAVIORAL

A 5-month patient psychoeducation group program (12 sessions) led by the research team will be provided.

Also known as: Conventional psychoeducation group, Psychoeducation group intervention

Psychoeducation group; Routine Care

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• outpatients;
• aged 18+; and
• diagnosed as schizophrenia and other psychotic disorders (\< or =5 years) according to the Diagnostic and Statistical Manual, 4th edition, as ascertained by the Structured Clinical Interview (SCID-I).

You may not qualify if:

• not able to understand the psycho-education content and Chinese;
• mentally unstable at recruitment; and
• with co-morbidity of other severe mental health problems such as depression and substance misuse.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead
• Hospital Authority, Hong Kong: collaborator
• Jilin Medical College, China: collaborator
• Taipei Medical University, Taiwan: collaborator

Study Sites (4)

Jilin Medical College

Jilin, Jilin, 0432, China

Location

KH/LKS Specialty OPD

Shatin, NT, Hong Kong

Location

TM Psy Centre

Tuenmen, NT, Hong Kong

Location

Taipei Medical University

Taipei, Xinyi, Taiwan

Location

Related Publications (4)

• Chien WT, Lee IY. The mindfulness-based psychoeducation program for Chinese patients with schizophrenia. Psychiatr Serv. 2013 Apr 1;64(4):376-9. doi: 10.1176/appi.ps.002092012.

  PMID: 23412024 BACKGROUND

• 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.

  PMID: 24809397 BACKGROUND

• Lam, A.H.Y., & Chien, W.T. (2016). The effectiveness of mindfulness-based intervention for people with schizophrenia: A systematic review. Neuropsychiatry (London), 6(5), 208-222.

  BACKGROUND

• 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.

  PMID: 28374661 RESULT

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Chien WT, PhD

  The HK Polytechnic University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 15, 2012
• First Posted: August 17, 2012
• Study Start: August 1, 2010
• Primary Completion: June 1, 2016
• Study Completion: April 1, 2017
• Last Updated: December 18, 2019

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1); TW (1); HK (2)