Mindfulness Intervention and Relapse in Psychosis

NCT04060498 | Unknown DMC

• 1 other identifier: 17110918
• Study Type: interventional
• Target: 152
• Locations: 0 countries
• Sites: N/A

Brief Summary

Practicing mindfulness is popular and well-accepted for its benefits in improving mental and physical health. In particular, its benefits in promoting resilience to stress and well-being have been shown in studies involving different psychiatric conditions, as well as preventing relapse in patients with depressive disorders. However, its role in relapse prevention among patients with psychosis has not been tested. The investigators therefore propose a multi-site, single-blind, 12-month randomized controlled trial in Hong Kong to examine the effectiveness of mindfulness intervention in prevention of relapse among 152 remitted psychosis patients.

Conditions

Psychosis

Keywords

Mindfulness, Prevention, Relapse, Psychosis, Schizophrenia, Psychotic Disorders, Mental Disorders, Schizophrenia and Disorders with Psychotic Features

Outcome Measures

Primary Outcomes (1)

• Number of participants with psychotic relapse(s)

  Psychotic relapse is defined as an increase in at least one of the following PANSS (Kay et al., 1987) items: delusion and/or hallucinatory behavior to a score of 3 or above; conceptual disorganization or unusual thought content to a score of 4 or above; and suspiciousness to a score of 5 or above.

  12 months post-intervention

Study Arms (2)

Mindfulness intervention

EXPERIMENTAL

This arm consists of seven weekly-session mindfulness-based intervention for psychosis (MBI-p). The MBI-p is a protocol-based, low intensity intervention developed to help patients achieve a greater sense of peace and calmness, and facilitates participants in handling everyday stress and conflicts.

Behavioral: Mindfulness intervention

Psychoeducation intervention

PLACEBO COMPARATOR

This arm consists of seven weekly-sessions of psychoeducation. Topics to be discussed in the sessions include the signs and symptoms of psychosis, aetiology of psychosis, as well as pharmacological and non-pharmacological interventions.

Behavioral: Psychoeducation intervention

Interventions

Mindfulness intervention BEHAVIORAL

MBI-p focuses on simplicity, for both facilitators and patients; and use acceptance and embracing attitude for fear and sadness. The ultimate aims are to help patients achieve a greater sense of peace and calmness, and facilitate participants in handling everyday stress and conflicts.

Mindfulness intervention

Psychoeducation intervention BEHAVIORAL

Psychoeducation focuses on disseminating information about common mental disorders, psychosis (its causes, risk factors and trajectory), and methods of treatment for psychosis.

Psychoeducation intervention

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• aged 18 to 55 years
• in full symptomatic remission for at least 6 months
• have been ill for no more than 3 years following first episode psychosis
• have sufficient proficiency in Chinese to understand verbal instructions and to give informed consent.

You may not qualify if:

• known diagnosis of intellectual disability
• organic brain disorder
• current or previous use of illicit drugs
• substance-induced psychosis or alcohol intake in excess of 5 standard units per day
• people who practice mindfulness and meditation exercise for more than twice a week over the past 1 month.

Sponsors & Collaborators

• The University of Hong Kong: lead
• University Grants Committee, Hong Kong: collaborator

Related Publications (3)

• Guy W (1976). Clinical global impression scale (CGI). In Guy W. editors. ECDEU assessment manual for psychopharmacology, Revised. Rockville MD: US Dept of Health, Education and Welfare, National Institute of Mental Health. Page 217-222.

  BACKGROUND

• Kay SR, Fiszbein A, Opler LA. The positive and negative syndrome scale (PANSS) for schizophrenia. Schizophr Bull. 1987;13(2):261-76. doi: 10.1093/schbul/13.2.261.

  PMID: 3616518 BACKGROUND

• Hui CLM, Wong CCL, Lui ECY, Chiu TC, Tao TJ, Chan EWT, Lin J, Tong ACY, Suen YN, Chan CWH, Yeung WS, Lee EHM, Chan SKW, Chang WC, Chen EYH. Effects of mindfulness-based intervention in preventing relapse in patients with remitted psychosis: a randomized controlled trial. Schizophrenia (Heidelb). 2024 Dec 20;10(1):120. doi: 10.1038/s41537-024-00539-0.

  PMID: 39702769 DERIVED

MeSH Terms

Conditions

Psychotic Disorders; Recurrence; Schizophrenia; Mental Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Christy Lai-ming Hui, Dr

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christy Lai-ming Hui, Dr

CONTACT

+852 2255 3064; christy@lmhui.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2019
• First Posted: August 19, 2019
• Study Start: October 1, 2019
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: September 20, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share