Mindfulness Intervention for People With Psychosis

NCT03501862 | Completed

• 1 other identifier: HSEARS20170811001
• Study Type: interventional
• Target: 108
• Locations: 2 countries
• Sites: 2

Brief Summary

People with psychosis demonstrated a tendency to use maladaptive cognitive emotion regulation strategies as compared with healthy control groups. The present study is the first randomized controlled trial of group mindfulness-based intervention for psychosis. Half group will join the mindfulness-based cognitive intervention while another half will participate in psychoeducation to examine whether mindfulness will have a positive impact on emotion regulation and distress.

Conditions

Recent-onset Psychosis

Keywords

Mindfulness; Cognitive therapy

Outcome Measures

Primary Outcomes (1)

• The Depression Anxiety Stress Scale - short form (DASS-21)

  ). It is chosen as the primary outcome measurement because scales of anxiety and depression possess the capacity to differentiate from the related state of tension and stress linking with environmental demands and emotional and physical disturbance. It is a 21-item instrument that measures over the past week symptoms of depression, anxiety and stress rated by 4-point severity or frequency scale. The scale is from 0 (did not apply to me at all) to 3 (applied to me very much or most of the time).

  Changes will be assessed pre-study; at one week, 3-month and 6-month post-intervention

Secondary Outcomes (7)

• The Emotion Regulation Questionnaire (ERQ)

  Changes will be assessed pre-study; at one week, 3-month and 6-month post-intervention

• The WHOQOL-100

  Changes will be assessed pre-study; at one week, 3-month and 6-month post-intervention

• Positive and Negative Syndrome Scale (PANSS)

  Changes will be assessed pre-study; at one week, 3-month and 6-month post-intervention

• Acceptance and Action Scale (AAQII)

  Changes will be assessed pre-study; at one week, 3-month and 6-month post-intervention

• Five Facet Mindfulness Questionnaire (FFMQ)

  Changes will be assessed pre-study; at one week, 3-month and 6-month post-intervention

Study Arms (2)

Mindfulness-based intervention

EXPERIMENTAL

Intervention: a twelve 1.5 weekly program on mindfulness-based cognitive therapy (psychosis)

Behavioral: Mindfulness-based cognitive therapy (psychosis)

Psychoeducation

ACTIVE COMPARATOR

Intervention: a twelve 1.5 hours weekly program on psychoeducation (psychosis)

Behavioral: Psychoeducation (psychosis)

Interventions

Mindfulness-based cognitive therapy (psychosis) BEHAVIORAL

A small group intervention is based on a structured and validated protocol that will include mindfulness practice, cognitive skills

Mindfulness-based intervention

Psychoeducation (psychosis) BEHAVIORAL

A small group intervention will be focusing on understanding of psychosis, treatment, relapse prevention and useful information and resources.

Psychoeducation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be Chinese residents and aged above 18
• Have a primary diagnosis of psychosis (non-affective) and/or other psychotic disorders met the Diagnostic and Statistical Manual DSM-5
• Have been diagnosed equivalent to or less than 5 years
• Mentally stable as assessed by the researcher and a psychiatrist to comprehend the education and training provided (a pre-recruitment briefing session for potential participants will be conducted to verify their ability to follow instructions and understanding in participation, and case files will be reviewed to ensure a stable medication regime for at least 6 months) in order to ensure their ability to make a valid consent
• Able to read and understand Chinese

You may not qualify if:

• Have recently participated in (less than 3 months) or are receiving other structured psycho-education and/or psychotherapies
• Have comorbidities (a) developmental impairment (b) learning disability, (c) personality disorders, and/or (d) any clinically significant medical diseases (by case-file review).
• Have organic psychosis or a primary drug or alcohol addiction

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead
• Edinburgh Napier University: collaborator

Study Sites (2)

The Fourth People's Hospital

Chengdu, China

Location

The Society of Rehabilitation and Crime Prevention

Hong Kong, Hong Kong

Location

MeSH Terms

Interventions

Mindfulness-Based Cognitive Therapy

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Thanos Karatzias

  Edinburgh Napier University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assignment to the study groups will be made independently of staff involved in the recruitment and management of participants in the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Clinical Associate

Model Details: Participants referred to the study will be assessed at a screening examination to ensure eligibility and obtain written consent by a research assistant. Eligible participants will undertake a further interview on outcome measures prior to randomization within 3 weeks the commencement of intervention. Eligible participants will be randomly assigned to receive Mindfulness-based Cognitive Therapy for Psychosis (MBCTp) plus TAU or TAU plus Psychoeducation for Psychosis (PEp). Simple randomization will be used to ensure that participants will have equal opportunity to be included into the study (Altaman and Bland, 1999).

Study Record Dates

• First Submitted: March 9, 2018
• First Posted: April 18, 2018
• Study Start: January 15, 2017
• Primary Completion: July 31, 2021
• Study Completion: July 31, 2021
• Last Updated: September 27, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, CSR
• Time Frame: 3-months after publication
• Access Criteria: Request by sending email

Locations

HK (1); CN (1)