Mindfulness Intervention for People With Psychosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-15

Study Completion Date

2021-07-31

Brief Summary

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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.

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Detailed Description

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Concurrently with positive and negative symptoms, affective symptoms and full affective disorder episodes are common in psychotic disorders particularly in the acute phase of illness.

Affective symptoms are a significant risk factor accounting for approximately 5-6% of suicide rates which remain or becomes higher shortly after a psychotic episode or hospital discharge (American Psychiatric Association, 2013). It has been proved that the emotion management and cognitive reappraisal were negatively associated with schizophrenia.

In the study, it is hypothesized that the intervention will have a positive impact on psychotic symptoms, general symptoms such as affective symptoms, psychological flexibility, mindfulness skills, quality of life and re-hospitalization by facilitating strategies on emotion regulation.

Conditions

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Recent-onset Psychosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Assignment to the study groups will be made independently of staff involved in the recruitment and management of participants in the study.

Study Groups

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Mindfulness-based intervention

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

Group Type EXPERIMENTAL

Mindfulness-based cognitive therapy (psychosis)

Intervention Type BEHAVIORAL

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

Psychoeducation

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

Group Type ACTIVE_COMPARATOR

Psychoeducation (psychosis)

Intervention Type BEHAVIORAL

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

Interventions

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Mindfulness-based cognitive therapy (psychosis)

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

Intervention Type BEHAVIORAL

Psychoeducation (psychosis)

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No