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Mindfulness Intervention for People With Psychosis

Primary Purpose

Recent-onset Psychosis

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Mindfulness-based cognitive therapy (psychosis)
Psychoeducation (psychosis)
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recent-onset Psychosis focused on measuring Mindfulness, Cognitive therapy

Eligibility Criteria

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

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

Sites / Locations

  • The Fourth People's Hospital
  • The Society of Rehabilitation and Crime Prevention

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mindfulness-based intervention

Psychoeducation

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

The Emotion Regulation Questionnaire (ERQ)
It is a 10-item scale that was developed to measure participants' tendency to regulate their emotions in cognitive reappraisal and expressive suppression. Items are scored on a 7- point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree).
The WHOQOL-100
It is a self-administered questionnaire consisting of 100 items and among them, there are six domains: physical, psychological, level of independence, social relationship and environmental and spirituality.
Positive and Negative Syndrome Scale (PANSS)
It is a 30-item, 7-point scale measuring positive and negative syndrome, differentiation of clinical symptoms and severity of illness. The seven rating points represent increasing levels of psychopathology from 1 (absent) to 7 (extreme).
Acceptance and Action Scale (AAQII)
A seven-item questionnaire that is a commonly used self-report measure of experiential avoidance which also measures psychological inflexibility. The items are rated on a 7-point Likert scale from 1 (never true) to 7 (always true).
Five Facet Mindfulness Questionnaire (FFMQ)
It is a 39-item self-report questionnaire that measures five facets of mindfulness: observing; describing; acting with awareness; non-judging and non-reacting. Items are scored on a 5-point Likert scale ranging from 1 (never or very rarely true) to 5 (very often or always true).
The number of re-hospitalization
To collect information from both the case files and self-reporting
The length of re-hospitalization
To collect information from both the case files and self-reporting

Full Information

First Posted
March 9, 2018
Last Updated
September 20, 2021
Sponsor
The Hong Kong Polytechnic University
Collaborators
Edinburgh Napier University
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1. Study Identification

Unique Protocol Identification Number
NCT03501862
Brief Title
Mindfulness Intervention for People With Psychosis
Official Title
Mindfulness-based Interventions for People With Recent-onset Psychosis: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
January 15, 2017 (Actual)
Primary Completion Date
July 31, 2021 (Actual)
Study Completion Date
July 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University
Collaborators
Edinburgh Napier University

4. Oversight

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

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recent-onset Psychosis
Keywords
Mindfulness, Cognitive therapy

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 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).
Masking
Outcomes Assessor
Masking Description
Assignment to the study groups will be made independently of staff involved in the recruitment and management of participants in the study.
Allocation
Randomized
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness-based intervention
Arm Type
Experimental
Arm Description
Intervention: a twelve 1.5 weekly program on mindfulness-based cognitive therapy (psychosis)
Arm Title
Psychoeducation
Arm Type
Active Comparator
Arm Description
Intervention: a twelve 1.5 hours weekly program on psychoeducation (psychosis)
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-based cognitive therapy (psychosis)
Intervention Description
A small group intervention is based on a structured and validated protocol that will include mindfulness practice, cognitive skills
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducation (psychosis)
Intervention Description
A small group intervention will be focusing on understanding of psychosis, treatment, relapse prevention and useful information and resources.
Primary Outcome Measure Information:
Title
The Depression Anxiety Stress Scale - short form (DASS-21)
Description
). 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).
Time Frame
Changes will be assessed pre-study; at one week, 3-month and 6-month post-intervention
Secondary Outcome Measure Information:
Title
The Emotion Regulation Questionnaire (ERQ)
Description
It is a 10-item scale that was developed to measure participants' tendency to regulate their emotions in cognitive reappraisal and expressive suppression. Items are scored on a 7- point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree).
Time Frame
Changes will be assessed pre-study; at one week, 3-month and 6-month post-intervention
Title
The WHOQOL-100
Description
It is a self-administered questionnaire consisting of 100 items and among them, there are six domains: physical, psychological, level of independence, social relationship and environmental and spirituality.
Time Frame
Changes will be assessed pre-study; at one week, 3-month and 6-month post-intervention
Title
Positive and Negative Syndrome Scale (PANSS)
Description
It is a 30-item, 7-point scale measuring positive and negative syndrome, differentiation of clinical symptoms and severity of illness. The seven rating points represent increasing levels of psychopathology from 1 (absent) to 7 (extreme).
Time Frame
Changes will be assessed pre-study; at one week, 3-month and 6-month post-intervention
Title
Acceptance and Action Scale (AAQII)
Description
A seven-item questionnaire that is a commonly used self-report measure of experiential avoidance which also measures psychological inflexibility. The items are rated on a 7-point Likert scale from 1 (never true) to 7 (always true).
Time Frame
Changes will be assessed pre-study; at one week, 3-month and 6-month post-intervention
Title
Five Facet Mindfulness Questionnaire (FFMQ)
Description
It is a 39-item self-report questionnaire that measures five facets of mindfulness: observing; describing; acting with awareness; non-judging and non-reacting. Items are scored on a 5-point Likert scale ranging from 1 (never or very rarely true) to 5 (very often or always true).
Time Frame
Changes will be assessed pre-study; at one week, 3-month and 6-month post-intervention
Title
The number of re-hospitalization
Description
To collect information from both the case files and self-reporting
Time Frame
It will be measured 6-month post-intervention
Title
The length of re-hospitalization
Description
To collect information from both the case files and self-reporting
Time Frame
It will be measured 6-month post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thanos Karatzias
Organizational Affiliation
Edinburgh Napier University
Official's Role
Study Director
Facility Information:
Facility Name
The Fourth People's Hospital
City
Chengdu
Country
China
Facility Name
The Society of Rehabilitation and Crime Prevention
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All IPD that underlie results in a publication
IPD Sharing Time Frame
3-months after publication
IPD Sharing Access Criteria
Request by sending email

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Mindfulness Intervention for People With Psychosis

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