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Clinical Trials/NCT03501862
NCT03501862
Completed
Not Applicable

Mindfulness-based Interventions for People With Recent-onset Psychosis: A Randomized Controlled Trial

The Hong Kong Polytechnic University2 sites in 2 countries108 target enrollmentJanuary 15, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Recent-onset Psychosis
Sponsor
The Hong Kong Polytechnic University
Enrollment
108
Locations
2
Primary Endpoint
The Depression Anxiety Stress Scale - short form (DASS-21)
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 15, 2017
End Date
July 31, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

YIP Lai King

Senior Clinical Associate

The Hong Kong Polytechnic University

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

Outcomes

Primary Outcomes

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

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

). 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 Outcomes

  • Positive and Negative Syndrome Scale (PANSS)(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)
  • The number of re-hospitalization(It will be measured 6-month post-intervention)
  • The Emotion Regulation Questionnaire (ERQ)(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)
  • The length of re-hospitalization(It will be measured 6-month post-intervention)
  • The WHOQOL-100(Changes will be assessed pre-study; at one week, 3-month and 6-month post-intervention)

Study Sites (2)

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