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Mindfulness Intervention for People With Psychosis

T

The Hong Kong Polytechnic University

Status

Completed

Conditions

Recent-onset Psychosis

Treatments

Behavioral: Psychoeducation (psychosis)
Behavioral: Mindfulness-based cognitive therapy (psychosis)

Study type

Interventional

Funder types

Other

Identifiers

NCT03501862
HSEARS20170811001

Details and patient eligibility

About

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.

Full 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.

Enrollment

108 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

108 participants in 2 patient groups

Mindfulness-based intervention
Experimental group
Description:
Intervention: a twelve 1.5 weekly program on mindfulness-based cognitive therapy (psychosis)
Treatment:
Behavioral: Mindfulness-based cognitive therapy (psychosis)
Psychoeducation
Active Comparator group
Description:
Intervention: a twelve 1.5 hours weekly program on psychoeducation (psychosis)
Treatment:
Behavioral: Psychoeducation (psychosis)

Trial documents
1

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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