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Completed

NCT Number: NCT03501862

Mindfulness Intervention for People With Psychosis

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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Key information

Conditions

Recent-Onset Psychosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Fourth People's Hospital, Chengdu, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Psychoeducation (psychosis)

Behavioral

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

Primary outcomes

  1. 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

  1. The Emotion Regulation Questionnaire (ERQ)

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

    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).

  2. The WHOQOL-100

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

    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.

  3. Positive and Negative Syndrome Scale (PANSS)

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

    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).

  4. Acceptance and Action Scale (AAQII)

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

    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).

  5. Five Facet Mindfulness Questionnaire (FFMQ)

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

    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).

  6. The number of re-hospitalization

    Time frame: It will be measured 6-month post-intervention

    To collect information from both the case files and self-reporting

  7. The length of re-hospitalization

    Time frame: It will be measured 6-month post-intervention

    To collect information from both the case files and self-reporting

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Collaborators

  • Edinburgh Napier University

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Apr 18, 2018
Registry last updated
Sep 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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