Mindfulness Intervention for People With Psychosis

Recent-onset Psychosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03501862
• Other study ID #: HSEARS20170811001
• Status: Completed
• Phase: N/A
• Start date: January 15, 2017
• Est. completion date: July 31, 2021

Study information

• Verified date: September 2021
• Source: The Hong Kong Polytechnic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: July 31, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mental Disorders
• Psychotic Disorders
• Recent-onset Psychosis

Intervention

Behavioral:
• Mindfulness-based cognitive therapy (psychosis)
A small group intervention is based on a structured and validated protocol that will include mindfulness practice, cognitive skills
• Psychoeducation (psychosis)
A small group intervention will be focusing on understanding of psychosis, treatment, relapse prevention and useful information and resources.

Locations

Country	Name	City	State
China	The Fourth People's Hospital	Chengdu
Hong Kong	The Society of Rehabilitation and Crime Prevention	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University	Edinburgh Napier University

Countries where clinical trial is conducted

China,  Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Changes will be assessed pre-study; at one week, 3-month and 6-month post-intervention
Secondary	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).	Changes will be assessed pre-study; at one week, 3-month and 6-month post-intervention
Secondary	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.	Changes will be assessed pre-study; at one week, 3-month and 6-month post-intervention
Secondary	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).	Changes will be assessed pre-study; at one week, 3-month and 6-month post-intervention
Secondary	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).	Changes will be assessed pre-study; at one week, 3-month and 6-month post-intervention
Secondary	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).	Changes will be assessed pre-study; at one week, 3-month and 6-month post-intervention
Secondary	The number of re-hospitalization	To collect information from both the case files and self-reporting	It will be measured 6-month post-intervention
Secondary	The length of re-hospitalization	To collect information from both the case files and self-reporting	It will be measured 6-month post-intervention