Clinical trial NCT03501862: Mindfulness Intervention for People With Psychosis
Official title: Mindfulness-based Interventions for People With Recent-onset Psychosis: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Recent-onset Psychosis
Keywords: Mindfulness
Cognitive therapy
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
Collaborators: name: Edinburgh Napier University
First posted: 2018-04-18
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The Depression Anxiety Stress Scale - short form (DASS-21)
timeFrame: Changes will be assessed pre-study; at one week, 3-month and 6-month post-intervention
Secondary outcomes:
measure: The Emotion Regulation Questionnaire (ERQ)
timeFrame: Changes will be assessed pre-study; at one week, 3-month and 6-month post-intervention
measure: The WHOQOL-100
timeFrame: Changes will be assessed pre-study; at one week, 3-month and 6-month post-intervention
measure: Positive and Negative Syndrome Scale (PANSS)
timeFrame: Changes will be assessed pre-study; at one week, 3-month and 6-month post-intervention
measure: Acceptance and Action Scale (AAQII)
timeFrame: Changes will be assessed pre-study; at one week, 3-month and 6-month post-intervention
measure: Five Facet Mindfulness Questionnaire (FFMQ)
timeFrame: Changes will be assessed pre-study; at one week, 3-month and 6-month post-intervention
measure: The number of re-hospitalization
timeFrame: It will be measured 6-month post-intervention
measure: The length of re-hospitalization
timeFrame: It will be measured 6-month post-intervention
Other outcomes:
Locations:
city: Chengdu
country: China
facility: The Fourth People's Hospital
city: Hong Kong
country: Hong Kong
facility: The Society of Rehabilitation and Crime Prevention
Study officials:
affiliation: Edinburgh Napier University
name: Thanos Karatzias
role: STUDY_DIRECTOR
References: