Recent-onset PsychosisNCT03501862
Mindfulness Intervention for People With Psychosis
A study testing Mindfulness-based cognitive therapy (psychosis) and Psychoeducation (psychosis) in people with Recent-onset Psychosis, run by The Hong Kong Polytechnic University at 2 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recent-onset Psychosis
- What is being tested?
- Mindfulness-based cognitive therapy (psychosis) and Psychoeducation (psychosis)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 15 Jan 2017to 31 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Hong Kong1 site
The Society of Rehabilitation and Crime Prevention
Hong Kong
About this study
Official title: Mindfulness-based Interventions for People With Recent-onset Psychosis: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Recent-onset Psychosis
- Being tested
- Mindfulness-based cognitive therapy (psychosis), Psychoeducation (psychosis)
- Keywords
- Mindfulness, Cognitive therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based cognitive therapy (psychosis)Behavioural
A small group intervention is based on a structured and validated protocol that will include mindfulness practice, cognitive skills
Psychoeducation (psychosis)Behavioural
A small group intervention will be focusing on understanding of psychosis, treatment, relapse prevention and useful information and resources.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-based intervention | Experimental | Intervention: a twelve 1.5 weekly program on mindfulness-based cognitive therapy (psychosis) Receives: Behavioral: Mindfulness-based cognitive therapy (psychosis) |
| Psychoeducation | Active comparator | Intervention: a twelve 1.5 hours weekly program on psychoeducation (psychosis) Receives: Behavioral: Psychoeducation (psychosis) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Changes will be assessed pre-study; at one week, 3-month and 6-month post-intervention
Secondary outcomes (7)
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).
Measured: Changes will be assessed pre-study; at one week, 3-month and 6-month post-intervention
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.
Measured: Changes will be assessed pre-study; at one week, 3-month and 6-month post-intervention
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).
Measured: Changes will be assessed pre-study; at one week, 3-month and 6-month post-intervention
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).
Measured: Changes will be assessed pre-study; at one week, 3-month and 6-month post-intervention
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).
Measured: Changes will be assessed pre-study; at one week, 3-month and 6-month post-intervention
The number of re-hospitalization
To collect information from both the case files and self-reporting
Measured: It will be measured 6-month post-intervention
The length of re-hospitalization
To collect information from both the case files and self-reporting
Measured: It will be measured 6-month post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2018
- Study start15 Jan 2017
- Primary completion31 Jul 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recent-onset PsychosisStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- Edinburgh Napier University
- Responsible party
- Principal investigator, YIP Lai King, The Hong Kong Polytechnic University
- Investigators
- Thanos Karatzias, Study director, Edinburgh Napier University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03501862
- Sponsor's protocol ID
- HSEARS20170811001
- Status last verified
- Sep 2021
- First submitted
- 9 Mar 2018
- Last updated
- 27 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness-based Interventions for People With Recent-onset Psychosis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03501862
- Acronym / sponsor ID
- HSEARS20170811001
- Conditions
- Recent-onset Psychosis
- Keywords
- Mindfulness, Cognitive therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- Edinburgh Napier University
- Study start
- 15 Jan 2017 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 18 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-based intervention | Experimental | Behavioral: Mindfulness-based cognitive therapy (psychosis)Intervention: a twelve 1.5 weekly program on mindfulness-based cognitive therapy (psychosis) |
| Psychoeducation | Active comparator | Behavioral: Psychoeducation (psychosis)Intervention: a twelve 1.5 hours weekly program on psychoeducation (psychosis) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-based cognitive therapy (psychosis)A small group intervention is based on a structured and validated protocol that will include mindfulness practice, cognitive skills | Behavioural | Mindfulness-based intervention |
| Psychoeducation (psychosis)A small group intervention will be focusing on understanding of psychosis, treatment, relapse prevention and useful information and resources. | Behavioural | Psychoeducation |
Primary outcome
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).
7 secondary outcomes
The Emotion Regulation Questionnaire (ERQ)
Time frame: Changes will be assessed pre-study; at one week, 3-month and 6-month post-intervention
The WHOQOL-100
Time frame: Changes will be assessed pre-study; at one week, 3-month and 6-month post-intervention
Positive and Negative Syndrome Scale (PANSS)
Time frame: Changes will be assessed pre-study; at one week, 3-month and 6-month post-intervention
Acceptance and Action Scale (AAQII)
Time frame: Changes will be assessed pre-study; at one week, 3-month and 6-month post-intervention
Five Facet Mindfulness Questionnaire (FFMQ)
Time frame: Changes will be assessed pre-study; at one week, 3-month and 6-month post-intervention
The number of re-hospitalization
Time frame: It will be measured 6-month post-intervention
The length of re-hospitalization
Time frame: It will be measured 6-month post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2021.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication
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Effects of a Peer-facilitated, Acceptance-based Self-learning for Illness Management (PASIM) Program
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Treating Schizophrenia by Correcting Abnormal Brain Development
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tDCS for Cognitive Impairment Associated With Recent-onset Schizophrenia
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thanos Karatzias study director
Edinburgh Napier University
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-based cognitive therapy (psychosis) and Psychoeducation (psychosis) in people with Recent-onset Psychosis, run by The Hong Kong Polytechnic University at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China, Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2021.