Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Edinburgh Napier University | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness-based intervention | Experimental | Intervention: a twelve 1.5 weekly program on mindfulness-based cognitive therapy (psychosis) |
|
| Psychoeducation | Active Comparator | Intervention: a twelve 1.5 hours weekly program on psychoeducation (psychosis) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Thanos Karatzias | Edinburgh Napier University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Fourth People's Hospital | Chengdu | China | ||||
| The Society of Rehabilitation and Crime Prevention |
All IPD that underlie results in a publication
3-months after publication
Request by sending email
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 5, 2017 | Apr 10, 2018 | SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D000099025 | Mindfulness-Based Cognitive Therapy |
| ID | Term |
|---|---|
| D064866 | Mindfulness |
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
Not provided
Not provided
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).
Not provided
Not provided
Assignment to the study groups will be made independently of staff involved in the recruitment and management of participants in the study.
| Psychoeducation (psychosis) | Behavioral | A small group intervention will be focusing on understanding of psychosis, treatment, relapse prevention and useful information and resources. |
|
| 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 |
| 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 |
| 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 |
| 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 |
| The number of re-hospitalization | To collect information from both the case files and self-reporting | It will be measured 6-month post-intervention |
| The length of re-hospitalization | To collect information from both the case files and self-reporting | It will be measured 6-month post-intervention |
| Hong Kong |
| Hong Kong |
| D004191 |
| Behavioral Disciplines and Activities |