Psychotic DisordersNCT02342210
Mindfulness Group-based Intervention for Early Psychosis: A Pilot Study
A study testing Mindfulness Ambassador Council for Early Psychosis (MAC-EP) in people with Psychotic Disorders and Schizophrenia, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's.
Trial summary
Recent research has suggested that mindfulness-based interventions for psychosis may be effective in reducing the negative symptoms of schizophrenia (e.g., social withdrawal, lack of motivation) and the distress associated with psychotic symptoms (e.g., hearing voices) and could lead to improvements in functioning and… Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Psychotic Disorders, Schizophrenia
- What is being tested?
- Mindfulness Ambassador Council for Early Psychosis (MAC-EP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- No sites listed yet
- Study dates
- May 2015to Apr 2016
- 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 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants must currently be in treatment at the Prevention and Early Intervention Program for Psychosis (PEPP) for psychosis. In addition, participants must have been involved in the program for a period of less than 3 years, due to the focus of this study being on the treatment of early psychosis. Participants must be between the ages of 18 and 30 years old. Participants must be fluent in English, as determined by referring clinicians or researchers (in the case of advertisement referred participants) in order to meaningfully participate in the MAC intervention and complete the assessment tools.
Who cannot join
- Potential participants that show high levels of disorganized or disruptive behaviour (as determined by a cut off score of 4 or 5 on the Positive Formal Thought Disorder or Bizarre Behaviour items of the Scale for the Assessment of Positive Symptoms [SAPS]) such that they will not be able to meaningfully participate in the MAC intervention will be excluded from the study.
About this study
Recent research has suggested that mindfulness-based interventions for psychosis may be effective in reducing the negative symptoms of schizophrenia (e.g., social withdrawal, lack of motivation) and the distress associated with psychotic symptoms (e.g., hearing voices) and could lead to improvements in functioning and quality of life. However these findings are based on small studies that largely consist of patients with chronic illness. Little is yet known about the use of mindfulness interventions for young people recovering from their first episode of psychosis.
The purpose of this study is to determine whether the Mindfulness Ambassador Council (MAC), a 12-week facilitated group intervention promoting mindfulness skills and the development of emotional and social competencies, is an effective, feasible, and acceptable means of treating youth in the early stages of psychotic illnesses. Although the current study is hypothesis generating in nature, based on previous investigations of Mindfulness Based Interventions for psychoses (Chadwick, 2014), we are expecting that participating in the MAC intervention will result in improvements in clinical, cognitive, functional, and health service utilization parameters. Additionally, we expect that the MAC intervention will prove to be acceptable to participants and a feasible intervention for early psychotic disorders.
Read the detailed description
The purpose of this study is to determine whether the Mindfulness Ambassador Council (MAC), a 12-week facilitated group mindfulness based intervention specifically designed to promote mindfulness skills and the development of emotional and social competencies in youth, is an effective, feasible, and acceptable means of treating people in the early stages of psychotic illnesses.
We intend to randomly assign 30 patients being treated for psychotic illnesses in an early intervention program to an immediate treatment intervention or a delayed treatment intervention. Participants assigned to the immediate treatment intervention will receive the MAC intervention at the onset of the study whereas those assigned to the delay treatment intervention will receive the MAC intervention after approximately 3 months in a treatment as usual control group.
Participants will be evaluated at baseline, immediately post-intervention and at 3-month post-intervention on a number measures. MAC acceptability will be assessed through the Client Satisfaction Questionnaire and qualitative interviews, MAC feasibility will be assessed through recruitment, consent and completion rates, and MAC efficacy will be assessed with a number of clinical, social, cognitive, and mindfulness skill assessment tools as well as through changes in healthcare utilization before and after administration of the MAC intervention.
Although the current study is hypothesis generating in nature, based on previous findings of Mindfulness Based Interventions for psychoses, we are expecting that participation in the MAC intervention will result in improvements on clinical, cognitive, functional, and health service utilization parameters. Additionally, we expect that the MAC intervention will be acceptable to participants and a feasible intervention for early psychotic disorders.
- Conditions
- Psychotic Disorders, Schizophrenia
- Being tested
- Mindfulness Ambassador Council for Early Psychosis (MAC-EP)
- Keywords
- Mindfulness, Group Therapy
- Medical subject headings
- Psychotic Disorders, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Ambassador Council for Early Psychosis (MAC-EP)Behavioural
MAC is a 12-week facilitated group mindfulness intervention promoting the development of social-emotional competence in youth created by Mindfulness Without Borders (MWB; www.mwb.org). A meditative practice, mindfulness focuses one's awareness on the present, acknowledging and accepting without judging one's feelings, thoughts, or bodily sensations. Each session has a unique focus (e.g., paying attention, practicing gratitude) and consists of facilitated group learning, discussion and mindfulness skills practice. Home assignments to help reinforce specific lesson are also assigned. Although MAC has demonstrated acceptability, feasibility, and promising beneficial effects in schools, it has yet to be implemented and/or evaluated in a clinical population. Its youth-focus and emphasis on building social and emotional competencies through mindfulness, in addition to teaching core mindfulness skills make it a promising intervention for youth recovering from their first episode of psychosis.
| Study group | Role | What they receive |
|---|---|---|
| Group-A - Immediate Intervention | Other | Immediate Mindfulness Ambassador Council for Early Psychosis (MAC-EP) Receives: Behavioral: Mindfulness Ambassador Council for Early Psychosis (MAC-EP) |
| Group-B - Delayed Intervention | Other | 3 month treatment as usual waitlist followed by Mindfulness Ambassador Council for Early Psychosis (MAC-EP). Receives: Behavioral: Mindfulness Ambassador Council for Early Psychosis (MAC-EP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Scale for Assessment of Positive Symptoms (SAPS)
Measured: Baseline, Change from Baseline in SAPS at 3 months, change from baseline in SAPS at 6 months
The Scale for Assessment of Negative Symptoms (SANS)
Measured: Baseline, Change from Baseline in SANS at 3 months, change from baseline in SANS at 6 months
The Profile of Mood States - Short Form (POMS)
Measured: Baseline, Change from Baseline in POMS at 3 months, change from baseline in POMSat 6 months
The Social Functioning Scale (SFS)
Measured: Baseline, Change from Baseline in SFS at 3 months, change from baseline in SFS at 6 months
Rosenberg Self-Esteem Scale (RSES)
Measured: Baseline, Change from Baseline in RSES at 3 months, change from baseline in RSES at 6 months
The Maryland Assessment of Recovery in People With Serious Mental Illness Scale (MARS)
Measured: Baseline, Change from Baseline in MARS at 3 months, change from baseline in MARS at 6 months
Kentucky Inventory of Mindfulness Skills (KIMS)
Measured: Baseline, Change from Baseline in KIMS at 3 months, change from baseline in KIMS at 6 months
Client Satisfaction Questionnaire - 8 Items (CSQ)
Measured: Immediately Post-Intervention
Social Interaction Anxiety Scale (SIAS)
Measured: Baseline, Change from Baseline in SIAS at 3 months, change from baseline in SIAS at 6 months
Social Perception primary subtest of the Wechsler Adult Intelligence Scale (WAIS-SP)
Measured: Baseline, Change from Baseline in WAIS-SP at 3 months, change from baseline in WAIS-SP at 6 months
Theory of Mind Task (TOMT)
Measured: Baseline, Change from Baseline in TOMT at 3 months, change from baseline in TOMT at 6 months
Stroop Colour and Word Test (STROOP)
Measured: Baseline, Change from Baseline in STROOP at 3 months, change from baseline in STROOP at 6 months
Wechsler Digit Span Subtest (WDS)
Measured: Baseline, Change from Baseline in WDS at 3 months, change from baseline in WDS at 6 months
Controlled Oral Word Association Task (COWAT)
Measured: Baseline, Change from Baseline in COWAT at 3 months, change from baseline in COWAT at 6 months
Digit Symbol Coding Task (DSCT)
Measured: Baseline, Change from Baseline in DSCT at 3 months, change from baseline in DSCT at 6 months
Hopkins Verbal Learning Task Revised (HVLT)
Measured: Baseline, Change from Baseline in HVLT at 3 months, change from baseline in HVLT at 6 months
Health Care Utilization Records Pre-Intervention
Measured: Utilization during the 6 months prior to the mindfulness intervention
Qualitative Focus-group
Measured: Immediately Post-Intervention
Health Care Utilization Records Post-Intervention
Measured: Utilization during the 6 months following the mindfulness intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2015 (estimated)
- Study startMay 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Psychotic DisordersStudies of the same condition, open and under way.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- University of Western Ontario, Canada, London Health Sciences Centre, Mindfulness Without Borders
- Responsible party
- Principal investigator, Arlene MacDougall, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Arlene MacDougall, M.Sc., M.D., Principal investigator, University of Western Ontario/London Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02342210
- Sponsor's protocol ID
- 106127
- Status last verified
- Sep 2017
- First submitted
- 12 Jan 2015
- Last updated
- 11 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Bell MD, Corbera S, Johannesen JK, Fiszdon JM, Wexler BE. Social cognitive impairments and negative symptoms in schizophrenia: are there subtypes with distinct functional correlates? Schizophr Bull. 2013 Jan;39(1):186-96. doi: 10.1093/schbul/sbr125. Epub 2011 Oct 5.
PubMed 21976710Birchwood M, Todd P, Jackson C. Early intervention in psychosis. The critical period hypothesis. Br J Psychiatry Suppl. 1998;172(33):53-9.
PubMed 9764127Buchanan RW. Persistent negative symptoms in schizophrenia: an overview. Schizophr Bull. 2007 Jul;33(4):1013-22. doi: 10.1093/schbul/sbl057. Epub 2006 Nov 10.
PubMed 17099070Chambers R, Lo BCY, Allen NB. The impact of intensive mindfulness training on attentional control, cognitive style and affect. Cognitive Therapy & Research 32: 303-322, 2008.
Khoury B, Lecomte T, Fortin G, Masse M, Therien P, Bouchard V, Chapleau MA, Paquin K, Hofmann SG. Mindfulness-based therapy: a comprehensive meta-analysis. Clin Psychol Rev. 2013 Aug;33(6):763-71. doi: 10.1016/j.cpr.2013.05.005. Epub 2013 Jun 7.
PubMed 23796855Norman RM, Manchanda R, Malla AK, Windell D, Harricharan R, Northcott S. Symptom and functional outcomes for a 5 year early intervention program for psychoses. Schizophr Res. 2011 Jul;129(2-3):111-5. doi: 10.1016/j.schres.2011.04.006. Epub 2011 May 5.
PubMed 21549566Shonin E, Van Gordon W, Griffiths MD. Mindfulness-based interventions: towards mindful clinical integration. Front Psychol. 2013 Apr 18;4:194. doi: 10.3389/fpsyg.2013.00194. eCollection 2013. No abstract available.
PubMed 23616779Shonin E, Van Gordon W, Griffiths MD. Do mindfulness-based therapies have a role in the treatment of psychosis? Aust N Z J Psychiatry. 2014 Feb;48(2):124-7. doi: 10.1177/0004867413512688. Epub 2013 Nov 12. No abstract available.
PubMed 24220133Tan LB, Lo BC, Macrae CN. Brief mindfulness meditation improves mental state attribution and empathizing. PLoS One. 2014 Oct 17;9(10):e110510. doi: 10.1371/journal.pone.0110510. eCollection 2014.
PubMed 25329321Wenk-Sormaz H. Meditation can reduce habitual responding. Altern Ther Health Med. 2005 Mar-Apr;11(2):42-58.
PubMed 15819448Zeidan F, Faust M. The efffects of brief mindful training on cognitive control. In Southeastern psychological association conference, Charlotte, NC, 2008.
Zeidan F, Johnson SK, Diamond BJ, David Z, Goolkasian P. Mindfulness meditation improves cognition: evidence of brief mental training. Conscious Cogn. 2010 Jun;19(2):597-605. doi: 10.1016/j.concog.2010.03.014. Epub 2010 Apr 3.
PubMed 20363650
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness Group-based Intervention for Early Psychosis: A Pilot Study
- ClinicalTrials.gov ID
- NCT02342210
- Acronym / sponsor ID
- 106127
- Conditions
- Psychotic Disorders, Schizophrenia
- Keywords
- Mindfulness, Group Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- University of Western Ontario, Canada, London Health Sciences Centre, Mindfulness Without Borders
- Study start
- May 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 19 Jan 2015 (estimated)
- 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.
Recent research has suggested that mindfulness-based interventions for psychosis may be effective in reducing the negative symptoms of schizophrenia (e.g., social withdrawal, lack of motivation) and the distress associated with psychotic symptoms (e.g., hearing voices) and could lead to improvements in functioning and quality of life. However these findings are based on small studies that largely consist of patients with chronic illness. Little is yet known about the use of mindfulness interventions for young people recovering from their first episode of psychosis.
The purpose of this study is to determine whether the Mindfulness Ambassador Council (MAC), a 12-week facilitated group intervention promoting mindfulness skills and the development of emotional and social competencies, is an effective, feasible, and acceptable means of treating youth in the early stages of psychotic illnesses. Although the current study is hypothesis generating in nature, based on previous investigations of Mindfulness Based Interventions for psychoses (Chadwick, 2014), we are expecting that participating in the MAC intervention will result in improvements in clinical, cognitive, functional, and health service utilization parameters. Additionally, we expect that the MAC intervention will prove to be acceptable to participants and a feasible intervention for early psychotic disorders.
Detailed description
The purpose of this study is to determine whether the Mindfulness Ambassador Council (MAC), a 12-week facilitated group mindfulness based intervention specifically designed to promote mindfulness skills and the development of emotional and social competencies in youth, is an effective, feasible, and acceptable means of treating people in the early stages of psychotic illnesses.
We intend to randomly assign 30 patients being treated for psychotic illnesses in an early intervention program to an immediate treatment intervention or a delayed treatment intervention. Participants assigned to the immediate treatment intervention will receive the MAC intervention at the onset of the study whereas those assigned to the delay treatment intervention will receive the MAC intervention after approximately 3 months in a treatment as usual control group.
Participants will be evaluated at baseline, immediately post-intervention and at 3-month post-intervention on a number measures. MAC acceptability will be assessed through the Client Satisfaction Questionnaire and qualitative interviews, MAC feasibility will be assessed through recruitment, consent and completion rates, and MAC efficacy will be assessed with a number of clinical, social, cognitive, and mindfulness skill assessment tools as well as through changes in healthcare utilization before and after administration of the MAC intervention.
Although the current study is hypothesis generating in nature, based on previous findings of Mindfulness Based Interventions for psychoses, we are expecting that participation in the MAC intervention will result in improvements on clinical, cognitive, functional, and health service utilization parameters. Additionally, we expect that the MAC intervention will be acceptable to participants and a feasible intervention for early psychotic disorders.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group-A - Immediate Intervention | Other | Behavioral: Mindfulness Ambassador Council for Early Psychosis (MAC-EP)Immediate Mindfulness Ambassador Council for Early Psychosis (MAC-EP) |
| Group-B - Delayed Intervention | Other | Behavioral: Mindfulness Ambassador Council for Early Psychosis (MAC-EP)3 month treatment as usual waitlist followed by Mindfulness Ambassador Council for Early Psychosis (MAC-EP). |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Participants must currently be in treatment at the Prevention and Early Intervention Program for Psychosis (PEPP) for psychosis. In addition, participants must have been involved in the program for a period of less than 3 years, due to the focus of this study being on the treatment of early psychosis. Participants must be between the ages of 18 and 30 years old. Participants must be fluent in English, as determined by referring clinicians or researchers (in the case of advertisement referred participants) in order to meaningfully participate in the MAC intervention and complete the assessment tools.
Key exclusion criteria (1 listed)
- Potential participants that show high levels of disorganized or disruptive behaviour (as determined by a cut off score of 4 or 5 on the Positive Formal Thought Disorder or Bizarre Behaviour items of the Scale for the Assessment of Positive Symptoms [SAPS]) such that they will not be able to meaningfully participate in the MAC intervention will be excluded from the study.
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 Ambassador Council for Early Psychosis (MAC-EP)MAC is a 12-week facilitated group mindfulness intervention promoting the development of social-emotional competence in youth created by Mindfulness Without Borders (MWB; www.mwb.org). A meditative practice, mindfulness focuses one's awareness on the present, acknowledging and accepting without judging one's feelings, thoughts, or bodily sensations. Each session has a unique focus (e.g., paying attention, practicing gratitude) and consists of facilitated group learning, discussion and mindfulness skills practice. Home assignments to help reinforce specific lesson are also assigned. Although MAC has demonstrated acceptability, feasibility, and promising beneficial effects in schools, it has yet to be implemented and/or evaluated in a clinical population. Its youth-focus and emphasis on building social and emotional competencies through mindfulness, in addition to teaching core mindfulness skills make it a promising intervention for youth recovering from their first episode of psychosis. | Behavioural | Group-A - Immediate Intervention, Group-B - Delayed Intervention |
Primary outcome
The Scale for Assessment of Positive Symptoms (SAPS)
Time frame: Baseline, Change from Baseline in SAPS at 3 months, change from baseline in SAPS at 6 months
The Scale for Assessment of Negative Symptoms (SANS)
Time frame: Baseline, Change from Baseline in SANS at 3 months, change from baseline in SANS at 6 months
The Profile of Mood States - Short Form (POMS)
Time frame: Baseline, Change from Baseline in POMS at 3 months, change from baseline in POMSat 6 months
The Social Functioning Scale (SFS)
Time frame: Baseline, Change from Baseline in SFS at 3 months, change from baseline in SFS at 6 months
Rosenberg Self-Esteem Scale (RSES)
Time frame: Baseline, Change from Baseline in RSES at 3 months, change from baseline in RSES at 6 months
The Maryland Assessment of Recovery in People With Serious Mental Illness Scale (MARS)
Time frame: Baseline, Change from Baseline in MARS at 3 months, change from baseline in MARS at 6 months
Kentucky Inventory of Mindfulness Skills (KIMS)
Time frame: Baseline, Change from Baseline in KIMS at 3 months, change from baseline in KIMS at 6 months
Client Satisfaction Questionnaire - 8 Items (CSQ)
Time frame: Immediately Post-Intervention
Social Interaction Anxiety Scale (SIAS)
Time frame: Baseline, Change from Baseline in SIAS at 3 months, change from baseline in SIAS at 6 months
Social Perception primary subtest of the Wechsler Adult Intelligence Scale (WAIS-SP)
Time frame: Baseline, Change from Baseline in WAIS-SP at 3 months, change from baseline in WAIS-SP at 6 months
Theory of Mind Task (TOMT)
Time frame: Baseline, Change from Baseline in TOMT at 3 months, change from baseline in TOMT at 6 months
Stroop Colour and Word Test (STROOP)
Time frame: Baseline, Change from Baseline in STROOP at 3 months, change from baseline in STROOP at 6 months
Wechsler Digit Span Subtest (WDS)
Time frame: Baseline, Change from Baseline in WDS at 3 months, change from baseline in WDS at 6 months
Controlled Oral Word Association Task (COWAT)
Time frame: Baseline, Change from Baseline in COWAT at 3 months, change from baseline in COWAT at 6 months
Digit Symbol Coding Task (DSCT)
Time frame: Baseline, Change from Baseline in DSCT at 3 months, change from baseline in DSCT at 6 months
Hopkins Verbal Learning Task Revised (HVLT)
Time frame: Baseline, Change from Baseline in HVLT at 3 months, change from baseline in HVLT at 6 months
Health Care Utilization Records Pre-Intervention
Time frame: Utilization during the 6 months prior to the mindfulness intervention
Qualitative Focus-group
Time frame: Immediately Post-Intervention
Health Care Utilization Records Post-Intervention
Time frame: Utilization during the 6 months following the mindfulness 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 11 Sep 2017.
- Background: PubMed 21976710Bell MD, Corbera S, Johannesen JK, Fiszdon JM, Wexler BE. Social cognitive impairments and negative symptoms in schizophrenia: are there subtypes with distinct functional correlates? Schizophr Bull. 2013 Jan;39(1):186-96. doi: 10.1093/schbul/sbr125. Epub 2011 Oct 5.
- Background: PubMed 9764127Birchwood M, Todd P, Jackson C. Early intervention in psychosis. The critical period hypothesis. Br J Psychiatry Suppl. 1998;172(33):53-9.
- Background: PubMed 17099070Buchanan RW. Persistent negative symptoms in schizophrenia: an overview. Schizophr Bull. 2007 Jul;33(4):1013-22. doi: 10.1093/schbul/sbl057. Epub 2006 Nov 10.
- BackgroundChambers R, Lo BCY, Allen NB. The impact of intensive mindfulness training on attentional control, cognitive style and affect. Cognitive Therapy & Research 32: 303-322, 2008.
- Background: PubMed 23796855Khoury B, Lecomte T, Fortin G, Masse M, Therien P, Bouchard V, Chapleau MA, Paquin K, Hofmann SG. Mindfulness-based therapy: a comprehensive meta-analysis. Clin Psychol Rev. 2013 Aug;33(6):763-71. doi: 10.1016/j.cpr.2013.05.005. Epub 2013 Jun 7.
- Background: PubMed 21549566Norman RM, Manchanda R, Malla AK, Windell D, Harricharan R, Northcott S. Symptom and functional outcomes for a 5 year early intervention program for psychoses. Schizophr Res. 2011 Jul;129(2-3):111-5. doi: 10.1016/j.schres.2011.04.006. Epub 2011 May 5.
- Background: PubMed 23616779Shonin E, Van Gordon W, Griffiths MD. Mindfulness-based interventions: towards mindful clinical integration. Front Psychol. 2013 Apr 18;4:194. doi: 10.3389/fpsyg.2013.00194. eCollection 2013. No abstract available.
- Background: PubMed 24220133Shonin E, Van Gordon W, Griffiths MD. Do mindfulness-based therapies have a role in the treatment of psychosis? Aust N Z J Psychiatry. 2014 Feb;48(2):124-7. doi: 10.1177/0004867413512688. Epub 2013 Nov 12. No abstract available.
- Background: PubMed 25329321Tan LB, Lo BC, Macrae CN. Brief mindfulness meditation improves mental state attribution and empathizing. PLoS One. 2014 Oct 17;9(10):e110510. doi: 10.1371/journal.pone.0110510. eCollection 2014.
- Background: PubMed 15819448Wenk-Sormaz H. Meditation can reduce habitual responding. Altern Ther Health Med. 2005 Mar-Apr;11(2):42-58.
- BackgroundZeidan F, Faust M. The efffects of brief mindful training on cognitive control. In Southeastern psychological association conference, Charlotte, NC, 2008.
- Background: PubMed 20363650Zeidan F, Johnson SK, Diamond BJ, David Z, Goolkasian P. Mindfulness meditation improves cognition: evidence of brief mental training. Conscious Cogn. 2010 Jun;19(2):597-605. doi: 10.1016/j.concog.2010.03.014. Epub 2010 Apr 3.
- Heinssen, R.K., Goldstein, A.B., \& Azrin, S.T. (2014). Evidence-Based Treatments for First Episode Psychosis: Components of Coordinated Specialty Care. Recovery After An Initial Schizophrenia Episode (RA1SE).Link provided by the sponsor.
- Mindfulness Without BordersLink provided by the sponsor.
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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.
Arlene MacDougall, M.Sc., M.D. principal investigator
University of Western Ontario/London Health Sciences Centre
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Ambassador Council for Early Psychosis (MAC-EP) in people with Psychotic Disorders and Schizophrenia, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's.
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 1 inclusion and 1 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 11 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
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 Scale for Assessment of Positive Symptoms (SAPS) (time frame: Baseline, Change from Baseline in SAPS at 3 months, change from baseline in SAPS at 6 months). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02342210, which also lists 12 linked publications.
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 11 Sep 2017.