Schizophrenia Clinical Trial
Official title:
Mindfulness Group-based Intervention for Early Psychosis: A Pilot Study
Verified date | September 2017 |
Source | Lawson Health Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 21 |
Est. completion date | April 2016 |
Est. primary completion date | April 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 30 Years |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
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Lawson Health Research Institute | London Health Sciences Centre, Mindfulness Without Borders, University of Western Ontario, Canada |
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. — View Citation
Birchwood M, Todd P, Jackson C. Early intervention in psychosis. The critical period hypothesis. Br J Psychiatry Suppl. 1998;172(33):53-9. Review. — View Citation
Buchanan RW. Persistent negative symptoms in schizophrenia: an overview. Schizophr Bull. 2007 Jul;33(4):1013-22. Epub 2006 Nov 10. Review. — View Citation
Chambers 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. — View Citation
Norman 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. — View Citation
Shonin 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. Review. — View Citation
Shonin 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. — View Citation
Tan 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. — View Citation
Wenk-Sormaz H. Meditation can reduce habitual responding. Altern Ther Health Med. 2005 Mar-Apr;11(2):42-58. — View Citation
Zeidan 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. — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The Scale for Assessment of Positive Symptoms (SAPS) | Baseline, Change from Baseline in SAPS at 3 months, change from baseline in SAPS at 6 months | ||
Primary | The Scale for Assessment of Negative Symptoms (SANS) | Baseline, Change from Baseline in SANS at 3 months, change from baseline in SANS at 6 months | ||
Primary | The Profile of Mood States - Short Form (POMS) | Baseline, Change from Baseline in POMS at 3 months, change from baseline in POMSat 6 months | ||
Primary | The Social Functioning Scale (SFS) | Baseline, Change from Baseline in SFS at 3 months, change from baseline in SFS at 6 months | ||
Primary | Rosenberg Self-Esteem Scale (RSES) | Baseline, Change from Baseline in RSES at 3 months, change from baseline in RSES at 6 months | ||
Primary | The Maryland Assessment of Recovery in People With Serious Mental Illness Scale (MARS) | Baseline, Change from Baseline in MARS at 3 months, change from baseline in MARS at 6 months | ||
Primary | Kentucky Inventory of Mindfulness Skills (KIMS) | Baseline, Change from Baseline in KIMS at 3 months, change from baseline in KIMS at 6 months | ||
Primary | Client Satisfaction Questionnaire - 8 Items (CSQ) | Immediately Post-Intervention | ||
Primary | Social Interaction Anxiety Scale (SIAS) | Baseline, Change from Baseline in SIAS at 3 months, change from baseline in SIAS at 6 months | ||
Primary | Social Perception primary subtest of the Wechsler Adult Intelligence Scale (WAIS-SP) | Baseline, Change from Baseline in WAIS-SP at 3 months, change from baseline in WAIS-SP at 6 months | ||
Primary | Theory of Mind Task (TOMT) | Baseline, Change from Baseline in TOMT at 3 months, change from baseline in TOMT at 6 months | ||
Primary | Stroop Colour and Word Test (STROOP) | Baseline, Change from Baseline in STROOP at 3 months, change from baseline in STROOP at 6 months | ||
Primary | Wechsler Digit Span Subtest (WDS) | Baseline, Change from Baseline in WDS at 3 months, change from baseline in WDS at 6 months | ||
Primary | Controlled Oral Word Association Task (COWAT) | Baseline, Change from Baseline in COWAT at 3 months, change from baseline in COWAT at 6 months | ||
Primary | Digit Symbol Coding Task (DSCT) | Baseline, Change from Baseline in DSCT at 3 months, change from baseline in DSCT at 6 months | ||
Primary | Hopkins Verbal Learning Task Revised (HVLT) | Baseline, Change from Baseline in HVLT at 3 months, change from baseline in HVLT at 6 months | ||
Primary | Health Care Utilization Records Pre-Intervention | Utilization during the 6 months prior to the mindfulness intervention | ||
Primary | Qualitative Focus-group | Immediately Post-Intervention | ||
Primary | Health Care Utilization Records Post-Intervention | Utilization during the 6 months following the mindfulness intervention |
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