Clinical trial NCT02342210: Mindfulness Group-based Intervention for Early Psychosis: A Pilot Study
Official title: Mindfulness Group-based Intervention for Early Psychosis: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychotic Disorders
Schizophrenia
Keywords: Mindfulness
Group Therapy
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: University of Western Ontario, Canada
name: London Health Sciences Centre
name: Mindfulness Without Borders
First posted: 2015-01-19
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The Scale for Assessment of Positive Symptoms (SAPS)
timeFrame: Baseline, Change from Baseline in SAPS at 3 months, change from baseline in SAPS at 6 months
measure: The Scale for Assessment of Negative Symptoms (SANS)
timeFrame: Baseline, Change from Baseline in SANS at 3 months, change from baseline in SANS at 6 months
measure: The Profile of Mood States - Short Form (POMS)
timeFrame: Baseline, Change from Baseline in POMS at 3 months, change from baseline in POMSat 6 months
measure: The Social Functioning Scale (SFS)
timeFrame: Baseline, Change from Baseline in SFS at 3 months, change from baseline in SFS at 6 months
measure: Rosenberg Self-Esteem Scale (RSES)
timeFrame: Baseline, Change from Baseline in RSES at 3 months, change from baseline in RSES at 6 months
measure: The Maryland Assessment of Recovery in People With Serious Mental Illness Scale (MARS)
timeFrame: Baseline, Change from Baseline in MARS at 3 months, change from baseline in MARS at 6 months
measure: Kentucky Inventory of Mindfulness Skills (KIMS)
timeFrame: Baseline, Change from Baseline in KIMS at 3 months, change from baseline in KIMS at 6 months
measure: Client Satisfaction Questionnaire - 8 Items (CSQ)
timeFrame: Immediately Post-Intervention
measure: Social Interaction Anxiety Scale (SIAS)
timeFrame: Baseline, Change from Baseline in SIAS at 3 months, change from baseline in SIAS at 6 months
measure: Social Perception primary subtest of the Wechsler Adult Intelligence Scale (WAIS-SP)
timeFrame: Baseline, Change from Baseline in WAIS-SP at 3 months, change from baseline in WAIS-SP at 6 months
measure: Theory of Mind Task (TOMT)
timeFrame: Baseline, Change from Baseline in TOMT at 3 months, change from baseline in TOMT at 6 months
measure: Stroop Colour and Word Test (STROOP)
timeFrame: Baseline, Change from Baseline in STROOP at 3 months, change from baseline in STROOP at 6 months
measure: Wechsler Digit Span Subtest (WDS)
timeFrame: Baseline, Change from Baseline in WDS at 3 months, change from baseline in WDS at 6 months
measure: Controlled Oral Word Association Task (COWAT)
timeFrame: Baseline, Change from Baseline in COWAT at 3 months, change from baseline in COWAT at 6 months
measure: Digit Symbol Coding Task (DSCT)
timeFrame: Baseline, Change from Baseline in DSCT at 3 months, change from baseline in DSCT at 6 months
measure: Hopkins Verbal Learning Task Revised (HVLT)
timeFrame: Baseline, Change from Baseline in HVLT at 3 months, change from baseline in HVLT at 6 months
measure: Health Care Utilization Records Pre-Intervention
timeFrame: Utilization during the 6 months prior to the mindfulness intervention
measure: Qualitative Focus-group
timeFrame: Immediately Post-Intervention
measure: Health Care Utilization Records Post-Intervention
timeFrame: Utilization during the 6 months following the mindfulness intervention
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Western Ontario/London Health Sciences Centre
name: Arlene MacDougall, M.Sc., M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Birchwood M, Todd P, Jackson C. Early intervention in psychosis. The critical period hypothesis. Br J Psychiatry Suppl. 1998;172(33):53-9.
citation: Buchanan 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.
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.
citation: 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.
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.
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. No abstract available.
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. No abstract available.
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.
citation: Wenk-Sormaz H. Meditation can reduce habitual responding. Altern Ther Health Med. 2005 Mar-Apr;11(2):42-58.
citation: Zeidan F, Faust M. The efffects of brief mindful training on cognitive control. In Southeastern psychological association conference, Charlotte, NC, 2008.
citation: 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.