Mindfulness Group-based Intervention for Early Psychosis: A Pilot Study

NCT02342210 | Completed

• 1 other identifier: 106127
• Study Type: interventional
• Target: 21
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Psychotic Disorders; Schizophrenia

Keywords

Mindfulness; Group Therapy

Outcome Measures

Primary Outcomes (19)

• 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

• 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

• The Profile of Mood States - Short Form (POMS)

  Baseline, Change from Baseline in POMS at 3 months, change from baseline in POMSat 6 months

• The Social Functioning Scale (SFS)

  Baseline, Change from Baseline in SFS at 3 months, change from baseline in SFS at 6 months

• Rosenberg Self-Esteem Scale (RSES)

  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)

  Baseline, Change from Baseline in MARS at 3 months, change from baseline in MARS at 6 months

• Kentucky Inventory of Mindfulness Skills (KIMS)

  Baseline, Change from Baseline in KIMS at 3 months, change from baseline in KIMS at 6 months

• Client Satisfaction Questionnaire - 8 Items (CSQ)

  Immediately Post-Intervention

• Social Interaction Anxiety Scale (SIAS)

  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)

  Baseline, Change from Baseline in WAIS-SP at 3 months, change from baseline in WAIS-SP at 6 months

• Theory of Mind Task (TOMT)

  Baseline, Change from Baseline in TOMT at 3 months, change from baseline in TOMT at 6 months

• Stroop Colour and Word Test (STROOP)

  Baseline, Change from Baseline in STROOP at 3 months, change from baseline in STROOP at 6 months

• Wechsler Digit Span Subtest (WDS)

  Baseline, Change from Baseline in WDS at 3 months, change from baseline in WDS at 6 months

• Controlled Oral Word Association Task (COWAT)

  Baseline, Change from Baseline in COWAT at 3 months, change from baseline in COWAT at 6 months

• Digit Symbol Coding Task (DSCT)

  Baseline, Change from Baseline in DSCT at 3 months, change from baseline in DSCT at 6 months

• Hopkins Verbal Learning Task Revised (HVLT)

  Baseline, Change from Baseline in HVLT at 3 months, change from baseline in HVLT at 6 months

• Health Care Utilization Records Pre-Intervention

  Utilization during the 6 months prior to the mindfulness intervention

• Qualitative Focus-group

  Immediately Post-Intervention

• Health Care Utilization Records Post-Intervention

  Utilization during the 6 months following the mindfulness intervention

Study Arms (2)

Group-A - Immediate Intervention

OTHER

Immediate Mindfulness Ambassador Council for Early Psychosis (MAC-EP)

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).

Behavioral: Mindfulness Ambassador Council for Early Psychosis (MAC-EP)

Interventions

Mindfulness Ambassador Council for Early Psychosis (MAC-EP) BEHAVIORAL

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.

Group-A - Immediate Intervention; Group-B - Delayed Intervention

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• University of Western Ontario, Canada: collaborator
• London Health Sciences Centre: collaborator
• Mindfulness Without Borders: collaborator

Related Publications (12)

• 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.

  PMID: 21976710 BACKGROUND

• Birchwood M, Todd P, Jackson C. Early intervention in psychosis. The critical period hypothesis. Br J Psychiatry Suppl. 1998;172(33):53-9.

  PMID: 9764127 BACKGROUND

• 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.

  PMID: 17099070 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 23796855 BACKGROUND

• 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.

  PMID: 21549566 BACKGROUND

• 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.

  PMID: 23616779 BACKGROUND

• 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.

  PMID: 24220133 BACKGROUND

• 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.

  PMID: 25329321 BACKGROUND

• Wenk-Sormaz H. Meditation can reduce habitual responding. Altern Ther Health Med. 2005 Mar-Apr;11(2):42-58.

  PMID: 15819448 BACKGROUND

• Zeidan F, Faust M. The efffects of brief mindful training on cognitive control. In Southeastern psychological association conference, Charlotte, NC, 2008.

  BACKGROUND

• 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.

  PMID: 20363650 BACKGROUND

Related Links

• 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).
• Mindfulness Without Borders

MeSH Terms

Conditions

Psychotic Disorders; Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Arlene MacDougall, M.Sc., M.D.

  University of Western Ontario/London Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 12, 2015
• First Posted: January 19, 2015
• Study Start: May 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: September 11, 2017

Record last verified: 2017-09