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

Primary Purpose

Psychotic Disorders, Schizophrenia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mindfulness Ambassador Council for Early Psychosis (MAC-EP)
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychotic Disorders focused on measuring Mindfulness, Group Therapy

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    Group-A - Immediate Intervention

    Group-B - Delayed Intervention

    Arm Description

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

    3 month treatment as usual waitlist followed by Mindfulness Ambassador Council for Early Psychosis (MAC-EP).

    Outcomes

    Primary Outcome Measures

    The Scale for Assessment of Positive Symptoms (SAPS)
    The Scale for Assessment of Negative Symptoms (SANS)
    The Profile of Mood States - Short Form (POMS)
    The Social Functioning Scale (SFS)
    Rosenberg Self-Esteem Scale (RSES)
    The Maryland Assessment of Recovery in People With Serious Mental Illness Scale (MARS)
    Kentucky Inventory of Mindfulness Skills (KIMS)
    Client Satisfaction Questionnaire - 8 Items (CSQ)
    Social Interaction Anxiety Scale (SIAS)
    Social Perception primary subtest of the Wechsler Adult Intelligence Scale (WAIS-SP)
    Theory of Mind Task (TOMT)
    Stroop Colour and Word Test (STROOP)
    Wechsler Digit Span Subtest (WDS)
    Controlled Oral Word Association Task (COWAT)
    Digit Symbol Coding Task (DSCT)
    Hopkins Verbal Learning Task Revised (HVLT)
    Health Care Utilization Records Pre-Intervention
    Qualitative Focus-group
    Health Care Utilization Records Post-Intervention

    Secondary Outcome Measures

    Full Information

    First Posted
    January 12, 2015
    Last Updated
    September 7, 2017
    Sponsor
    Lawson Health Research Institute
    Collaborators
    University of Western Ontario, Canada, London Health Sciences Centre, Mindfulness Without Borders
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02342210
    Brief Title
    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

    2. Study Status

    Record Verification Date
    September 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2015 (undefined)
    Primary Completion Date
    April 2016 (Actual)
    Study Completion Date
    April 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Lawson Health Research Institute
    Collaborators
    University of Western Ontario, Canada, London Health Sciences Centre, Mindfulness Without Borders

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Psychotic Disorders, Schizophrenia
    Keywords
    Mindfulness, Group Therapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    21 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group-A - Immediate Intervention
    Arm Type
    Other
    Arm Description
    Immediate Mindfulness Ambassador Council for Early Psychosis (MAC-EP)
    Arm Title
    Group-B - Delayed Intervention
    Arm Type
    Other
    Arm Description
    3 month treatment as usual waitlist followed by Mindfulness Ambassador Council for Early Psychosis (MAC-EP).
    Intervention Type
    Behavioral
    Intervention Name(s)
    Mindfulness Ambassador Council for Early Psychosis (MAC-EP)
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    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
    Title
    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
    Title
    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
    Title
    The Social Functioning Scale (SFS)
    Time Frame
    Baseline, Change from Baseline in SFS at 3 months, change from baseline in SFS at 6 months
    Title
    Rosenberg Self-Esteem Scale (RSES)
    Time Frame
    Baseline, Change from Baseline in RSES at 3 months, change from baseline in RSES at 6 months
    Title
    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
    Title
    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
    Title
    Client Satisfaction Questionnaire - 8 Items (CSQ)
    Time Frame
    Immediately Post-Intervention
    Title
    Social Interaction Anxiety Scale (SIAS)
    Time Frame
    Baseline, Change from Baseline in SIAS at 3 months, change from baseline in SIAS at 6 months
    Title
    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
    Title
    Theory of Mind Task (TOMT)
    Time Frame
    Baseline, Change from Baseline in TOMT at 3 months, change from baseline in TOMT at 6 months
    Title
    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
    Title
    Wechsler Digit Span Subtest (WDS)
    Time Frame
    Baseline, Change from Baseline in WDS at 3 months, change from baseline in WDS at 6 months
    Title
    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
    Title
    Digit Symbol Coding Task (DSCT)
    Time Frame
    Baseline, Change from Baseline in DSCT at 3 months, change from baseline in DSCT at 6 months
    Title
    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
    Title
    Health Care Utilization Records Pre-Intervention
    Time Frame
    Utilization during the 6 months prior to the mindfulness intervention
    Title
    Qualitative Focus-group
    Time Frame
    Immediately Post-Intervention
    Title
    Health Care Utilization Records Post-Intervention
    Time Frame
    Utilization during the 6 months following the mindfulness intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    30 Years
    Accepts Healthy Volunteers
    No
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Arlene MacDougall, M.Sc., M.D.
    Organizational Affiliation
    University of Western Ontario/London Health Sciences Centre
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    21976710
    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.
    Results Reference
    background
    PubMed Identifier
    9764127
    Citation
    Birchwood M, Todd P, Jackson C. Early intervention in psychosis. The critical period hypothesis. Br J Psychiatry Suppl. 1998;172(33):53-9.
    Results Reference
    background
    PubMed Identifier
    17099070
    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.
    Results Reference
    background
    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.
    Results Reference
    background
    PubMed Identifier
    23796855
    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.
    Results Reference
    background
    PubMed Identifier
    21549566
    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.
    Results Reference
    background
    PubMed Identifier
    23616779
    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.
    Results Reference
    background
    PubMed Identifier
    24220133
    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.
    Results Reference
    background
    PubMed Identifier
    25329321
    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.
    Results Reference
    background
    PubMed Identifier
    15819448
    Citation
    Wenk-Sormaz H. Meditation can reduce habitual responding. Altern Ther Health Med. 2005 Mar-Apr;11(2):42-58.
    Results Reference
    background
    Citation
    Zeidan F, Faust M. The efffects of brief mindful training on cognitive control. In Southeastern psychological association conference, Charlotte, NC, 2008.
    Results Reference
    background
    PubMed Identifier
    20363650
    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.
    Results Reference
    background
    Links:
    URL
    http://www.nimh.nih.gov/health/topics/schizophrenia/raise/nimh-white-paper-csc-for-fep_147096.pdf
    Description
    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).
    URL
    http://www.mwb.org
    Description
    Mindfulness Without Borders

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