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
About this trial
This is an interventional treatment trial for Psychotic Disorders focused on measuring Mindfulness, Group Therapy
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.
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
NCT ID
NCT02342210
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
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
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Results Reference
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Citation
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PubMed Identifier
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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.
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Citation
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PubMed Identifier
23796855
Citation
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21549566
Citation
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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
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PubMed Identifier
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Citation
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PubMed Identifier
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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.
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Citation
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Zeidan F, Faust M. The efffects of brief mindful training on cognitive control. In Southeastern psychological association conference, Charlotte, NC, 2008.
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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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Mindfulness Group-based Intervention for Early Psychosis: A Pilot Study
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