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

Not Applicable

Completed

• Conditions: Psychotic Disorders; Schizophrenia
• Interventions: Behavioral: Mindfulness Ambassador Council for Early Psychosis (MAC-EP)

• Registration Number: NCT02342210
• Lead Sponsor: Lawson Health Research Institute

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2015-01-12
• Study First Submitted QC: 2015-01-14
• Study First Posted: 2015-01-19
• Study Start: 2015-05
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-07
• Last Update Posted: 2017-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group-B - Delayed Intervention	Mindfulness Ambassador Council for Early Psychosis (MAC-EP)	3 month treatment as usual waitlist followed by Mindfulness Ambassador Council for Early Psychosis (MAC-EP).
Group-A - Immediate Intervention	Mindfulness Ambassador Council for Early Psychosis (MAC-EP)	Immediate Mindfulness Ambassador Council for Early Psychosis (MAC-EP)

Primary Outcome Measures

Name	Time	Method
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 Social Functioning Scale (SFS)	Baseline, Change from Baseline in SFS at 3 months, change from baseline in SFS 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
Controlled Oral Word Association Task (COWAT)	Baseline, Change from Baseline in COWAT at 3 months, change from baseline in COWAT 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
Health Care Utilization Records Post-Intervention	Utilization during the 6 months following the mindfulness intervention
Rosenberg Self-Esteem Scale (RSES)	Baseline, Change from Baseline in RSES at 3 months, change from baseline in RSES 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
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
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 Profile of Mood States - Short Form (POMS)	Baseline, Change from Baseline in POMS at 3 months, change from baseline in POMSat 6 months
Health Care Utilization Records Pre-Intervention	Utilization during the 6 months prior to the mindfulness intervention
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
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
Qualitative Focus-group	Immediately Post-Intervention