Overview

This trial is active, not recruiting.

Conditions psychotic disorders, schizophrenia
Treatment mindfulness ambassador council for early psychosis (mac-ep)
Sponsor Lawson Health Research Institute
Collaborator University of Western Ontario, Canada
Start date May 2015
End date April 2016
Trial size 30 participants
Trial identifier NCT02342210, 106127

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Other)
Immediate Mindfulness Ambassador Council for Early Psychosis (MAC-EP)
mindfulness ambassador council for early psychosis (mac-ep)
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.
(Other)
3 month treatment as usual waitlist followed by Mindfulness Ambassador Council for Early Psychosis (MAC-EP).
mindfulness ambassador council for early psychosis (mac-ep)
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 Outcomes

Measure
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
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
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
The Social Functioning Scale (SFS)
time frame: Baseline, Change from Baseline in SFS at 3 months, change from baseline in SFS at 6 months
Rosenberg Self-Esteem Scale (RSES)
time frame: 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)
time frame: Baseline, Change from Baseline in MARS at 3 months, change from baseline in MARS at 6 months
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
Client Satisfaction Questionnaire - 8 Items (CSQ)
time frame: Immediately Post-Intervention
Social Interaction Anxiety Scale (SIAS)
time frame: 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)
time frame: Baseline, Change from Baseline in WAIS-SP at 3 months, change from baseline in WAIS-SP at 6 months
Theory of Mind Task (TOMT)
time frame: Baseline, Change from Baseline in TOMT at 3 months, change from baseline in TOMT at 6 months
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
Wechsler Digit Span Subtest (WDS)
time frame: Baseline, Change from Baseline in WDS at 3 months, change from baseline in WDS at 6 months
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
Digit Symbol Coding Task (DSCT)
time frame: Baseline, Change from Baseline in DSCT at 3 months, change from baseline in DSCT at 6 months
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
Health Care Utilization Records Pre-Intervention
time frame: Utilization during the 6 months prior to the mindfulness intervention
Qualitative Focus-group
time frame: Immediately Post-Intervention
Health Care Utilization Records Post-Intervention
time frame: Utilization during the 6 months following the mindfulness intervention

Eligibility Criteria

Male or female participants from 18 years up to 30 years old.

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.

Additional Information

Official title Mindfulness Group-based Intervention for Early Psychosis: A Pilot Study
Principal investigator Arlene MacDougall, M.Sc., M.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Lawson Health Research Institute.