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Mindfulness Group-based Intervention for Early Psychosis

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ClinicalTrials.gov Identifier: NCT03143907
Recruitment Status : Recruiting
First Posted : May 8, 2017
Last Update Posted : June 20, 2018
Sponsor:
Collaborators:
University of Western Ontario, Canada
London Health Sciences Centre
Mindfulness Without Borders
Information provided by (Responsible Party):
Lawson Health Research Institute

Brief Summary:
Recent research has suggested that mindfulness-based interventions (MBI) 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. MBI research to date has primarily focused on studies of patients with chronic psychotic illness, yet relatively little is known about the use of MBIs for youth recovering from their first episode of psychosis. Results from recently published pilot studies appear promising in terms of the feasibility, acceptability, and potential clinical utility (e.g., improved psychological symptoms) of MBIs for the early psychosis population (Ashcroft et al., 2012; van der Valk et al., 2013; Khoury et al., 2015). The current project team has completed a pilot study at the Prevention and Early Intervention Program for Psychoses (PEPP) at London Health Sciences Centre (LHSC), wherein the "Mindfulness Ambassador Council" (MAC), a 12-week facilitated group intervention promoting mindfulness skills and the development of emotional and social competencies, was shown to be an effective, feasible, and acceptable means of treating youth in the early stages of psychotic illnesses. In follow up to the initial pilot study, the purpose of this study is to perform a multi-site Randomized Control Trial to determine the effectiveness of the MAC group intervention on reducing psychotic disorder symptomatology for transitional aged youth experiencing early psychosis. The main hypothesis, based on previous findings on the use of MBIs in psychotic disorders, including results from our initial pilot study at PEPP, is that people with early psychosis who participate in the MAC group intervention will experience improvement in mindfulness skills and affective symptoms compared to those receiving treatment as usual (TAU). Furthermore, we expect that people experiencing early psychosis who participate in MAC will have an improvement in their negative symptoms, quality of life, recovery (self-esteem, perceived recovery), perceived coping, assertiveness, social functioning, and cognitive skills, and a reduction in healthcare service utilization (e.g., emergency room visits, inpatient admissions/length of hospitalization).

Condition or disease Intervention/treatment Phase
Psychotic Disorders Schizophrenia Behavioral: Mindfulness Ambassador Council for Early Psychosis (MAC-EP) Not Applicable

Detailed Description:

The purpose of this multi-site RCT is to determine the effectiveness of the MAC group intervention on reducing psychotic disorder symptomatology (primary outcome) as well as promoting quality of life, critical skills for recovery and decreasing mental health service utilization (secondary outcomes) for transitional aged youth (16-25 years old) experiencing early psychosis. This study is being run at five southern Ontario Early Psychosis Intervention (EPI) sites with Prevention and Early Intervention Program for Psychoses (PEPP) at London Health Sciences Centre (LHSC) being the lead site. Three of the larger sites (located in London, Kitchener-Waterloo, and Hamilton Ontario) are following the RCT design, while the two smaller sites (located in Chatham-Kent and Sarnia, Ontario) are participating in a pre-post design.

For the three RCT sites we aim to recruit 20-24 participants, and for the pre-post sites we aim to recruit 10 participants (total n=92 participants). Participants at the RCT sites will be randomized into Group-A (n = 12; immediate treatment intervention group) or Group-B (n = 12; delayed treatment intervention group). Group-A will receive the MAC intervention at the onset of the study, while Group-B will receive treatment as usual (TAU). Group-B will have the option of receiving the MAC intervention approximately 6 months after the onset of the study. At all times during this study, participants who are receiving the MAC intervention will also be able to continue receiving TAU. Both groups will be assessed with a battery of quantitative measures at baseline (T1), three months later (i.e., immediately post-MAC intervention) (T2), and again three months post-MAC intervention (T3). The measures include interview assessments of psychotic disorder symptoms, and self-report measures of affect, self-esteem, quality of life, coping strategies, assertiveness, social functioning, mindfulness and cognitive skills. In addition, healthcare utilization records for the 6 months preceding MAC intervention onset and for the 6 month duration of the study (3 month MAC intervention + 3 month post-MAC intervention follow-up period) will be collected. Researchers conducting symptom assessment interviews and data analysis will be blinded to the group membership of participants. For the two pre-post sites, all 10 participants will receive the MAC intervention immediately. All 10 participants will complete T1, T2, and T3 assessments and their healthcare utilization records will also be collected.

Based on the pilot study at PEPP-LHSC, and based on previous findings of Mindfulness Based Interventions for psychoses in the literature, we are expecting that participation in the MAC intervention will result in improvement in the following areas: psychotic symptomology (including affective symptoms), mindfulness skills, quality of life, measures of recovery (self-esteem, perceived recovery), perceived coping, assertiveness, social functioning, cognitive skills, and a reduction in healthcare service utilization (e.g., emergency room visits, inpatient admissions/length of hospitalization).


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Five sites in total are participating. Three of the five sites are following a RCT design (randomized group allocation; treatment and control group). Two of the five sites are following a pre-post design (no randomized allocation and no control group).
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mindfulness Group-based Intervention for Early Psychosis: A Multi-Site Randomized Control Trial
Actual Study Start Date : February 22, 2018
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Group-A - Immediate Intervention
Immediate Mindfulness Ambassador Council for Early Psychosis (MAC-EP)
Behavioral: 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. MAC has demonstrated acceptability, feasibility, and promising beneficial effects in schools, and in the pilot study conducted at the Early Psychosis Program at London Health Sciences Centre in London, Ontario. Its youth-focus and emphasis on building social and emotional competencies through mindfulness make it a promising intervention for youth recovering from their first episode of psychosis.

Group-B - Delayed Intervention
6 month treatment as usual waitlist followed by Mindfulness Ambassador Council for Early Psychosis (MAC-EP)
Behavioral: 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. MAC has demonstrated acceptability, feasibility, and promising beneficial effects in schools, and in the pilot study conducted at the Early Psychosis Program at London Health Sciences Centre in London, Ontario. Its youth-focus and emphasis on building social and emotional competencies through mindfulness make it a promising intervention for youth recovering from their first episode of psychosis.




Primary Outcome Measures :
  1. Self-Evaluation of Negative Symptoms (SNS) [ Time Frame: Baseline, change from Baseline in SNS at 3 months, change from Baseline in SNS at 6 months ]
    Self-report measure for the assessment of negative symptoms

  2. Kentucky Inventory of Mindfulness Skills [ Time Frame: Baseline, change from Baseline in KIMS at 3 months, change from Baseline in KIMS at 6 months ]
    Self-report measure of mindfulness skills


Secondary Outcome Measures :
  1. Rosenberg Self-Esteem Scale (RSES) [ Time Frame: Baseline, change from Baseline in RSES at 3 months, change from Baseline in RSES at 6 months ]
    self-report measure of self-esteem

  2. Profile of Mood States - Short Form (POMS-SF) [ Time Frame: Baseline, change from Baseline in POMS-SF at 3 months, change from Baseline in POMS-SF at 6 months ]
    self-report measure of mood

  3. World Health Organization Quality of Life Scale - Brief version (WHOQOL-BREF) [ Time Frame: Baseline, change from Baseline in WHOQOL at 3 months, change from Baseline in WHOQOL at 6 months ]
    self-report measure of quality of life

  4. Ways of Coping Questionnaire (WCQ) [ Time Frame: Baseline, change from Baseline in WCQ at 3 months, change from Baseline in WCQ at 6 months ]
    self-report measure of ways to cope

  5. Cognitive Failures Questionnaire (CFQ) [ Time Frame: Baseline, change from Baseline in CFQ at 3 months, change from Baseline in CFQ at 6 months ]
    self-report measure of cognitive failures

  6. Rathus Assertiveness Scale (RAS) [ Time Frame: Baseline, change from Baseline in RAS at 3 months, change from Baseline in RAS at 6 months ]
    self-report measure of assertiveness

  7. Health Care Utilization Records Post-Intervention [ Time Frame: Utilization at Baseline and during the 6 months following the mindfulness intervention ]
    form to document participant health care utilization

  8. 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 ]
    self-report measure of mindfulness skills

  9. Maryland Assessment of Recovery in People With Serious Mental Illness (MAR) [ Time Frame: Baseline, change from Baseline in MAR at 3 months, change from Baseline in MAR at 6 months ]
    self-report measure of perceived self-recovery

  10. First-Episode Social Functioning Scale (FESFS) [ Time Frame: Baseline, change from Baseline in FESFS at 3 months, change from Baseline in FESFS at 6 months ]
    self-report measure of social functioning



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants must currently be in treatment for psychosis at one of the five Early Psychosis Intervention (EPI) study sites. 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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03143907


Contacts
Contact: Arlene MacDougall, M.Sc. M.D. 519-685-8500 ext 47240 arlene.macdougall@sjhc.london.on.ca
Contact: Elizabeth Price, M.A. 519-685-8500 ext 58324 elizabeth.price@lhsc.on.ca

Locations
Canada, Ontario
Canadian Mental Health Association Chatham-Kent Health Alliance Recruiting
Chatham, Ontario, Canada, N7L 1C1
Contact: Rebecca Wilkes, MSW         
Canadian Mental Health Association Wellington-Waterloo Recruiting
Guelph, Ontario, Canada, N1H 0A1
Contact: Deborah Gauthier, MSW         
Cleghorn Early Psychosis Intervention Clinic Recruiting
Hamilton, Ontario, Canada, L9C 0E3
Contact: Elmar Gardizi, PhD         
Prevention and Early Intervention Program for Psychoses Completed
London, Ontario, Canada, N6A 5W9
Canadian Mental Health Association Lambton-Kent Recruiting
Sarnia, Ontario, Canada, N7T 4C7
Contact: Adrian Fortner, MA         
Sponsors and Collaborators
Lawson Health Research Institute
University of Western Ontario, Canada
London Health Sciences Centre
Mindfulness Without Borders
Investigators
Principal Investigator: Arlene MacDougall, M.Sc. M.D. University of Western Ontario/London Health Sciences Centre

Additional Information:
Publications:
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.

Responsible Party: Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT03143907     History of Changes
Other Study ID Numbers: 108941
First Posted: May 8, 2017    Key Record Dates
Last Update Posted: June 20, 2018
Last Verified: June 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Lawson Health Research Institute:
Mindfulness
Group Therapy

Additional relevant MeSH terms:
Schizophrenia
Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders