Mindfulness Group-based Intervention for Early Psychosis

Mindfulness Group-based Intervention for Early Psychosis: A Multi-Site Randomized Control Trial

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).

Study Overview

• Status: Completed
• Conditions: Psychotic Disorders; Schizophrenia
• Intervention / Treatment: Behavioral: Mindfulness Ambassador Council for Early Psychosis (MAC-EP)

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
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Chatham, Ontario, Canada, N7L 1C1
      • Canadian Mental Health Association Chatham-Kent Health Alliance
    • Guelph, Ontario, Canada, N1H 0A1
      • Canadian Mental Health Association Wellington-Waterloo
    • Hamilton, Ontario, Canada, L9C 0E3
      • Cleghorn Early Psychosis Intervention Clinic
    • London, Ontario, Canada, N6A 5W9
      • Prevention and Early Intervention Program for Psychoses
    • Sarnia, Ontario, Canada, N7T 4C7
      • Canadian Mental Health Association Lambton-Kent

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 35 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-Evaluation of Negative Symptoms (SNS)	Self-report measure for the assessment of negative symptoms	Baseline, change from Baseline in SNS at 3 months, change from Baseline in SNS at 6 months
Kentucky Inventory of Mindfulness Skills	Self-report measure of mindfulness skills	Baseline, change from Baseline in KIMS at 3 months, change from Baseline in KIMS at 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rosenberg Self-Esteem Scale (RSES)	self-report measure of self-esteem	Baseline, change from Baseline in RSES at 3 months, change from Baseline in RSES at 6 months
Profile of Mood States - Short Form (POMS-SF)	self-report measure of mood	Baseline, change from Baseline in POMS-SF at 3 months, change from Baseline in POMS-SF at 6 months
World Health Organization Quality of Life Scale - Brief version (WHOQOL-BREF)	self-report measure of quality of life	Baseline, change from Baseline in WHOQOL at 3 months, change from Baseline in WHOQOL at 6 months
Ways of Coping Questionnaire (WCQ)	self-report measure of ways to cope	Baseline, change from Baseline in WCQ at 3 months, change from Baseline in WCQ at 6 months
Cognitive Failures Questionnaire (CFQ)	self-report measure of cognitive failures	Baseline, change from Baseline in CFQ at 3 months, change from Baseline in CFQ at 6 months
Rathus Assertiveness Scale (RAS)	self-report measure of assertiveness	Baseline, change from Baseline in RAS at 3 months, change from Baseline in RAS at 6 months
Health Care Utilization Records Post-Intervention	form to document participant health care utilization	Utilization at Baseline and during the 6 months following the mindfulness intervention
Kentucky Inventory of Mindfulness Skills (KIMS)	self-report measure of mindfulness skills	Baseline, change from Baseline in KIMS at 3 months, change from Baseline in KIMS at 6 months
Maryland Assessment of Recovery in People With Serious Mental Illness (MAR)	self-report measure of perceived self-recovery	Baseline, change from Baseline in MAR at 3 months, change from Baseline in MAR at 6 months
First-Episode Social Functioning Scale (FESFS)	self-report measure of social functioning	Baseline, change from Baseline in FESFS at 3 months, change from Baseline in FESFS at 6 months

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute
• Collaborators: 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

Publications and helpful links

General Publications

• 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.
• Khoury B, Sharma M, Rush SE, Fournier C. Mindfulness-based stress reduction for healthy individuals: A meta-analysis. J Psychosom Res. 2015 Jun;78(6):519-28. doi: 10.1016/j.jpsychores.2015.03.009. Epub 2015 Mar 20.
• 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.
• 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.
• Birchwood M, Todd P, Jackson C. Early intervention in psychosis. The critical period hypothesis. Br J Psychiatry Suppl. 1998;172(33):53-9.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• Wenk-Sormaz H. Meditation can reduce habitual responding. Altern Ther Health Med. 2005 Mar-Apr;11(2):42-58.
• Chadwick P, Hughes S, Russell D, Russell I, Dagnan D. Mindfulness groups for distressing voices and paranoia: a replication and randomized feasibility trial. Behav Cogn Psychother. 2009 Jul;37(4):403-12. doi: 10.1017/S1352465809990166. Epub 2009 Jun 23.
• Chadwick P, Strauss C, Jones AM, Kingdon D, Ellett L, Dannahy L, Hayward M. Group mindfulness-based intervention for distressing voices: A pragmatic randomised controlled trial. Schizophr Res. 2016 Aug;175(1-3):168-173. doi: 10.1016/j.schres.2016.04.001. Epub 2016 Apr 14.

Helpful Links

• 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).
• Ministry of Health and Long-Term Care (MHLTC), Government of Ontario (2011). Early Psychosis Intervention Program Standards.
• Mindfulness Without Borders

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2018
• Primary Completion (Actual): May 31, 2020
• Study Completion (Actual): May 31, 2020

Study Registration Dates

• First Submitted: May 4, 2017
• First Submitted That Met QC Criteria: May 4, 2017
• First Posted (Actual): May 8, 2017

Study Record Updates

• Last Update Posted (Actual): September 24, 2020
• Last Update Submitted That Met QC Criteria: September 22, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Mindfulness; Group Therapy
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Psychotic Disorders; Mental Disorders
• Other Study ID Numbers: 108941

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No