Mindfulness Group-based Intervention for Early Psychosis

NCT03143907 | Completed

• 1 other identifier: 108941
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 5

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).

Conditions

Psychotic Disorders; Schizophrenia

Keywords

Mindfulness; Group Therapy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• Rosenberg Self-Esteem Scale (RSES)

  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)

  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)

  Baseline, change from Baseline in WHOQOL at 3 months, change from Baseline in WHOQOL at 6 months

• Ways of Coping Questionnaire (WCQ)

  Baseline, change from Baseline in WCQ at 3 months, change from Baseline in WCQ at 6 months

• Cognitive Failures Questionnaire (CFQ)

  Baseline, change from Baseline in CFQ at 3 months, change from Baseline in CFQ at 6 months

Study Arms (2)

Group-A - Immediate Intervention

OTHER

Immediate Mindfulness Ambassador Council for Early Psychosis (MAC-EP)

Behavioral: Mindfulness Ambassador Council for Early Psychosis (MAC-EP)

Group-B - Delayed Intervention

OTHER

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)

Interventions

Mindfulness Ambassador Council for Early Psychosis (MAC-EP) BEHAVIORAL

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-A - Immediate Intervention; Group-B - Delayed Intervention

Eligibility Criteria

• Age: 16 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• University of Western Ontario, Canada: collaborator
• London Health Sciences Centre: collaborator
• Mindfulness Without Borders: collaborator

Study Sites (5)

Canadian Mental Health Association Chatham-Kent Health Alliance

Chatham, Ontario, N7L 1C1, Canada

Location

Canadian Mental Health Association Wellington-Waterloo

Guelph, Ontario, N1H 0A1, Canada

Location

Cleghorn Early Psychosis Intervention Clinic

Hamilton, Ontario, L9C 0E3, Canada

Location

Prevention and Early Intervention Program for Psychoses

London, Ontario, N6A 5W9, Canada

Location

Canadian Mental Health Association Lambton-Kent

Sarnia, Ontario, N7T 4C7, Canada

Location

Related Publications (14)

• 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.

  PMID: 23796855 BACKGROUND

• 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.

  PMID: 25818837 BACKGROUND

• 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.

  PMID: 21976710 BACKGROUND

• Birchwood M, Todd P, Jackson C. Early intervention in psychosis. The critical period hypothesis. Br J Psychiatry Suppl. 1998;172(33):53-9.

  PMID: 9764127 BACKGROUND

• 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.

  PMID: 23616779 BACKGROUND

• 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.

  PMID: 24220133 BACKGROUND

• 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.

  PMID: 21549566 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 17099070 BACKGROUND

• 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.

  PMID: 25329321 BACKGROUND

• Wenk-Sormaz H. Meditation can reduce habitual responding. Altern Ther Health Med. 2005 Mar-Apr;11(2):42-58.

  PMID: 15819448 BACKGROUND

• 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.

  PMID: 20363650 BACKGROUND

• 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.

  PMID: 19545481 BACKGROUND

• 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.

  PMID: 27146475 BACKGROUND

Related 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).
• Mindfulness Without Borders

MeSH Terms

Conditions

Psychotic Disorders; Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Arlene MacDougall, M.Sc. M.D.

  University of Western Ontario/London Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: May 4, 2017
• First Posted: May 8, 2017
• Study Start: February 22, 2018
• Primary Completion: May 31, 2020
• Study Completion: May 31, 2020
• Last Updated: September 24, 2020

Record last verified: 2020-09

Locations

CA (5)