Mindfulness Group-based Intervention for Early Psychosis

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03143907
• Other study ID #: 108941
• Status: Completed
• Phase: N/A
• Start date: February 22, 2018
• Est. completion date: May 31, 2020

Study information

• Verified date: September 2020
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: May 31, 2020
• Est. primary completion date: May 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Mental Disorders
• Psychotic Disorders
• Schizophrenia

Intervention

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.

Locations

Country	Name	City	State
Canada	Canadian Mental Health Association Chatham-Kent Health Alliance	Chatham	Ontario
Canada	Canadian Mental Health Association Wellington-Waterloo	Guelph	Ontario
Canada	Cleghorn Early Psychosis Intervention Clinic	Hamilton	Ontario
Canada	Prevention and Early Intervention Program for Psychoses	London	Ontario
Canada	Canadian Mental Health Association Lambton-Kent	Sarnia	Ontario

Sponsors (4)

Lead Sponsor	Collaborator
Lawson Health Research Institute	London Health Sciences Centre, Mindfulness Without Borders, University of Western Ontario, Canada

Country where clinical trial is conducted

Canada, 

References & Publications (14)

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. — View Citation

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

Buchanan RW. Persistent negative symptoms in schizophrenia: an overview. Schizophr Bull. 2007 Jul;33(4):1013-22. Epub 2006 Nov 10. Review. — View Citation

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. — View Citation

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. — View Citation

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.

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External 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
•   Ministry of Health and Long-Term Care (MHLTC), Government of Ontario (2011). Early Psychosis Intervention Program Standards.