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Completed

NCT Number: NCT03143907

Mindfulness Group-based Intervention for Early Psychosis

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).

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Key information

Conditions

Psychotic Disorders Mental Disorders Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders

Age range

16 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Canadian Mental Health Association Chatham-Kent Health Alliance, Chatham, Ontario, Canada

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Other

Collaborators

  • London Health Sciences Centre
  • Mindfulness Without Borders
  • University of Western Ontario, Canada

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
May 8, 2017
Registry last updated
Sep 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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