Mindfulness Group-based Intervention for Early Psychosis
Condition: Psychotic Disorders; Schizophrenia
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional

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).
    

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).
    

Intervention name(s): Mindfulness Ambassador Council for Early Psychosis (MAC-EP)
Intervention type(s): Behavioral
Intervention description(s): 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.
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
Keywords: Mindfulness; Group Therapy