Clinical trial NCT03143907: Mindfulness Group-based Intervention for Early Psychosis
Official title: Mindfulness Group-based Intervention for Early Psychosis: A Multi-Site Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychotic Disorders
Schizophrenia
Keywords: Mindfulness
Group Therapy
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: University of Western Ontario, Canada
name: London Health Sciences Centre
name: Mindfulness Without Borders
First posted: 2017-05-08
Enrollment: 70
Sex: ALL
Minimum age (years): 16
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: TREATMENT

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).

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Self-Evaluation of Negative Symptoms (SNS)
timeFrame: Baseline, change from Baseline in SNS at 3 months, change from Baseline in SNS at 6 months
measure: Kentucky Inventory of Mindfulness Skills
timeFrame: Baseline, change from Baseline in KIMS at 3 months, change from Baseline in KIMS at 6 months
Secondary outcomes:
measure: Rosenberg Self-Esteem Scale (RSES)
timeFrame: Baseline, change from Baseline in RSES at 3 months, change from Baseline in RSES at 6 months
measure: Profile of Mood States - Short Form (POMS-SF)
timeFrame: Baseline, change from Baseline in POMS-SF at 3 months, change from Baseline in POMS-SF at 6 months
measure: World Health Organization Quality of Life Scale - Brief version (WHOQOL-BREF)
timeFrame: Baseline, change from Baseline in WHOQOL at 3 months, change from Baseline in WHOQOL at 6 months
measure: Ways of Coping Questionnaire (WCQ)
timeFrame: Baseline, change from Baseline in WCQ at 3 months, change from Baseline in WCQ at 6 months
measure: Cognitive Failures Questionnaire (CFQ)
timeFrame: Baseline, change from Baseline in CFQ at 3 months, change from Baseline in CFQ at 6 months
measure: Rathus Assertiveness Scale (RAS)
timeFrame: Baseline, change from Baseline in RAS at 3 months, change from Baseline in RAS at 6 months
measure: Health Care Utilization Records Post-Intervention
timeFrame: Utilization at Baseline and during the 6 months following the mindfulness intervention
measure: Kentucky Inventory of Mindfulness Skills (KIMS)
timeFrame: Baseline, change from Baseline in KIMS at 3 months, change from Baseline in KIMS at 6 months
measure: Maryland Assessment of Recovery in People With Serious Mental Illness (MAR)
timeFrame: Baseline, change from Baseline in MAR at 3 months, change from Baseline in MAR at 6 months
measure: First-Episode Social Functioning Scale (FESFS)
timeFrame: Baseline, change from Baseline in FESFS at 3 months, change from Baseline in FESFS at 6 months
Other outcomes:
Locations:
city: Chatham
country: Canada
facility: Canadian Mental Health Association Chatham-Kent Health Alliance
state: Ontario
city: Guelph
country: Canada
facility: Canadian Mental Health Association Wellington-Waterloo
state: Ontario
city: Hamilton
country: Canada
facility: Cleghorn Early Psychosis Intervention Clinic
state: Ontario
city: London
country: Canada
facility: Prevention and Early Intervention Program for Psychoses
state: Ontario
city: Sarnia
country: Canada
facility: Canadian Mental Health Association Lambton-Kent
state: Ontario
Study officials:
affiliation: University of Western Ontario/London Health Sciences Centre
name: Arlene MacDougall, M.Sc. M.D.
role: PRINCIPAL_INVESTIGATOR
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