Ignite Creation Date:
2024-05-06 @ 10:02 AM
Last Modification Date:
2024-10-26 @ 12:23 PM
Study NCT ID:
NCT03143907
Status:
COMPLETED
Last Update Posted:
2020-09-24
First Post:
2017-05-04
Brief Title:
Mindfulness Group-based Intervention for Early Psychosis
Sponsor:
Lawson Health Research Institute
Organization:
Lawson Health Research Institute
Study Overview
Official Title:
Mindfulness Group-based Intervention for Early Psychosis A Multi-Site Randomized Control Trial
Status:
COMPLETED
Status Verified Date:
2020-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Recent research has suggested that mindfulness-based interventions MBI for psychosis may be effective in reducing the negative symptoms of schizophrenia eg social withdrawal lack of motivation and the distress associated with psychotic symptoms eg 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 eg 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 eg emergency room visits inpatient admissionslength 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 n92 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 ie 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 eg emergency room visits inpatient admissionslength of hospitalization
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 n92 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 ie 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 eg emergency room visits inpatient admissionslength of hospitalization
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None