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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of a schizophrenia spectrum or other psychotic disorder including affective psychosis
At least 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up evaluation time 20 minutes
Awards & highlights
SSERT Trial Summary
This trial will study if an intervention called SSERT is feasible and acceptable for people with psychotic disorder who have also experienced trauma.
Who is the study for?
This trial is for adults over 18 with a psychotic disorder and past trauma, who are stable on antipsychotic meds, without severe substance use disorders or cognitive-impacting medical conditions. Participants must have some difficulty with emotion regulation or social skills and speak French or English.Check my eligibility
What is being tested?
The study tests SSERT (Social Skills and Emotion Regulation Training) to see if it's workable and helpful for those with psychosis affected by trauma. It aims to improve how they handle emotions and interact socially.See study design
What are the potential side effects?
Since SSERT involves training rather than medication, typical drug side effects aren't expected. However, participants may experience emotional discomfort when discussing traumatic experiences or practicing new skills.
SSERT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with schizophrenia or a similar psychotic disorder.
Select...
I am 18 years old or older.
SSERT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ evaluation time 20 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~evaluation time 20 minutes
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adverse events
Client Motivation for Therapy Scale
Client Satisfaction Questionnaire
+4 moreSecondary outcome measures
Emotion Regulation Skills Questionnaire
Inventory of Interpersonal Problems- 32
Other outcome measures
Abbreviated- Quality of Life Enjoyment and Satisfaction Questionnaire
Beck Cognitive Insight Scale
Brief COPE scale
+8 moreSSERT Trial Design
1Treatment groups
Experimental Treatment
Group I: Intervention SSERTExperimental Treatment1 Intervention
The SSERT intervention will take place over 10 weekly individual intervention sessions of 60 minutes. SSERT for trauma history in psychosis will draw inspiration from the Skills Training in Affective and Interpersonal Regulation intervention as well as other CBT and DBT-based interventions for emotion regulation and social skills functioning. Therapists will be provided with a semi-structured manual that can be implemented flexibly to consider participant needs.
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Who is running the clinical trial?
McGill UniversityLead Sponsor
394 Previous Clinical Trials
998,361 Total Patients Enrolled
1 Trials studying Emotion Regulation
40 Patients Enrolled for Emotion Regulation
Douglas Mental Health University InstituteLead Sponsor
29 Previous Clinical Trials
2,706 Total Patients Enrolled
1 Trials studying Emotion Regulation
40 Patients Enrolled for Emotion Regulation
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am on a steady dose of medication for my mental health.I speak French or English.I have been diagnosed with schizophrenia or a similar psychotic disorder.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention SSERT
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the recruitment rate for this clinical trial?
"Affirmative. Records on clinicaltrials.gov demonstrate that this medical trial is actively looking to recruit patients. It was initially posted in July 2021 and last edited October 2022, with the aim of recruiting 20 individuals across a single location."
Answered by AI
Are recruitment efforts currently underway for this investigation?
"Per the details on clinicaltrials.gov, this research project is actively searching for participants. The first posting was made July 1st 2021 and last modified October 21st 2022."
Answered by AI
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