Promoting Activity and Cognitive Enrichment in Schizophrenia (PACES) (NCT04143126) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Promoting Activity and Cognitive Enrichment in Schizophrenia (PACES)
United States90 participantsStarted 2019-10-01
Plain-language summary
This project will conduct a confirmatory efficacy trial of two novel psychosocial interventions, Cognitive Enhancement Therapy and Enriched Supportive Therapy, for the treatment of persistent negative symptoms in schizophrenia.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. are between 18-60 years of age;
. have a diagnosis of schizophrenia or schizoaffective disorder confirmed by the SCID;
. have a clinical history of persistent negative symptoms lasting at least 3 months as identified from the medical record;
. have observed persistent negative symptoms at the beginning and end of the 4-week evaluation period;
. have been stabilized on antipsychotic medication at the beginning and end of the 4-week evaluation period;
. have stabilized depressive symptoms at the beginning and end of the 4-week evaluation period;
. have mild or absent extrapyramidal symptoms at the beginning and end of the 4-week evaluation period;
. have had changes to their primary antipsychotic medication within the previous 3 months;
Exclusion criteria
. the presence of organic brain syndrome;
. comorbid medical disorders producing cognitive impairment (e.g., mild brain injury, previous concussions with loss of consciousness);
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Persistent Negative Symptoms
Timeframe: Prior to treatment, 6 months, 12, months, 18 months, 21 months and 30 months