Adaptation of Cognitive Enhancement Therapy for Persons at Clinical High Risk for Psychosis (NCT02459210) | Clinical Trial Compass
CompletedNot Applicable
Adaptation of Cognitive Enhancement Therapy for Persons at Clinical High Risk for Psychosis
United States58 participantsStarted 2015-01
Plain-language summary
The purpose of this study is to test the feasibility of a modification of CET (Cognitive Enhancement Therapy) to address symptomatic and functional difficulties associated with Clinical High Risk for Psychosis (CHR).
Cognition for Learning and for Understanding Everyday Social Situations (CLUES) is designed to improve cognitive functioning (e.g., memory, attention, planning, etc.) in order to improve school, work, and social functioning. CLUES includes the following:
1. Computerized cognitive remediation ("exercises") to improve cognition.
2. Social-cognitive skills group designed to teach participants to act wisely in social situations.
3. Individual coaching sessions designed to enhance translation of skills learned from computer exercises and the group into real life.
CLUES is based on Hogarty and Greenwald's Cognitive Enhancement Therapy (CET), which was designed for treating individuals with schizophrenia. Research on CET for individuals with schizophrenia has found that CET appears to have helped participants improve cognition and social and work functioning.
This study will investigate the feasibility of CLUES for young people who are showing signs of clinical risk for psychosis.
Part 1: Preliminary open label trial of CLUES (n=8) to examine preliminary evidence of target engagement (change in cognition and social cognition), to refine assessment and recruitment approaches, to further optimize the treatment manual, and to ascertain feasibility and tolerability.
Part 2: Preliminary randomized controlled trial of CLUES vs supportive therapy (ST) + computer games to explore preliminary evidence of efficacy of CLUES vs. the control treatment (n=30).
Who can participate
Age range
16 Years – 25 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:
Broad criteria for clinical high risk for psychosis including meeting for SIPS clinical high risk syndrome or any two of the following:
* Trait risk: Having a first degree relative with a psychotic disorder, or a schizotypal disorder in the patient
* Positive symptoms: One or more of the attenuated SOPS Positive or Disorganized items scoring mild (3), moderate (4) or severe (5) but not at a psychotic level; these may include one or more Basic Symptoms (Klosterkotter et al 2001).
* Negative symptoms: Two or more of the SOPS negative symptoms rated at least moderate in severity
* Cognition: executive cognitive impairment (at least 1.0 standard deviation deficit relative to age-expected norms on at least 30% of the measures
* Functioning: GAF decline \> 30% over the last 2 years, sustained for \> 1 mo.
Exclusion Criteria:
* History of meeting full criteria for psychotic disorder
* Significant neurological or medical disorders that may produce cognitive impairment (e.g., seizure disorder, traumatic brain injury)
* More than 6 months (lifetime) of exposure to antipsychotic treatment
* A recent (within the past 3 months) history of substance abuse or dependence
* IQ \< 80
* Failure to achieve at least a 6th grade reading level
* Persistent suicidal or homicidal behavior
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 from Baseline in Social and Role Functioning at 6 Month and 9 Month (clinical interview)