CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 58 enrolled
Drug / intervention
CLUES +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02459210
NCT02459210N/ACompleted

CLUES (Cognition for Learning and for Understanding Everyday Social Situations): An Adaptation of Cognitive Enhancement Therapy for Persons at Clinical High Risk for Psychosis

Beth Israel Deaconess Medical Center·interventional·Posted Jun 2, 2015·Updated May 7, 2019

In Brief

A clinical study evaluating CLUES and therapy and computer games for Psychosis. Completed, enrolled 58 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPsychosis
CountriesUnited States

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedJun 2, 2015
Enrollment StartJan 1, 2015
Primary CompletionJan 1, 2019
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 11.1 years ago

Interventions

CLUESbehavioral

Cognition for learning and for understanding everyday social situations intervention described above

therapy and computer gamesbehavioral

Weekly psychotherapy+ computer games such as sporcle