Comparative Effectiveness of CET vs. SST in SMI (Serious Mental Illness)
NCT ID: NCT04321759
Last Updated: 2023-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
378 participants
INTERVENTIONAL
2021-06-01
2026-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
RCT Social Cognition Training and Therapeutic Alliance Focused Therapy for Persons With Severe Mental Illness
NCT02380885
Evaluating the Use of Peer Specialists to Deliver Cognitive Behavioral Social Skills Training
NCT03467243
The Use of Skills Training to Augment Compensated Work Therapy (CWT)/VI for Veterans With SMI
NCT00272168
CBT Enhanced With Social Cognitive Training
NCT03954392
Outcomes From Remediation and Behavioural Intervention Techniques
NCT05731414
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Cognitive Enhancement Therapy
CET is a comprehensive manualized cognitive remediation program designed to maximize gains in social functioning by integrating computer-based training to enhance neurocognition with group-based exercises to improve social cognition.
Cognitive Enhancement Therapy
CET's group-based exercises are delivered for 1.5 hours each week in a group of 6-8 participants led by a clinician and an assistant, for one year. During each of three modules (basic concepts, social cognition, CET applications), the groups focus on acquisition of adult social milestones in perspective-taking, social context appraisal, and other aspects of social cognition, with psychoeducational lectures, homework assignments, and in-group exercises. Weekly supervision sessions for the clinician trainers will include review of how patients respond to the different demands of computer-based training and group-based exercises and guidance about improving engagement in both.
Social Skills Training
The HOPES social rehabilitation program uses the principles of SST (modeling, role playing, positive and corrective feedback, homework assignments, in vivo skills practice), designed to improve both psychosocial functioning and preventive health..
Social Skills Training
The psychosocial component involves weekly skills training classes delivered over one year, with modules including "Communicating Effectively," "Making and Keeping Friends," "Making the Most of Leisure Time," "Healthy Living," "Using Medications Effectively," and "Making the Most of a Health Care Visit" (Pratt et al., 2008). Participants attend two sessions each week (normally morning and afternoon of the same day): a 90-minute session focused on a specific skill and a 60-minute session in which the specific skill is used in role-play exercises.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Cognitive Enhancement Therapy
CET's group-based exercises are delivered for 1.5 hours each week in a group of 6-8 participants led by a clinician and an assistant, for one year. During each of three modules (basic concepts, social cognition, CET applications), the groups focus on acquisition of adult social milestones in perspective-taking, social context appraisal, and other aspects of social cognition, with psychoeducational lectures, homework assignments, and in-group exercises. Weekly supervision sessions for the clinician trainers will include review of how patients respond to the different demands of computer-based training and group-based exercises and guidance about improving engagement in both.
Social Skills Training
The psychosocial component involves weekly skills training classes delivered over one year, with modules including "Communicating Effectively," "Making and Keeping Friends," "Making the Most of Leisure Time," "Healthy Living," "Using Medications Effectively," and "Making the Most of a Health Care Visit" (Pratt et al., 2008). Participants attend two sessions each week (normally morning and afternoon of the same day): a 90-minute session focused on a specific skill and a 60-minute session in which the specific skill is used in role-play exercises.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. DSM-5 diagnosis of schizophrenia or schizoaffective or schizophreniform disorder (confirmed via the MINI diagnostic interview);
3. estimated IQ of \> 70 (established via WTAR).
Exclusion Criteria
2. intellectual disability (DSM-5);
3. participation in either CET or SST within the prior year.
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Patient-Centered Outcomes Research Institute
OTHER
Beth Israel Deaconess Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Matcheri S. Keshavan MD
Stanley Cobb Professor and Academic Head of Psychiatry, Department of Psychiatry,
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Matcheri S Keshavan, MD
Role: PRINCIPAL_INVESTIGATOR
Beth Israel Deaconess Medical Center
Russell K Schutt, PhD
Role: PRINCIPAL_INVESTIGATOR
Beth Israel Deaconess Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hartford Hospital - Institute of Living
Hartford, Connecticut, United States
Maine Medical Center
Portland, Maine, United States
Massachusetts Mental Health Center
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
UMass Medical School
Worcester, Massachusetts, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Jimmy Choi, PsyD
Role: primary
Kristen Woodberry, MSW, PhD
Role: primary
Fred Crow, MD
Role: primary
Xaioduo Fan, MD, MPH
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
Schutt RK, Xie H, Mueser KT, Killam MA, Delman J, Eack SM, Mesholam-Gately R, Pratt SI, Sandoval L, Santos MM, Golden LR, Keshavan MS. Cognitive Enhancement Therapy vs social skills training in schizophrenia: a cluster randomized comparative effectiveness evaluation. BMC Psychiatry. 2022 Sep 1;22(1):583. doi: 10.1186/s12888-022-04149-x.
Related Links
Access external resources that provide additional context or updates about the study.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CER-2018C3-14701
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2020P000094
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.