Recruiting

CET vs. SST

Sponsor:

Beth Israel Deaconess Medical Center

Code:

NCT04321759

Conditions

Schizophrenia and Related Disorders

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Cognitive Enhancement Therapy

Social Skills Training

Study Details

Brief summary:

To compare two evidence-based treatments, Cognitive Enhancement Therapy (CET) and Social Skills Training (SST) that have been shown in meta-analyses and in our own research to be effective to improve community functioning. The investigators will test the impact of CET and SST on community functioning, with special attention to their relative effectiveness for patients differing in baseline cognitive skills and age. The research uses a cluster design in which different mental health service centers are randomized to one of the two treatments.

Conditions

Schizophrenia and Related Disorders

Study ID

NCT04321759

Start date

Jun 1, 2021

Status verified date

Nov, 2023

Completion date

Jan 31, 2026

Anticipated

Primary completion date

Jan 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. age 18 to 65;
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:

1. the presence of a current organic brain syndrome;
2. intellectual disability (DSM-5);
3. participation in either CET or SST within the prior year.

Study Design

Enrollment

378 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

active comparator: 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..

Interventions

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.

Primary outcome measure

  • Change in Social Adjustment Scale II [ Time Frame: Measurement at 0, 6, 12, 18, 24 months ]
  • Change in Heinrich Quality of Life Scale [ Time Frame: Measurement at 0, 6, 12, 18, 24 months ]
  • Change in Social Skills Performance Assessment [ Time Frame: Measurement at 0, 6, 12, 18, 24 months ]

Central Contacts and Locations

Locations

Hartford Hospital - Institute of Living

Recruiting

Hartford, Connecticut, United States, 06106

Maine Medical Center

Recruiting

Portland, Maine, United States, 04102

Massachusetts Mental Health Center

Recruiting

Boston, Massachusetts, United States, 02115

UMass Medical School

Recruiting

Worcester, Massachusetts, United States, 01603

More Information

Sponsor

Beth Israel Deaconess Medical Center

Last update posted

Nov 14, 2023

Last verified

Nov, 2023

Keywords

  • Cognitive functioning
  • Social skills
  • Community functioning

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Beth Israel Deaconess Medical Center on 2023-11-14.