Comparative Effectiveness of CET vs. SST in SMI (Serious Mental Illness)

November 13, 2023 updated by: Matcheri S. Keshavan MD, Beth Israel Deaconess Medical Center

Comparative Effectiveness of Cognitive Enhancement Therapy vs. Social Skills Training in Serious Mental Illness

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Aim 1. We will test our hypothesis that CET will be associated with greater improvements than SST in both the primary outcome: community functioning (SAS, QLS), and the secondary outcomes of neuro- and social cognition (NIH Toolbox, PennCNB, and MSCEIT) and social skills (SSPA). For study Aim 1, we hypothesized that CET will be associated with greater improvements than SST in both the primary outcome: community functioning (SAS, QLS), and the secondary outcomes of neuro- and social cognition (selected NIH Toolbox and Penn CNB measures, and MSCEIT) and social skills (SSPA). Aim 2: We will explore differential effectiveness of the two interventions by baseline cognitive functioning and age. For Aim 2, we hypothesize that patients with less impairment in cognitive functioning at baseline will demonstrate relatively larger treatment gains in SST compared to those in CET than those who are initially more cognitively impaired, and that younger patients will benefit more from CET compared to those in SST than those who are older. The results of this study will address a key knowledge gap in the field and a decisional dilemma for clinicians. A pilot study at four treatment sites will be used to test the feasibility and acceptability of telementalhealth delivery of these two treatments, as compared to in-person delivery.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
378

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Connecticut
      • Hartford, Connecticut, United States, 06106
        • Recruiting
        • Hartford Hospital - Institute of Living
        • Contact:
          • Jimmy Choi, PsyD
    • Maine
      • Portland, Maine, United States, 04102
        • Recruiting
        • Maine Medical Center
        • Contact:
          • Kristen Woodberry, MSW, PhD
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Active, not recruiting
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Massachusetts Mental Health Center
        • Contact:
          • Fred Crow, MD
      • Worcester, Massachusetts, United States, 01603
        • Recruiting
        • UMass Medical School
        • Contact:
          • Xaioduo Fan, MD, MPH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: 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.
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..
Behavioral: 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 Names:
  • HOPES

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Social Adjustment Scale II
Time Frame: Measurement at 0, 6, 12, 18, 24 months
Measure of social functioning
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
Measure of social functioning
Measurement at 0, 6, 12, 18, 24 months
Change in Social Skills Performance Assessment
Time Frame: Measurement at 0, 6, 12, 18, 24 months
Measure of social functioning using role played scenarios
Measurement at 0, 6, 12, 18, 24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Auditory Verbal Learning Test
Time Frame: Measurement at 0, 6, 12, 18, 24 months
Neurocognition measure of verbal ability in NIH Toolbox
Measurement at 0, 6, 12, 18, 24 months
Change in List Sorting Working Memory
Time Frame: Measurement at 0, 6, 12, 18, 24 months
Neurocognition measure of working memory in NIH Toolbox
Measurement at 0, 6, 12, 18, 24 months
Change in Positive and Negative Syndrome Scale, PANSS-6
Time Frame: Measurement at 0, 6, 12, 18, 24 months
Short form of measure of positive and negative symptoms
Measurement at 0, 6, 12, 18, 24 months
Change in Picture Sequence Memory
Time Frame: Measurement at 0, 6, 12, 18, 24 months
Neurocognition measure of visual/episodic memory & learning in NIH Toolbox
Measurement at 0, 6, 12, 18, 24 months
Change in Picture Vocabulary
Time Frame: Measurement at 0, 6, 12, 18, 24 months
Neurocognition measure of language in NIH Toolbox
Measurement at 0, 6, 12, 18, 24 months
Change in Oral Reading Recognition
Time Frame: Measurement at 0, 6, 12, 18, 24 months
Neurocognition measure of language in NIH Toolbox
Measurement at 0, 6, 12, 18, 24 months
Change in Penn Mouse Practice Test
Time Frame: Measurement at 0, 6, 12, 18, 24 months
Neurocognition measure of speed of processing in PennCNB
Measurement at 0, 6, 12, 18, 24 months
Change in Penn Digit Symbol Test
Time Frame: Measurement at 0, 6, 12, 18, 24 months
Neurocognition measure of speed of processing in PennCNB
Measurement at 0, 6, 12, 18, 24 months
Change in Penn Conditional Exclusion Test
Time Frame: Measurement at 0, 6, 12, 18, 24 months
Neurocognition measure of reasoning & problem solving in PennCNB
Measurement at 0, 6, 12, 18, 24 months
Change in Penn Continuous Performance Test
Time Frame: Measurement at 0, 6, 12, 18, 24 months
Neurocognition measure of reasoning & problem solving in PennCNB
Measurement at 0, 6, 12, 18, 24 months
Change in Managing Emotions
Time Frame: Measurement at 0, 6, 12, 18, 24 months
Subscale of the Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT)
Measurement at 0, 6, 12, 18, 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Beth Israel Deaconess Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Patient-Centered Outcomes Research Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Matcheri S Keshavan, MD, Beth Israel Deaconess Medical Center
  • Principal Investigator: Russell K Schutt, PhD, Beth Israel Deaconess Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 18, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2020

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 14, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 13, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2020P000094
  • CER-2018C3-14701 (Other Grant/Funding Number: PCORI)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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