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

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: Recruiting
• Conditions: Schizophrenia and Related Disorders
• Intervention / Treatment: Behavioral: Cognitive Enhancement Therapy; Behavioral: Social Skills Training

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: Interventional
• Enrollment (Estimated): 378
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Blanche Spindell; Phone Number: 617-735-4261; Email: bspindel@bidmc.harvard.edu
• Study Contact Backup: Name: Jennifer Sabbagh; Phone Number: 58545 617-975-8545; Email: jsabbagh@bidmc.harvard.edu

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Change in Social Adjustment Scale II	Measure of social functioning	Measurement at 0, 6, 12, 18, 24 months
Change in Heinrich Quality of Life Scale	Measure of social functioning	Measurement at 0, 6, 12, 18, 24 months
Change in Social Skills Performance Assessment	Measure of social functioning using role played scenarios	Measurement at 0, 6, 12, 18, 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Auditory Verbal Learning Test	Neurocognition measure of verbal ability in NIH Toolbox	Measurement at 0, 6, 12, 18, 24 months
Change in List Sorting Working Memory	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	Short form of measure of positive and negative symptoms	Measurement at 0, 6, 12, 18, 24 months
Change in Picture Sequence Memory	Neurocognition measure of visual/episodic memory & learning in NIH Toolbox	Measurement at 0, 6, 12, 18, 24 months
Change in Picture Vocabulary	Neurocognition measure of language in NIH Toolbox	Measurement at 0, 6, 12, 18, 24 months
Change in Oral Reading Recognition	Neurocognition measure of language in NIH Toolbox	Measurement at 0, 6, 12, 18, 24 months
Change in Penn Mouse Practice Test	Neurocognition measure of speed of processing in PennCNB	Measurement at 0, 6, 12, 18, 24 months
Change in Penn Digit Symbol Test	Neurocognition measure of speed of processing in PennCNB	Measurement at 0, 6, 12, 18, 24 months
Change in Penn Conditional Exclusion Test	Neurocognition measure of reasoning & problem solving in PennCNB	Measurement at 0, 6, 12, 18, 24 months
Change in Penn Continuous Performance Test	Neurocognition measure of reasoning & problem solving in PennCNB	Measurement at 0, 6, 12, 18, 24 months
Change in Managing Emotions	Subscale of the Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT)	Measurement at 0, 6, 12, 18, 24 months

Collaborators and Investigators

• Sponsor: Beth Israel Deaconess Medical Center
• Collaborators: Patient-Centered Outcomes Research Institute
• Investigators: 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

General Publications

• 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. Erratum In: BMC Psychiatry. 2022 Sep 16;22(1):613.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Estimated): January 31, 2026
• Study Completion (Estimated): January 31, 2026

Study Registration Dates

• First Submitted: March 18, 2020
• First Submitted That Met QC Criteria: March 24, 2020
• First Posted (Actual): March 25, 2020

Study Record Updates

• Last Update Posted (Estimated): November 14, 2023
• Last Update Submitted That Met QC Criteria: November 13, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Social skills; Cognitive functioning; Community functioning
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Mental Disorders
• Other Study ID 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