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

Schizophrenia and Related Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04321759
• Other study ID #: 2020P000094
• Secondary ID: CER-2018C3-14701
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: January 31, 2026

Study information

• Verified date: November 2023
• Source: Beth Israel Deaconess Medical Center
• Contact: Jennifer Sabbagh
• Phone: 617-975-8545
• Email: jsabbagh[@]bidmc.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 378
• Est. completion date: January 31, 2026
• Est. primary completion date: January 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Mental Disorders
• Schizophrenia
• Schizophrenia and Related Disorders

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Massachusetts Mental Health Center	Boston	Massachusetts
United States	Hartford Hospital - Institute of Living	Hartford	Connecticut
United States	Maine Medical Center	Portland	Maine
United States	UMass Medical School	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Social Adjustment Scale II	Measure of social functioning	Measurement at 0, 6, 12, 18, 24 months
Primary	Change in Heinrich Quality of Life Scale	Measure of social functioning	Measurement at 0, 6, 12, 18, 24 months
Primary	Change in Social Skills Performance Assessment	Measure of social functioning using role played scenarios	Measurement at 0, 6, 12, 18, 24 months
Secondary	Change in Auditory Verbal Learning Test	Neurocognition measure of verbal ability in NIH Toolbox	Measurement at 0, 6, 12, 18, 24 months
Secondary	Change in List Sorting Working Memory	Neurocognition measure of working memory in NIH Toolbox	Measurement at 0, 6, 12, 18, 24 months
Secondary	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
Secondary	Change in Picture Sequence Memory	Neurocognition measure of visual/episodic memory & learning in NIH Toolbox	Measurement at 0, 6, 12, 18, 24 months
Secondary	Change in Picture Vocabulary	Neurocognition measure of language in NIH Toolbox	Measurement at 0, 6, 12, 18, 24 months
Secondary	Change in Oral Reading Recognition	Neurocognition measure of language in NIH Toolbox	Measurement at 0, 6, 12, 18, 24 months
Secondary	Change in Penn Mouse Practice Test	Neurocognition measure of speed of processing in PennCNB	Measurement at 0, 6, 12, 18, 24 months
Secondary	Change in Penn Digit Symbol Test	Neurocognition measure of speed of processing in PennCNB	Measurement at 0, 6, 12, 18, 24 months
Secondary	Change in Penn Conditional Exclusion Test	Neurocognition measure of reasoning & problem solving in PennCNB	Measurement at 0, 6, 12, 18, 24 months
Secondary	Change in Penn Continuous Performance Test	Neurocognition measure of reasoning & problem solving in PennCNB	Measurement at 0, 6, 12, 18, 24 months
Secondary	Change in Managing Emotions	Subscale of the Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT)	Measurement at 0, 6, 12, 18, 24 months

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