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

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ClinicalTrials.gov Identifier: NCT04321759
Recruitment Status : Recruiting
First Posted : March 25, 2020
Last Update Posted : April 8, 2022
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Matcheri S. Keshavan MD, Beth Israel Deaconess Medical Center

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.

Condition or disease Intervention/treatment Phase
Schizophrenia and Related Disorders Behavioral: Cognitive Enhancement Therapy Behavioral: Social Skills Training Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 378 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized cluster design with 19 service centers assigned to one of the two treatments.
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparative Effectiveness of Cognitive Enhancement Therapy vs. Social Skills Training in Serious Mental Illness
Actual Study Start Date : June 1, 2021
Estimated Primary Completion Date : January 31, 2026
Estimated Study Completion Date : January 31, 2026

Resource links provided by the National Library of Medicine


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 Name: HOPES




Primary Outcome Measures :
  1. Change in Social Adjustment Scale II [ Time Frame: Measurement at 0, 6, 12, 18, 24 months ]
    Measure of social functioning

  2. Change in Heinrich Quality of Life Scale [ Time Frame: Measurement at 0, 6, 12, 18, 24 months ]
    Measure of social functioning

  3. Change in Social Skills Performance Assessment [ Time Frame: Measurement at 0, 6, 12, 18, 24 months ]
    Measure of social functioning using role played scenarios


Secondary Outcome Measures :
  1. Change in Auditory Verbal Learning Test [ Time Frame: Measurement at 0, 6, 12, 18, 24 months ]
    Neurocognition measure of verbal ability in NIH Toolbox

  2. Change in List Sorting Working Memory [ Time Frame: Measurement at 0, 6, 12, 18, 24 months ]
    Neurocognition measure of working memory in NIH Toolbox

  3. 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

  4. 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

  5. Change in Picture Vocabulary [ Time Frame: Measurement at 0, 6, 12, 18, 24 months ]
    Neurocognition measure of language in NIH Toolbox

  6. Change in Oral Reading Recognition [ Time Frame: Measurement at 0, 6, 12, 18, 24 months ]
    Neurocognition measure of language in NIH Toolbox

  7. Change in Penn Mouse Practice Test [ Time Frame: Measurement at 0, 6, 12, 18, 24 months ]
    Neurocognition measure of speed of processing in PennCNB

  8. Change in Penn Digit Symbol Test [ Time Frame: Measurement at 0, 6, 12, 18, 24 months ]
    Neurocognition measure of speed of processing in PennCNB

  9. Change in Penn Conditional Exclusion Test [ Time Frame: Measurement at 0, 6, 12, 18, 24 months ]
    Neurocognition measure of reasoning & problem solving in PennCNB

  10. Change in Penn Continuous Performance Test [ Time Frame: Measurement at 0, 6, 12, 18, 24 months ]
    Neurocognition measure of reasoning & problem solving in PennCNB

  11. Change in Managing Emotions [ Time Frame: Measurement at 0, 6, 12, 18, 24 months ]
    Subscale of the Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04321759


Contacts
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Contact: Jennifer Sabbagh 617-975-8545 ext 58545 jsabbagh@bidmc.harvard.edu
Contact: Blanche Spindell 617-735-4261 bspindel@bidmc.harvard.edu

Locations
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United States, Connecticut
Hartford Hospital - Institute of Living Recruiting
Hartford, Connecticut, United States, 06106
Contact: Jimmy Choi, PsyD         
United States, Maine
Maine Medical Center Recruiting
Portland, Maine, United States, 04102
Contact: Kristen Woodberry, MSW, PhD         
United States, Massachusetts
Massachusetts Mental Health Center Recruiting
Boston, Massachusetts, United States, 02115
Contact: Fred Crow, MD         
Beth Israel Deaconess Medical Center Active, not recruiting
Boston, Massachusetts, United States, 02215
UMass Medical School Recruiting
Worcester, Massachusetts, United States, 01603
Contact: Xaioduo Fan, MD, MPH         
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: Matcheri S Keshavan, MD Beth Israel Deaconess Medical Center
Principal Investigator: Russell K Schutt, PhD Beth Israel Deaconess Medical Center
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Responsible Party: Matcheri S. Keshavan MD, Stanley Cobb Professor and Academic Head of Psychiatry, Department of Psychiatry,, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT04321759    
Other Study ID Numbers: 2020P000094
CER-2018C3-14701 ( Other Grant/Funding Number: PCORI )
First Posted: March 25, 2020    Key Record Dates
Last Update Posted: April 8, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Matcheri S. Keshavan MD, Beth Israel Deaconess Medical Center:
Cognitive functioning
Social skills
Community functioning
Additional relevant MeSH terms:
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Schizophrenia
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders