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

Primary Purpose

Schizophrenia and Related Disorders

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Enhancement Therapy
Social Skills Training
Sponsored by
Beth Israel Deaconess Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia and Related Disorders focused on measuring Cognitive functioning, Social skills, Community functioning

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hartford Hospital - Institute of LivingRecruiting
  • Maine Medical CenterRecruiting
  • Massachusetts Mental Health CenterRecruiting
  • Beth Israel Deaconess Medical Center
  • UMass Medical SchoolRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cognitive Enhancement Therapy

Social Skills Training

Arm Description

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.

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..

Outcomes

Primary Outcome Measures

Change in Social Adjustment Scale II
Measure of social functioning
Change in Heinrich Quality of Life Scale
Measure of social functioning
Change in Social Skills Performance Assessment
Measure of social functioning using role played scenarios

Secondary Outcome Measures

Change in Auditory Verbal Learning Test
Neurocognition measure of verbal ability in NIH Toolbox
Change in List Sorting Working Memory
Neurocognition measure of working memory in NIH Toolbox
Change in Positive and Negative Syndrome Scale, PANSS-6
Short form of measure of positive and negative symptoms
Change in Picture Sequence Memory
Neurocognition measure of visual/episodic memory & learning in NIH Toolbox
Change in Picture Vocabulary
Neurocognition measure of language in NIH Toolbox
Change in Oral Reading Recognition
Neurocognition measure of language in NIH Toolbox
Change in Penn Mouse Practice Test
Neurocognition measure of speed of processing in PennCNB
Change in Penn Digit Symbol Test
Neurocognition measure of speed of processing in PennCNB
Change in Penn Conditional Exclusion Test
Neurocognition measure of reasoning & problem solving in PennCNB
Change in Penn Continuous Performance Test
Neurocognition measure of reasoning & problem solving in PennCNB
Change in Managing Emotions
Subscale of the Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT)

Full Information

First Posted
March 18, 2020
Last Updated
March 31, 2022
Sponsor
Beth Israel Deaconess Medical Center
Collaborators
Patient-Centered Outcomes Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04321759
Brief Title
Comparative Effectiveness of CET vs. SST in SMI (Serious Mental Illness)
Official Title
Comparative Effectiveness of Cognitive Enhancement Therapy vs. Social Skills Training in Serious Mental Illness
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
January 31, 2026 (Anticipated)
Study Completion Date
January 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center
Collaborators
Patient-Centered Outcomes Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia and Related Disorders
Keywords
Cognitive functioning, Social skills, Community functioning

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized cluster design with 19 service centers assigned to one of the two treatments.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
378 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Enhancement Therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Social Skills Training
Arm Type
Active Comparator
Arm Description
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..
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Enhancement Therapy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Social Skills Training
Other Intervention Name(s)
HOPES
Intervention Description
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 Information:
Title
Change in Social Adjustment Scale II
Description
Measure of social functioning
Time Frame
Measurement at 0, 6, 12, 18, 24 months
Title
Change in Heinrich Quality of Life Scale
Description
Measure of social functioning
Time Frame
Measurement at 0, 6, 12, 18, 24 months
Title
Change in Social Skills Performance Assessment
Description
Measure of social functioning using role played scenarios
Time Frame
Measurement at 0, 6, 12, 18, 24 months
Secondary Outcome Measure Information:
Title
Change in Auditory Verbal Learning Test
Description
Neurocognition measure of verbal ability in NIH Toolbox
Time Frame
Measurement at 0, 6, 12, 18, 24 months
Title
Change in List Sorting Working Memory
Description
Neurocognition measure of working memory in NIH Toolbox
Time Frame
Measurement at 0, 6, 12, 18, 24 months
Title
Change in Positive and Negative Syndrome Scale, PANSS-6
Description
Short form of measure of positive and negative symptoms
Time Frame
Measurement at 0, 6, 12, 18, 24 months
Title
Change in Picture Sequence Memory
Description
Neurocognition measure of visual/episodic memory & learning in NIH Toolbox
Time Frame
Measurement at 0, 6, 12, 18, 24 months
Title
Change in Picture Vocabulary
Description
Neurocognition measure of language in NIH Toolbox
Time Frame
Measurement at 0, 6, 12, 18, 24 months
Title
Change in Oral Reading Recognition
Description
Neurocognition measure of language in NIH Toolbox
Time Frame
Measurement at 0, 6, 12, 18, 24 months
Title
Change in Penn Mouse Practice Test
Description
Neurocognition measure of speed of processing in PennCNB
Time Frame
Measurement at 0, 6, 12, 18, 24 months
Title
Change in Penn Digit Symbol Test
Description
Neurocognition measure of speed of processing in PennCNB
Time Frame
Measurement at 0, 6, 12, 18, 24 months
Title
Change in Penn Conditional Exclusion Test
Description
Neurocognition measure of reasoning & problem solving in PennCNB
Time Frame
Measurement at 0, 6, 12, 18, 24 months
Title
Change in Penn Continuous Performance Test
Description
Neurocognition measure of reasoning & problem solving in PennCNB
Time Frame
Measurement at 0, 6, 12, 18, 24 months
Title
Change in Managing Emotions
Description
Subscale of the Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT)
Time Frame
Measurement at 0, 6, 12, 18, 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age 18 to 65; DSM-5 diagnosis of schizophrenia or schizoaffective or schizophreniform disorder (confirmed via the MINI diagnostic interview); estimated IQ of > 70 (established via WTAR). Exclusion Criteria: the presence of a current organic brain syndrome; intellectual disability (DSM-5); participation in either CET or SST within the prior year.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Sabbagh
Phone
617-975-8545
Ext
58545
Email
jsabbagh@bidmc.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Blanche Spindell
Phone
617-735-4261
Email
bspindel@bidmc.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matcheri S Keshavan, MD
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Russell K Schutt, PhD
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hartford Hospital - Institute of Living
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jimmy Choi, PsyD
Facility Name
Maine Medical Center
City
Portland
State/Province
Maine
ZIP/Postal Code
04102
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristen Woodberry, MSW, PhD
Facility Name
Massachusetts Mental Health Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fred Crow, MD
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
UMass Medical School
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01603
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xaioduo Fan, MD, MPH

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36050663
Citation
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.
Results Reference
derived

Learn more about this trial

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

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