NCT04321759

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
378

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 25, 2020

Completed
1.2 years until next milestone

Study Start

First participant enrolled

June 1, 2021

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2026

Completed
Last Updated

November 14, 2023

Status Verified

November 1, 2023

Enrollment Period

4.7 years

First QC Date

March 18, 2020

Last Update Submit

November 13, 2023

Conditions

Schizophrenia and Related Disorders

Keywords

Cognitive functioningSocial skillsCommunity functioning

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (11)

  • Change in Auditory Verbal Learning Test

    Measurement at 0, 6, 12, 18, 24 months

  • Change in List Sorting Working Memory

    Measurement at 0, 6, 12, 18, 24 months

  • Change in Positive and Negative Syndrome Scale, PANSS-6

    Measurement at 0, 6, 12, 18, 24 months

  • Change in Picture Sequence Memory

    Measurement at 0, 6, 12, 18, 24 months

  • Change in Picture Vocabulary

    Measurement at 0, 6, 12, 18, 24 months

  • +6 more secondary outcomes

Study Arms (2)

Cognitive Enhancement Therapy

EXPERIMENTAL

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

Social Skills Training

ACTIVE COMPARATOR

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

Interventions

Cognitive Enhancement TherapyBEHAVIORAL

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.

Cognitive Enhancement Therapy
Social Skills TrainingBEHAVIORAL

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.

Also known as: HOPES
Social Skills Training

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • the presence of a current organic brain syndrome;
  • intellectual disability (DSM-5);
  • participation in either CET or SST within the prior year.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Hartford Hospital - Institute of Living

Hartford, Connecticut, 06106, United States

RECRUITING

Maine Medical Center

Portland, Maine, 04102, United States

RECRUITING

Massachusetts Mental Health Center

Boston, Massachusetts, 02115, United States

RECRUITING

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

ACTIVE NOT RECRUITING

UMass Medical School

Worcester, Massachusetts, 01603, United States

RECRUITING

Related 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 evaluation. BMC Psychiatry. 2022 Sep 1;22(1):583. doi: 10.1186/s12888-022-04149-x.

    PMID: 36050663RESULT

Related Links

MeSH Terms

Conditions

SchizophreniaSocial Skills

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersSocial BehaviorBehavior

Study Officials

  • Matcheri S Keshavan, MD

    Beth Israel Deaconess Medical Center

    PRINCIPAL INVESTIGATOR

  • Russell K Schutt, PhD

    Beth Israel Deaconess Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Sabbagh

CONTACT

617-975-8545jsabbagh@bidmc.harvard.edu

Blanche Spindell

CONTACT

617-735-4261bspindel@bidmc.harvard.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized cluster design with 19 service centers assigned to one of the two treatments.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Stanley Cobb Professor and Academic Head of Psychiatry, Department of Psychiatry,

Study Record Dates

First Submitted

March 18, 2020

First Posted

March 25, 2020

Study Start

June 1, 2021

Primary Completion

January 31, 2026

Study Completion

January 31, 2026

Last Updated

November 14, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

US(5)