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What the Nose Knows: Hedonic Capacity, Psychosocial Interventions and Outcomes in Schizophrenia

Primary Purpose

Schizophrenia

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 focused on measuring olfaction, reward

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

Exclusion Criteria:

  1. the presence of a current organic brain syndrome;
  2. a current and severe substance use disorder (DSM-5);
  3. intellectual disability (DSM-5)

Sites / Locations

  • Beth Israel Deaconess Medical CenterRecruiting

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 ability to engage socially in community settings
Change in Heinrich Quality of Life Scale
Measure of quality of life
Change in Social Skills Performance Assessment rating scale
Social skills measure using role plays

Secondary Outcome Measures

Change in NIH Toolbox® for Assessment of Neurological and Behavioral Function (NIH Toolbox)
Neurocognition
Change in Managing Emotions subscale of the Meyer-Salovey-Caruso Emotional Intelligence Test (MSCEIT)
Social cognition

Full Information

First Posted
March 2, 2022
Last Updated
March 6, 2023
Sponsor
Beth Israel Deaconess Medical Center
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT05282186
Brief Title
What the Nose Knows: Hedonic Capacity, Psychosocial Interventions and Outcomes in Schizophrenia
Official Title
What the Nose Knows: Hedonic Capacity, Psychosocial Interventions and Outcomes in Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 2, 2022 (Actual)
Primary Completion Date
February 29, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

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

5. Study Description

Brief Summary
This project proposes to conduct the first study of the predictive utility of olfactory hedonic measurement for targeted psychosocial rehabilitation in schizophrenia. The information gathered from the project is of considerable public health relevance, in that, through simple, reliable olfactory assessment, it will provide knowledge about which individuals are most likely to benefit from these psychosocial interventions. Such information is crucial for tailoring existing interventions and developing new approaches to optimize outcomes in schizophrenia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
olfaction, reward

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
116 (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 ability to engage socially in community settings
Time Frame
Measurement at 0, 6, 12 months
Title
Change in Heinrich Quality of Life Scale
Description
Measure of quality of life
Time Frame
Measurement at 0, 6, 12 months
Title
Change in Social Skills Performance Assessment rating scale
Description
Social skills measure using role plays
Time Frame
Measurement at 0, 6, 12 months
Secondary Outcome Measure Information:
Title
Change in NIH Toolbox® for Assessment of Neurological and Behavioral Function (NIH Toolbox)
Description
Neurocognition
Time Frame
Measurement at 0, 6, 12 months
Title
Change in Managing Emotions subscale of the Meyer-Salovey-Caruso Emotional Intelligence Test (MSCEIT)
Description
Social cognition
Time Frame
Measurement at 0, 6, 12 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 Exclusion Criteria: the presence of a current organic brain syndrome; a current and severe substance use disorder (DSM-5); intellectual disability (DSM-5)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Blanche Spindell
Phone
617-735-4261
Email
bspindel@bidmc.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Sabbagh
Phone
617-975-8545
Email
jsabbagh@bidmc.harvard.edu
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sunny Lee
Email
slee54@bidmc.harvard.edu

12. IPD Sharing Statement

Learn more about this trial

What the Nose Knows: Hedonic Capacity, Psychosocial Interventions and Outcomes in Schizophrenia

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