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

Not Applicable

Recruiting

• Conditions: Schizophrenia
• Interventions: Behavioral: Social Skills Training; Behavioral: Cognitive Enhancement Therapy

• Registration Number: NCT05282186
• Lead Sponsor: Beth Israel Deaconess Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-02
• Study First Submitted QC: 2022-03-09
• Study First Posted: 2022-03-16
• Study Start: 2022-09-02
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-27
• Last Update Posted: 2024-03-29
• Primary Completion: 2025-02-28
• Study Completion: 2025-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 116

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Social Skills Training	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.
Cognitive Enhancement Therapy	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.

Primary Outcome Measures

Name	Time	Method
Change in Social Skills Performance Assessment rating scale	Measurement at 0, 6, 12 months	Social skills measure using role plays
Change in Social Adjustment Scale II	Measurement at 0, 6, 12 months	Measure of ability to engage socially in community settings
Change in Heinrich Quality of Life Scale	Measurement at 0, 6, 12 months	Measure of quality of life

Secondary Outcome Measures

Name	Time	Method
Change in NIH Toolbox® for Assessment of Neurological and Behavioral Function (NIH Toolbox)	Measurement at 0, 6, 12 months	Neurocognition
Change in Managing Emotions subscale of the Meyer-Salovey-Caruso Emotional Intelligence Test (MSCEIT)	Measurement at 0, 6, 12 months	Social cognition

Trial Locations

Locations (1)

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States