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

Not Applicable

Completed

• Conditions: Schizophrenia

• 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
• Primary Completion: 2025-05-31
• Study Completion: 2025-05-31
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-07
• Last Update Posted: 2025-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 134

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

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