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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05282186
Enrollment
134
Registered
2022-03-16
Start date
2022-09-02
Completion date
2025-05-31
Last updated
2025-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

olfaction, reward

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.

Interventions

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.

BEHAVIORALSocial Skills Training

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.

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
Beth Israel Deaconess Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Intervention model description

Randomized cluster design with 19 service centers assigned to one of the two treatments.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Change in Social Adjustment Scale IIMeasurement at 0, 6, 12 monthsMeasure of ability to engage socially in community settings
Change in Heinrich Quality of Life ScaleMeasurement at 0, 6, 12 monthsMeasure of quality of life
Change in Social Skills Performance Assessment rating scaleMeasurement at 0, 6, 12 monthsSocial skills measure using role plays

Secondary

MeasureTime frameDescription
Change in NIH Toolbox® for Assessment of Neurological and Behavioral Function (NIH Toolbox)Measurement at 0, 6, 12 monthsNeurocognition
Change in Managing Emotions subscale of the Meyer-Salovey-Caruso Emotional Intelligence Test (MSCEIT)Measurement at 0, 6, 12 monthsSocial cognition

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026