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

NCT05282186 | Completed

• 2 other identifiers: 2022P000199R21MH127479-01A1
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Keywords

olfaction; reward

Outcome Measures

Primary Outcomes (3)

• Change in Social Adjustment Scale II

  Measure of ability to engage socially in community settings

  Measurement at 0, 6, 12 months

• Change in Heinrich Quality of Life Scale

  Measure of quality of life

  Measurement at 0, 6, 12 months

• Change in Social Skills Performance Assessment rating scale

  Social skills measure using role plays

  Measurement at 0, 6, 12 months

Secondary Outcomes (2)

• Change in NIH Toolbox® for Assessment of Neurological and Behavioral Function (NIH Toolbox)

  Measurement at 0, 6, 12 months

• Change in Managing Emotions subscale of the Meyer-Salovey-Caruso Emotional Intelligence Test (MSCEIT)

  Measurement at 0, 6, 12 months

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 Therapy BEHAVIORAL

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 Training BEHAVIORAL

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

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 18 to 65;
• DSM-5 diagnosis of schizophrenia or schizoaffective or schizophreniform disorder

You may not qualify if:

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

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Schizophrenia; Anosmia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Olfaction Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychology

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

Study Record Dates

• First Submitted: March 2, 2022
• First Posted: March 16, 2022
• Study Start: September 2, 2022
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: July 10, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)