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

• Sponsor: Beth Israel Deaconess Medical Center (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05282186
• Collaborator: National Institute of Mental Health (NIMH) (NIH)
• Enrollment: 116
• Arms: 2
• Anticipated Duration (Months): 24

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Behavioral: Cognitive Enhancement Therapy; Behavioral: Social Skills Training	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 116 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized cluster design with 19 service centers assigned to one of the two treatments.Randomized cluster design with 19 service centers assigned to one of the two treatments.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: What the Nose Knows: Hedonic Capacity, Psychosocial Interventions and Outcomes in Schizophrenia
• Anticipated Study Start Date: Apr 1, 2022
• Anticipated Primary Completion Date: Feb 29, 2024
• Anticipated Study Completion Date: Mar 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Behavioral: Cognitive Enhancement Therapy; 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.
Active Comparator: 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.	Behavioral: Social 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.; Other Names: HOPES

Outcome Measures

Primary Outcome Measures

1. Change in Social Adjustment Scale II [Measurement at 0, 6, 12 months]

   Measure of ability to engage socially in community settings

2. Change in Heinrich Quality of Life Scale [Measurement at 0, 6, 12 months]

   Measure of quality of life

3. Change in Social Skills Performance Assessment rating scale [Measurement at 0, 6, 12 months]

   Social skills measure using role plays

Secondary Outcome Measures

1. Change in NIH Toolbox® for Assessment of Neurological and Behavioral Function (NIH Toolbox) [Measurement at 0, 6, 12 months]

   Neurocognition

2. Change in Managing Emotions subscale of the Meyer-Salovey-Caruso Emotional Intelligence Test (MSCEIT) [Measurement at 0, 6, 12 months]

   Social cognition

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts 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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Raquelle Mesholam-Gately, Assistant Professor of Psychology, Beth Israel Deaconess Medical Center
• ClinicalTrials.gov Identifier: NCT05282186
• Other Study ID Numbers: NIH R21 MH127479-01A1
• First Posted: Mar 16, 2022
• Last Update Posted: Mar 16, 2022
• Last Verified: Mar 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Raquelle Mesholam-Gately, Assistant Professor of Psychology, Beth Israel Deaconess Medical Center: olfaction; reward
• Additional relevant MeSH terms: Schizophrenia

Study Results

No Results Posted as of Mar 16, 2022