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

Study Overview
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Brief Summary
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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.

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

Conditions
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Schizophrenia

Intervention / Treatment
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* Behavioral: Cognitive Enhancement Therapy
* Behavioral: Social Skills Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18 to 65; DSM-5 diagnosis of schizophrenia or schizoaffective or schizophreniform disorder Exclusion Criteria: the presence of a current organic brain syndrome; a current and severe substance use disorder (DSM-5); intellectual disability (DSM-5)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized cluster design with 19 service centers assigned to one of the two treatments.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive Enhancement Therapy<br>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<br>* 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.<br>|
| Active Comparator: Social Skills Training<br>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<br>* 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.<br>* Other names: HOPES;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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reward, olfaction