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OpenTrials
Completed

NCT Number: NCT05282186

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

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.

Other names: HOPES

Primary outcomes

  1. Change in Social Adjustment Scale II

    Time frame: Measurement at 0, 6, 12 months

    Measure of ability to engage socially in community settings

  2. Change in Heinrich Quality of Life Scale

    Time frame: Measurement at 0, 6, 12 months

    Measure of quality of life

  3. Change in Social Skills Performance Assessment rating scale

    Time frame: Measurement at 0, 6, 12 months

    Social skills measure using role plays

Secondary outcomes

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

    Time frame: Measurement at 0, 6, 12 months

    Neurocognition

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

    Time frame: Measurement at 0, 6, 12 months

    Social cognition

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Mar 16, 2022
Registry last updated
Jul 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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