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Psychosocial Interventions for Schizophrenia

N/A

Recruiting

Research Sponsored by Beth Israel Deaconess Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 to 65

DSM-5 diagnosis of schizophrenia or schizoaffective or schizophreniform disorder

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measurement at 0, 6, 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trialwill measure how smell affects mental health treatment for people with schizophrenia, to better tailor interventions and help improve outcomes.

Who is the study for?

This trial is for individuals aged 18 to 65 with a diagnosis of schizophrenia, schizoaffective, or schizophreniform disorder. It's not suitable for those with severe substance use disorders, intellectual disabilities, or organic brain syndromes as per DSM-5 criteria.

What is being tested?

The study aims to see if a person's sense of smell can predict who will benefit from social skills training and cognitive enhancement therapy in treating schizophrenia.

What are the potential side effects?

Since the interventions are psychosocial rather than medical treatments like drugs or surgery, they may include discomfort during therapy sessions but do not have physical side effects typical of medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 65 years old.

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I have been diagnosed with schizophrenia or a related disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measurement at 0, 6, 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measurement at 0, 6, 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and measurement at 0, 6, 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Heinrich Quality of Life Scale

Change in Social Adjustment Scale II

Change in Social Skills Performance Assessment rating scale

Secondary study objectives

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

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Cognitive Enhancement TherapyExperimental Treatment1 Intervention

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.

Group II: Social Skills TrainingActive Control1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cognitive Enhancement Therapy

2012

N/A

~160

0 / 2Eligibility criteria met