Effectiveness of Behavioral Activation Treatment for Schizophrenia

Study Overview
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Brief Summary
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The purpose of this study is to implement a behavior activation remote program for negative symptoms of schizophrenia and to verify whether the behavior activation remote program for negative symptoms of schizophrenia has effects on negative symptoms, cognitive function, and social function of schizophrenia.

Official Title
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Effectiveness of Non Face-to-face Behavioral Activation Treatment for Negative Symptoms of Schizophrenia

Conditions
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Schizophrenia, Latent, Negative Symptoms in Schizophrenia, Behavioral Activation, Remote Medical Service

Intervention / Treatment
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* Behavioral: behavioral activation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who have received a primary diagnosis of schizophrenia Patients who are at least 18 years old and under 65 years old Patients who show a score of 3 or higher on at least two negative symptom items in the Positive and Negative Syndrome Scale (PANSS) The subject selection period is until December 31, 2021, from the IRB approval date. Exclusion Criteria: Patients with a history of organic brain syndrome, epilepsy, or traumatic brain injury Patients with comorbidities such as intellectual disability, current alcohol or other substance dependence Patients who show a score of 5 or higher on at least two positive symptom items in the Positive and Negative Syndrome Scale (PANSS) Patients who have received a diagnosis of major depressive disorder according to the DSM-V criteria by a specialist in psychiatry Patients who have received psychological services including components of behavioral activation therapy Patients who are at risk of self-harm or harm to others.

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: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: schizophrenia group and treatment as usual
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Behavioral activation<br>Behavioral activation | Behavioral: behavioral activation<br>* Behavioral Activation (BA) is a specific CBT skill. It can be a treatment all by itself, or can be used alongside other CBT skills such as cognitive restructuring. Behavioral activation helps us understand how behaviors influence emotions, just like cognitive work helps us understand the connection between thoughts and emotions.<br>|
| Placebo Comparator: Traatment as usual<br> | Behavioral: behavioral activation<br>* Behavioral Activation (BA) is a specific CBT skill. It can be a treatment all by itself, or can be used alongside other CBT skills such as cognitive restructuring. Behavioral activation helps us understand how behaviors influence emotions, just like cognitive work helps us understand the connection between thoughts and emotions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| negative function | improved negative function | three month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cognitive function | improved cognitive function | three month | 
| depressed mood | improved depressed mood | three month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Schizophrenia, Negative Symptoms in Schizophrenia, behavioral activation, Remote Medical Service