Effectiveness of Behavioral Activation Treatment for Schizophrenia

Sponsor

Inha University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05764148

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia, Latent Negative Symptoms in Schizophrenia Behavioral Activation Remote Medical Service	Behavioral: behavioral activation	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

schizophrenia group and treatment as usualschizophrenia group and treatment as usual

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 1, 2021

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Behavioral activation Behavioral activation	Behavioral: behavioral activation 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.
Placebo Comparator: Traatment as usual	Behavioral: behavioral activation 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.

Arm

Intervention/Treatment

Experimental: Behavioral activation

Behavioral activation

Behavioral: behavioral activation

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.

Placebo Comparator: Traatment as usual

Behavioral: behavioral activation

Outcome Measures

Primary Outcome Measures

negative function [three month]
improved negative function

Secondary Outcome Measures

cognitive function [three month]
improved cognitive function
depressed mood [three month]
improved depressed mood

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.