Effectiveness of Behavioral Activation Treatment for Schizophrenia

Negative Symptoms in Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05764148
• Other study ID #: 2021-01-026
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2023
• Source: Inha University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Behavioral Activation
• Schizophrenia
• Schizotypal Personality Disorder

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Inha university hospital	Incheon	Jung-Gu

Sponsors (1)

Lead Sponsor	Collaborator
Inha University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	negative function	improved negative function	three month
Secondary	cognitive function	improved cognitive function	three month
Secondary	depressed mood	improved depressed mood	three month