Effectiveness of Behavioral Activation Treatment for Schizophrenia

NCT05764148 | Unknown DMC

• 1 other identifier: 2021-01-026
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Schizophrenia; Negative Symptoms in Schizophrenia; behavioral activation; Remote Medical Service

Outcome Measures

Primary Outcomes (1)

• negative function

  improved negative function

  three month

Secondary Outcomes (2)

• cognitive function

  three month

• depressed mood

  three month

Study Arms (2)

Behavioral activation

EXPERIMENTAL

Behavioral activation

Behavioral: behavioral activation

Traatment as usual

PLACEBO COMPARATOR

Behavioral: behavioral activation

Interventions

behavioral activation BEHAVIORAL

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.

Behavioral activation; Traatment as usual

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Inha University Hospital: lead

Study Sites (1)

Inha university hospital

Incheon, Jung-Gu, 22332, South Korea

RECRUITING

MeSH Terms

Conditions

Schizotypal Personality Disorder; Schizophrenia

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated professor

Model Details: schizophrenia group and treatment as usual

Study Record Dates

• First Submitted: March 1, 2023
• First Posted: March 10, 2023
• Study Start: March 1, 2021
• Primary Completion: September 1, 2023
• Study Completion: December 31, 2023
• Last Updated: March 10, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)