Effectiveness of Behavioral Activation Treatment for Schizophrenia

March 1, 2023 updated by: Wonhyoung Kim, Inha University Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Jung-Gu
      • Incheon, Jung-Gu, Korea, Republic of, 22332
        • Recruiting
        • Inha University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
negative function
Time Frame: three month
improved negative function
three month

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inha University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Anticipated)

September 1, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

March 1, 2023

First Submitted That Met QC Criteria

March 1, 2023

First Posted (Estimate)

March 10, 2023

Study Record Updates

Last Update Posted (Estimate)

March 10, 2023

Last Update Submitted That Met QC Criteria

March 1, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-01-026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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