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Effectiveness of Behavioral Activation Treatment for Schizophrenia

Primary Purpose

Schizophrenia, Latent, Negative Symptoms in Schizophrenia, Behavioral Activation

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
behavioral activation
Sponsored by
Inha University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia, Latent focused on measuring Schizophrenia, Negative Symptoms in Schizophrenia, behavioral activation, Remote Medical Service

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Inha university hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Behavioral activation

Traatment as usual

Arm Description

Behavioral activation

Outcomes

Primary Outcome Measures

negative function
improved negative function

Secondary Outcome Measures

cognitive function
improved cognitive function
depressed mood
improved depressed mood

Full Information

First Posted
March 1, 2023
Last Updated
March 1, 2023
Sponsor
Inha University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05764148
Brief Title
Effectiveness of Behavioral Activation Treatment for Schizophrenia
Official Title
Effectiveness of Non Face-to-face Behavioral Activation Treatment for Negative Symptoms of Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Inha University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Latent, Negative Symptoms in Schizophrenia, Behavioral Activation, Remote Medical Service
Keywords
Schizophrenia, Negative Symptoms in Schizophrenia, behavioral activation, Remote Medical Service

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
schizophrenia group and treatment as usual
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Behavioral activation
Arm Type
Experimental
Arm Description
Behavioral activation
Arm Title
Traatment as usual
Arm Type
Placebo Comparator
Intervention Type
Behavioral
Intervention Name(s)
behavioral activation
Intervention Description
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.
Primary Outcome Measure Information:
Title
negative function
Description
improved negative function
Time Frame
three month
Secondary Outcome Measure Information:
Title
cognitive function
Description
improved cognitive function
Time Frame
three month
Title
depressed mood
Description
improved depressed mood
Time Frame
three month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Inha university hospital
City
Incheon
State/Province
Jung-Gu
ZIP/Postal Code
22332
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wonhyoung Kim, PhD
Phone
82-32-890-3639
Email
ckgodman@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effectiveness of Behavioral Activation Treatment for Schizophrenia

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