Schizophrenia, LatentNCT05764148
Effectiveness of Behavioral Activation Treatment for Schizophrenia
A study testing behavioral activation in people with Schizophrenia, Latent and Negative Symptoms in Schizophrenia, run by Inha University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Latent, Negative Symptoms in Schizophrenia, Behavioral Activation
- What is being tested?
- behavioral activation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Mar 2021to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Inha university hospital
Incheon, Jung-Gu, 22332
Wonhyoung Kim, PhD, 82-32-890-3639, ckgodman@gmail.com
About this study
Official title: 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.
- Conditions
- Schizophrenia, Latent, Negative Symptoms in Schizophrenia, Behavioral Activation, Remote Medical Service
- Being tested
- behavioral activation
- Keywords
- Schizophrenia, Negative Symptoms in Schizophrenia, behavioral activation, Remote Medical Service
- Medical subject headings
- Schizotypal Personality Disorder, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
behavioral activationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral activation | Experimental | Behavioral activation Receives: Behavioral: behavioral activation |
| Traatment as usual | Placebo comparator | Not described Receives: Behavioral: behavioral activation |
What is being measured
The primary outcome is the main question the study is designed to answer.
negative function
improved negative function
Measured: three month
Secondary outcomes (2)
cognitive function
improved cognitive function
Measured: three month
depressed mood
improved depressed mood
Measured: three month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2023
- Study start1 Mar 2021
- Primary completion1 Sep 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Schizophrenia, LatentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- schizophrenia group and treatment as usual
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inha University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wonhyoung Kim, Inha University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05764148
- Sponsor's protocol ID
- 2021-01-026
- Status last verified
- Mar 2023
- First submitted
- 1 Mar 2023
- Last updated
- 10 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim WH, Kim HS, Lee TJ, Koo HJ. Effectiveness of Non-Face-to-Face Behavioral Activation Treatment for Negative Symptoms of Schizophrenia: A Prospective, Non-Randomized Study. Psychiatry Investig. 2026 Mar;23(3):308-320. doi: 10.30773/pi.2025.0075. Epub 2026 Mar 6.
PubMed 41850253
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Non Face-to-face Behavioral Activation Treatment for Negative Symptoms of Schizophrenia
- ClinicalTrials.gov ID
- NCT05764148
- Acronym / sponsor ID
- 2021-01-026
- Conditions
- Schizophrenia, Latent, Negative Symptoms in Schizophrenia, Behavioral Activation, Remote Medical Service
- Keywords
- Schizophrenia, Negative Symptoms in Schizophrenia, behavioral activation, Remote Medical Service
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Inha University HospitalUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 10 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- schizophrenia group and treatment as usual
| Arm | Type | Receives |
|---|---|---|
| Behavioral activation | Experimental | Behavioral: behavioral activationBehavioral activation |
| Traatment as usual | Placebo comparator | Behavioral: behavioral activation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| behavioral activationBehavioral 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. | Behavioural | Behavioral activation, Traatment as usual |
Primary outcome
negative function
Time frame: three month
improved negative function
2 secondary outcomes
cognitive function
Time frame: three month
depressed mood
Time frame: three month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2023.
- Derived from this study: PubMed 41850253Kim WH, Kim HS, Lee TJ, Koo HJ. Effectiveness of Non-Face-to-Face Behavioral Activation Treatment for Negative Symptoms of Schizophrenia: A Prospective, Non-Randomized Study. Psychiatry Investig. 2026 Mar;23(3):308-320. doi: 10.30773/pi.2025.0075. Epub 2026 Mar 6.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing behavioral activation in people with Schizophrenia, Latent and Negative Symptoms in Schizophrenia, run by Inha University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
negative function (time frame: three month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05764148, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2023.