HIV InfectionsNCT03823261
Effects of a Nurse-delivered Cognitive Behaviour Therapy on Adherence and Depressive Symptoms in HIV Infected Persons of South Korea
A study testing Cognitive Behavioral Therapy in people with HIV Infections, run by Yonsei University at 1 site in South Korea.
Trial summary
Cognitive behaviour therapy (CBT) has repeatedly been found to effectively treat depression in adult populations, and CBT for adherence and depression (CBT-AD) is an effective treatment for improving depressive symptoms and medication adherence in the context of various chronic health conditions, including… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Cognitive Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2019to 29 Feb 2020
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV(+) Koreans, using ART
- Adult (19+ years)
- Having self-reported depressive symptoms or self-reported adherence<90%
- Being fluent in Korean
Who cannot join
- Suicidal ideation
- Active psychosis
- Uncontrolled neurological problem
- Having been initiated on or had their dose of psychotropic medication altered within the past 3 months
- Currently receiving psychotherapy for depression
- Having previously received CBT
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Division of Infectious Diseases, Department of Internal Medicine, Severance Hospital, Yonsei University Health System
Seoul, 120-752
Jun Yong Choi, MD, 82-2-2228-1974, seran@yuhs.ac
About this study
Cognitive behaviour therapy (CBT) has repeatedly been found to effectively treat depression in adult populations, and CBT for adherence and depression (CBT-AD) is an effective treatment for improving depressive symptoms and medication adherence in the context of various chronic health conditions, including HIV-infection. However, the effects of CBT have not been evaluated in South Korea. Even though HIV infection is currently a controllable disease for patients on successful antiretroviral therapy, people living with HIV (PLWH) are still suffering from internal and external stigmatization in many Asian countries, including South Korea. It is not clear whether CBP-AD would be successful intervention among Asian countries with cultural background of strong stigmatization on HIV/AIDS. We plan to do survey on facilitators or barriers to patients and providers to identify significant contextual factors in South Korea. Demographic data and clinical data including CD4+ T cell counts, viral loads, and antiretroviral therapy regimens will be collected, as well.
Specialists such as psychiatrist or clinical psychologist would be the best provider for CBT intervention. However, an effective and feasible therapy model should be integrated into primary HIV care in South Korea. Medical personnel within most HIV clinics in South Korea include infectious diseases doctors, clinical nurses, and counselling nurses, but CBT services from psychiatrist or clinical psychologist are not routinely available in many hospitals. Hospital-based counselling services with experienced nurses have been provided in many HIV clinics in South Korea, and the counselling nurses would be feasible providers for CBT intervention of this study. So, we plan to investigate the effects of a nurse-delivered cognitive behaviour therapy.
- Conditions
- HIV Infections
- Being tested
- Cognitive Behavioral Therapy
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral TherapyBehavioural
HIV(+) Koreans with depressive symptoms or poor adherence are our target population. This study is a hospital based implementation research. Most PLWH in South Korea regularly visit ID clinics in tertiary hospitals. The ID clinic of study site can reach the target population. In the clinic, the levels of adherence are routinely measured, and depressive symptoms will be asked with key questions We plan to enroll 50 subjects for CBT-AD intervention. In addition, 2 nurses who providing CBT service, and 6 health care workers will be enrolled for survey for providers and healthcare workers.
| Study group | Role | What they receive |
|---|---|---|
| CBT | Experimental | Not described Receives: Behavioral: Cognitive Behavioral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of depression
Individual patient would be measured by Beck depression inventory.
Measured: 1 year
Level of adherence
Individual patient would be measured by visual analog scale and pill counting.
Measured: 1 year
Secondary outcomes (1)
Quality of life
Individual patient would be measured by PozQoL. PozQoL is a tool measuring quality of life among people with HIV.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2019
- Study startMar 2019 (estimated)
- Primary completion31 Jan 2020 (estimated)
- Study completion29 Feb 2020 (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 HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, open-label cohort study without a control, and no blindness.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03823261
- Sponsor's protocol ID
- 4-2018-0755
- Status last verified
- Jan 2019
- First submitted
- 22 Jan 2019
- Last updated
- 30 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim JH, Kim JM, Ye M, Lee JI, Na S, Lee Y, Short D, Choi JY. Implementation of a Nurse-Delivered Cognitive Behavioral Therapy for Adherence and Depression of People Living with HIV in Korea. Infect Chemother. 2022 Dec;54(4):733-743. doi: 10.3947/ic.2022.0118. Epub 2022 Nov 11.
PubMed 36450289
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Nurse-delivered Cognitive Behaviour Therapy on Adherence and Depressive Symptoms in HIV Infected Persons of South Korea
- ClinicalTrials.gov ID
- NCT03823261
- Acronym / sponsor ID
- 4-2018-0755
- Conditions
- HIV Infections
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Mar 2019 (estimated)
- Primary completion
- 31 Jan 2020 (estimated)
- Study completion
- 29 Feb 2020 (estimated)
- First posted
- 30 Jan 2019 (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.
Cognitive behaviour therapy (CBT) has repeatedly been found to effectively treat depression in adult populations, and CBT for adherence and depression (CBT-AD) is an effective treatment for improving depressive symptoms and medication adherence in the context of various chronic health conditions, including HIV-infection. However, the effects of CBT have not been evaluated in South Korea. Even though HIV infection is currently a controllable disease for patients on successful antiretroviral therapy, people living with HIV (PLWH) are still suffering from internal and external stigmatization in many Asian countries, including South Korea. It is not clear whether CBP-AD would be successful intervention among Asian countries with cultural background of strong stigmatization on HIV/AIDS. We plan to do survey on facilitators or barriers to patients and providers to identify significant contextual factors in South Korea. Demographic data and clinical data including CD4+ T cell counts, viral loads, and antiretroviral therapy regimens will be collected, as well.
Specialists such as psychiatrist or clinical psychologist would be the best provider for CBT intervention. However, an effective and feasible therapy model should be integrated into primary HIV care in South Korea. Medical personnel within most HIV clinics in South Korea include infectious diseases doctors, clinical nurses, and counselling nurses, but CBT services from psychiatrist or clinical psychologist are not routinely available in many hospitals. Hospital-based counselling services with experienced nurses have been provided in many HIV clinics in South Korea, and the counselling nurses would be feasible providers for CBT intervention of this study. So, we plan to investigate the effects of a nurse-delivered cognitive behaviour therapy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, open-label cohort study without a control, and no blindness.
| Arm | Type | Receives |
|---|---|---|
| CBT | Experimental | Behavioral: Cognitive Behavioral Therapy |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- HIV(+) Koreans, using ART
- Adult (19+ years)
- Having self-reported depressive symptoms or self-reported adherence<90%
- Being fluent in Korean
Key exclusion criteria (6 listed)
- Suicidal ideation
- Active psychosis
- Uncontrolled neurological problem
- Having been initiated on or had their dose of psychotropic medication altered within the past 3 months
- Currently receiving psychotherapy for depression
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 |
|---|---|---|
| Cognitive Behavioral TherapyHIV(+) Koreans with depressive symptoms or poor adherence are our target population. This study is a hospital based implementation research. Most PLWH in South Korea regularly visit ID clinics in tertiary hospitals. The ID clinic of study site can reach the target population. In the clinic, the levels of adherence are routinely measured, and depressive symptoms will be asked with key questions We plan to enroll 50 subjects for CBT-AD intervention. In addition, 2 nurses who providing CBT service, and 6 health care workers will be enrolled for survey for providers and healthcare workers. | Behavioural | CBT |
Primary outcome
Level of depression
Time frame: 1 year
Individual patient would be measured by Beck depression inventory.
Level of adherence
Time frame: 1 year
Individual patient would be measured by visual analog scale and pill counting.
1 secondary outcome
Quality of life
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2019.
- Derived from this study: PubMed 36450289Kim JH, Kim JM, Ye M, Lee JI, Na S, Lee Y, Short D, Choi JY. Implementation of a Nurse-Delivered Cognitive Behavioral Therapy for Adherence and Depression of People Living with HIV in Korea. Infect Chemother. 2022 Dec;54(4):733-743. doi: 10.3947/ic.2022.0118. Epub 2022 Nov 11.
- Individual participant dataSharing planned: No
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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.
Division of Infectious Diseases, Department of Internal Medicine, Severance Hospital, Yonsei University Health System
Seoul, South Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy in people with HIV Infections, run by Yonsei University 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 30 Jan 2019. 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. 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?
Level of depression (time frame: 1 year). The study lists 2 primary outcomes in all. 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 NCT03823261, 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 30 Jan 2019.