Effects of a Nurse-delivered Cognitive Behaviour Therapy on Adherence and Depressive Symptoms in HIV Infected Persons of South Korea
1 other identifier
interventional
10
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable hiv-infections
Started Mar 2019
Shorter than P25 for not_applicable hiv-infections
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 22, 2019
CompletedFirst Posted
Study publicly available on registry
January 30, 2019
CompletedStudy Start
First participant enrolled
March 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 29, 2020
CompletedJanuary 30, 2019
January 1, 2019
11 months
January 22, 2019
January 27, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
Level of depression
Individual patient would be measured by Beck depression inventory.
1 year
Level of adherence
Individual patient would be measured by visual analog scale and pill counting.
1 year
Secondary Outcomes (1)
Quality of life
1 year
Study Arms (1)
CBT
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- HIV(+) Koreans, using ART
- Adult (19+ years)
- Having self-reported depressive symptoms or self-reported adherence\<90%
- Being fluent in Korean
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Division of Infectious Diseases, Department of Internal Medicine, Severance Hospital, Yonsei University Health System
Seoul, 120-752, South Korea
Related Publications (1)
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.
PMID: 36450289DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 22, 2019
First Posted
January 30, 2019
Study Start
March 1, 2019
Primary Completion
January 31, 2020
Study Completion
February 29, 2020
Last Updated
January 30, 2019
Record last verified: 2019-01
Data Sharing
- IPD Sharing
- Will not share