Clinical Trials

MainTitle

Effects of a Nurse-delivered Cognitive Behaviour Therapy on Adherence and Depressive Symptoms in HIV Infected Persons of South Korea

This study is not yet open for participant recruitment. (see Contacts and Locations)

Verified January 2019 by Yonsei University

Sponsor
Yonsei University


Information provided by (Responsible Party)
Yonsei University
ClinicalTrials.gov Identifier
NCT03823261

First received: January 22, 2019
Last updated: January 27, 2019
Last Verified: January 2019
History of Changes
Purpose

Purpose

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.

Condition Intervention
HIV Infections

Behavioral : Cognitive Behavioral Therapy

Study Type: Interventional
Study Design: Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective, open-label cohort study without a control, and no blindness.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effects of a Nurse-delivered Cognitive Behaviour Therapy on Adherence and Depressive Symptoms in HIV Infected Persons of South Korea

Further study details as provided by Yonsei University:

Primary Outcome Measures

  • 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.
Secondary Outcome Measures:
  • Quality of life [ Time Frame: 1 year ]
    Individual patient would be measured by PozQoL. PozQoL is a tool measuring quality of life among people with HIV.

Estimated Enrollment: 10
Study Start Date: March 2019
Estimated Study Completion Date: February 29, 2020
Estimated Primary Completion Date: January 31, 2020 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: CBT

Behavioral: Cognitive Behavioral Therapy

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

Eligibility

Ages Eligible for Study: 19 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

Inclusion criteria:

    1. HIV(+) Koreans, using ART
    2. Adult (19+ years)
    3. Having self-reported depressive symptoms or self-reported adherence<90%
    4. Being fluent in Korean


Exclusion Criteria:
    1. Suicidal ideation
    2. Active psychosis
    3. Uncontrolled neurological problem
    4. Having been initiated on or had their dose of psychotropic medication altered within the past 3 months
    5. Currently receiving psychotherapy for depression
    6. Having previously received CBT

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03823261

Locations

Korea, Republic of
Division of Infectious Diseases, Department of Internal Medicine, Severance Hospital, Yonsei University Health System
Seoul, Korea, Republic of, 120-752
Contact: Jun Yong Choi, MD    82-2-2228-1974    seran@yuhs.ac

Sponsors and Collaborators

Yonsei University
More Information

More Information


Responsible Party: Yonsei University  
ClinicalTrials.gov Identifier: NCT03823261   History of Changes  
Other Study ID Numbers: 4-2018-0755  
Study First Received: January 22, 2019  
Last Updated: January 27, 2019  
Individual Participant Data    
Plan to Share IPD: No  

Studies a U.S. FDA-regulated Drug Product: No  
Studies a U.S. FDA-regulated Device Product: No  

Additional relevant MeSH terms:
Depression

ClinicalTrials.gov processed this data on June 02, 2020
This information is provided by ClinicalTrials.gov.