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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03823261
Recruitment Status : Not yet recruiting
First Posted : January 30, 2019
Last Update Posted : January 30, 2019
Information provided by (Responsible Party):
Yonsei University

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.

Condition or disease Intervention/treatment Phase
HIV Infections Behavioral: Cognitive Behavioral Therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
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
Estimated Study Start Date : March 2019
Estimated Primary Completion Date : January 31, 2020
Estimated Study Completion Date : February 29, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Level of depression [ Time Frame: 1 year ]
    Individual patient would be measured by Beck depression inventory.

  2. Level of adherence [ Time Frame: 1 year ]
    Individual patient would be measured by visual analog scale and pill counting.

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03823261

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Korea, Republic of
Division of Infectious Diseases, Department of Internal Medicine, Severance Hospital, Yonsei University Health System Not yet recruiting
Seoul, Korea, Republic of, 120-752
Contact: Jun Yong Choi, MD    82-2-2228-1974   
Sponsors and Collaborators
Yonsei University

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Responsible Party: Yonsei University Identifier: NCT03823261     History of Changes
Other Study ID Numbers: 4-2018-0755
First Posted: January 30, 2019    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Behavioral Symptoms