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

Primary Purpose

HIV Infections

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for HIV Infections

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Division of Infectious Diseases, Department of Internal Medicine, Severance Hospital, Yonsei University Health System

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CBT

Arm Description

Outcomes

Primary Outcome Measures

Level of depression
Individual patient would be measured by Beck depression inventory.
Level of adherence
Individual patient would be measured by visual analog scale and pill counting.

Secondary Outcome Measures

Quality of life
Individual patient would be measured by PozQoL. PozQoL is a tool measuring quality of life among people with HIV.

Full Information

First Posted
January 22, 2019
Last Updated
January 27, 2019
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT03823261
Brief Title
Effects of a Nurse-delivered Cognitive Behaviour Therapy on Adherence and Depressive Symptoms in HIV Infected Persons of South Korea
Official Title
Effects of a Nurse-delivered Cognitive Behaviour Therapy on Adherence and Depressive Symptoms in HIV Infected Persons of South Korea
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 2019 (Anticipated)
Primary Completion Date
January 31, 2020 (Anticipated)
Study Completion Date
February 29, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective, open-label cohort study without a control, and no blindness.
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CBT
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy
Intervention Description
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 Measure Information:
Title
Level of depression
Description
Individual patient would be measured by Beck depression inventory.
Time Frame
1 year
Title
Level of adherence
Description
Individual patient would be measured by visual analog scale and pill counting.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Quality of life
Description
Individual patient would be measured by PozQoL. PozQoL is a tool measuring quality of life among people with HIV.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: HIV(+) Koreans, using ART Adult (19+ years) Having self-reported depressive symptoms or self-reported adherence<90% Being fluent in Korean Exclusion criteria: 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
Facility Information:
Facility Name
Division of Infectious Diseases, Department of Internal Medicine, Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Yong Choi, MD
Phone
82-2-2228-1974
Email
seran@yuhs.ac

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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