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

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 Overview

• Status: Unknown
• Conditions: HIV Infections
• Intervention / Treatment: Behavioral: Cognitive Behavioral Therapy

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 120-752
    • Division of Infectious Diseases, Department of Internal Medicine, Severance Hospital, Yonsei University Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life	Individual patient would be measured by PozQoL. PozQoL is a tool measuring quality of life among people with HIV.	1 year

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2019
• Primary Completion (Anticipated): January 31, 2020
• Study Completion (Anticipated): February 29, 2020

Study Registration Dates

• First Submitted: January 22, 2019
• First Submitted That Met QC Criteria: January 27, 2019
• First Posted (Actual): January 30, 2019

Study Record Updates

• Last Update Posted (Actual): January 30, 2019
• Last Update Submitted That Met QC Criteria: January 27, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: 4-2018-0755

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No