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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03823261
• Other study ID #: 4-2018-0755
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2019
• Est. completion date: February 29, 2020

Study information

• Verified date: January 2019
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: February 29, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• HIV Infections

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Division of Infectious Diseases, Department of Internal Medicine, Severance Hospital, Yonsei University Health System	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of depression	Individual patient would be measured by Beck depression inventory.	1 year
Primary	Level of adherence	Individual patient would be measured by visual analog scale and pill counting.	1 year
Secondary	Quality of life	Individual patient would be measured by PozQoL. PozQoL is a tool measuring quality of life among people with HIV.	1 year