Clinical trial NCT03823261: 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
Overall status: UNKNOWN
Phase: NA
Conditions: HIV Infections
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2019-01-30
Enrollment: 10
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, open-label cohort study without a control, and no blindness.
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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

Primary outcomes:
measure: Level of depression
timeFrame: 1 year
measure: Level of adherence
timeFrame: 1 year
Secondary outcomes:
measure: Quality of life
timeFrame: 1 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Division of Infectious Diseases, Department of Internal Medicine, Severance Hospital, Yonsei University Health System
Study officials:
References: