Clinical trial NCT03751046: Cognitive Therapy in Patients Failing ART
Official title: Controlled Clinical Trial Comparing the Efficacy of Trial-Based Cognitive Therapy and Standard Care for the Treatment of HIV+ Patients With Antiretroviral Therapy Failure, Bogotá, Colombia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Cognitive Therapy
Keywords: HIV
Cognitive therapy
Treatment
HAART
Treatment adherence and compliance
Lead sponsor: Fundação Bahiana de Infectologia
Sponsor class: OTHER
First posted: 2018-11-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Highly active antiretroviral therapy (HAART) has been the greatest achievement to control the HIV/AIDS epidemic in the world. HAART has been shown to reduce virus replication to undetectable levels and to favor the recovery of immune function, avoiding the occurrence of opportunistic diseases. Although existing treatments have been shown to lower AIDS-related morbimortality and to increase patients' quality of life, the success of HAART requires high levels of adherence to the prescribed treatment regimen.

Adherence to HAART has become the major challenge for global public policy managers and healthcare teams involved in the care of HIV/AIDS patients. Mental healthcare professionals should use structured and effective intervention as strategies to facilitate a better approach, increase patients' autonomy and achieve optimal adherence.

Trial-Based Cognitive Therapy (TBCT) is a new, structured, and short-term version of cognitive behavior therapy developed by de Oliveira (2011). TBCT is an active approach that aims to change negative cognitions, especially dysfunctional core beliefs, that negatively influence patient's life in different domains. TBCT helps patients recognize situationally based thoughts, unhelpful beliefs and maladaptive behaviors that exacerbate emotional distress.

This study aims to assess the efficacy of TBCT in helping the patients to identify thoughts, emotions, assumptions and behaviors associated with non-adherence to antiretroviral therapy, and to improve adherence to treatment.


Eligibility criteria: Inclusion Criteria:

* The last two detectable CV \> 500 copies
* At least one year of antiretroviral treatment
* Age between 18 and 65 years
* Literate person.

Exclusion Criteria:

* Difficulty to read and to write
* Being currently in psychotherapy
* Clinical diagnoses of neurocognitive or psychotic disorders

Primary outcomes:
measure: Change in adherence levels to antiretroviral treatment
timeFrame: Baseline, seven, ten and thirteen months after the baseline
Secondary outcomes:
measure: Change in HIV-1 Viral Load
timeFrame: Baseline, seven, ten and thirteen months after the baseline
measure: Change in depression levels
timeFrame: Baseline, seven, ten and thirteen months after the baseline
measure: Changing anxiety levels
timeFrame: Baseline, seven, ten and thirteen months after the baseline
measure: Change in health-related quality of life measured by The Short Form Health Survey questionnaire , SF36
timeFrame: Baseline, seven, ten and thirteen months after the baseline
measure: Change in health-related quality of life measured by WHOQOL-VIH BREF
timeFrame: Baseline, seven, ten and thirteen months after the baseline
Other outcomes:
Locations:
city: Bogotá
country: Colombia
facility: Liga Colombiana de Lucha Contra El Sida
state: Cundinamarca
Study officials:
affiliation: Federal University of Bahia
name: Mónica B Narváez, Psychologist, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of Bahia
name: Carlos R Brites, Post-Doctoral
role: STUDY_CHAIR
References: