NCT03751046

Cognitive Therapy in Patients Failing ART

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Fundação Bahiana de Infectologia · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HIV
• Cognitive Therapy

Interventions

Type	Name	Description
BEHAVIORAL	Trial-Based Cognitive Therapy	Participants in the TBCT intervention arm will have 14 (fourteen) psychotherapy sessions over a period of 7 (seven) months. The frequency of the intervention is biweekly with a duration of approximately 90 minutes per session. We will have10 groups with 5 participants each. All participants will practice the learned techniques during the meetings, have a manual with a description summary of the sessions and the activities to practice at home. The main TBCT techniques that will be used are case conceptualization, intrapersonal thought record, consensual role-play, action plan, trial-based thought record and trial-based metacognitive awareness.
OTHER	Control group. Standard healthcare.	Participants with therapeutic failure, receiving the standard healthcare in the HIV / AIDS Program, which includes at least a half-yearly psychology and pharmaceutical chemist consultations (approximately half an hour each). The purpose of these consultations is to approach the importance of adherence and psychoeducation on HIV

Timeline

• Start date: 2019-03-17
• Primary completion: 2020-03-18
• Completion: 2020-03-18
• First posted: 2018-11-23
• Last updated: 2021-02-04

Locations

1 site across 1 country: Colombia