Cognitive Therapy in Patients Failing ART (CognitiveTher)

Fundação Bahiana de Infectologia

Status: Completed

Conditions: Cognitive Therapy; HIV

Treatments: Other: Control group. Standard healthcare.; Behavioral: Trial-Based Cognitive Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03751046

U1111-1219-0997 (Other Identifier)

EC003

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Intervention group. Trial-Based Cognitive Therapy

Experimental group

Description:

Participants with therapeutic failure. Fourteen sessions of psychotherapy in group format, using Trial-Based Cognitive Therapy. Frequency: Bi-weekly meetings for seven months. Intervention arm comprises 10 psychotherapy groups with five participants in each group.

Treatment:

Behavioral: Trial-Based Cognitive Therapy

Control group. Standard healthcare.

Experimental group

Description:

Participants with therapeutic failure, receiving standard healthcare in the HIV/AIDS Program, which includes at least 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.

Treatment:

Other: Control group. Standard healthcare.