Cognitive Therapy in Patients Failing ART

NCT ID: NCT03751046

Last Updated: 2021-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-17
• Study Completion Date: 2020-03-18

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.

Conditions

HIV; Cognitive Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intervention group. Trial-Based Cognitive Therapy

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.

Group Type: EXPERIMENTAL

Trial-Based Cognitive Therapy

Intervention Type: BEHAVIORAL

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.

Control group. Standard healthcare.

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.

Group Type: EXPERIMENTAL

Control group. Standard healthcare.

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: BEHAVIORAL

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

Intervention Type: OTHER

Other Intervention Names

TBCT; Standard healthcare

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundação Bahiana de Infectologia

OTHER

Sponsor Role: lead

Responsible Party

Monica Bibiana Narvaez Betancur

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mónica B Narváez, Psychologist, Master

Role: PRINCIPAL_INVESTIGATOR

Federal University of Bahia

Carlos R Brites, Post-Doctoral

Role: STUDY_CHAIR

Federal University of Bahia

Locations

Liga Colombiana de Lucha Contra El Sida

Bogotá, Cundinamarca, Colombia

Countries

Colombia

Other Identifiers

U1111-1219-0997

Identifier Type: OTHER

Identifier Source: secondary_id

EC003

Identifier Type: -

Identifier Source: org_study_id