Cognitive Therapy in Patients Failing ART

NCT03751046 | Completed

• 2 other identifiers: EC003U1111-1219-0997
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

HIV; Cognitive therapy; Treatment; HAART; Treatment adherence and compliance

Outcome Measures

Primary Outcomes (1)

• Change in adherence levels to antiretroviral treatment

  The primary efficacy measure is the improvement in adherence to antiretroviral therapy, measured by self-registration of adherence follow-up questionnaire (QOL 702) ACTG (the Clinical Trials Group). This questionnaire assesses the percentage of self-reported adherence in the last 4 days and the reasons for not taking medicines. Individuals who take 95% or more of the prescribed doses are considered adherent. The analyses will be carried out comparing baseline measures with those observed as at seven, ten and thirteen months after the baseline measures in each group; also, comparisons between the intervention group and the control group will be carried out.

  Baseline, seven, ten and thirteen months after the baseline

Secondary Outcomes (5)

• Change in HIV-1 Viral Load

  Baseline, seven, ten and thirteen months after the baseline

• Change in depression levels

  Baseline, seven, ten and thirteen months after the baseline

• Changing anxiety levels

  Baseline, seven, ten and thirteen months after the baseline

• Change in health-related quality of life measured by The Short Form Health Survey questionnaire , SF36

  Baseline, seven, ten and thirteen months after the baseline

• Change in health-related quality of life measured by WHOQOL-VIH BREF

  Baseline, seven, ten and thirteen months after the baseline

Study Arms (2)

Intervention group. Trial-Based Cognitive Therapy

EXPERIMENTAL

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.

Behavioral: Trial-Based Cognitive Therapy

Control group. Standard healthcare.

EXPERIMENTAL

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.

Other: Control group. Standard healthcare.

Interventions

Trial-Based Cognitive Therapy 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.

Also known as: TBCT

Intervention group. Trial-Based Cognitive Therapy

Control group. Standard healthcare. 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

Also known as: Standard healthcare

Control group. Standard healthcare.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Fundação Bahiana de Infectologia: lead

Study Sites (1)

Liga Colombiana de Lucha Contra El Sida

Bogotá, Cundinamarca, 111311498, Colombia

Location

MeSH Terms

Conditions

Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Officials

• Mónica B Narváez, Psychologist, Master

  Federal University of Bahia

  PRINCIPAL INVESTIGATOR

• Carlos R Brites, Post-Doctoral

  Federal University of Bahia

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: November 9, 2018
• First Posted: November 23, 2018
• Study Start: March 17, 2019
• Primary Completion: March 18, 2020
• Study Completion: March 18, 2020
• Last Updated: February 4, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)