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HIVCognitiveTherNCT03751046

Cognitive Therapy in Patients Failing ART

A study testing Trial-Based Cognitive Therapy in people with HIV and Cognitive Therapy, run by Fundação Bahiana de Infectologia at 1 site in Colombia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
HIV, Cognitive Therapy
What is being tested?
Trial-Based Cognitive Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteColombia
Study dates
17 Mar 2019to 18 Mar 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Colombia1 site

  • Liga Colombiana de Lucha Contra El Sida

    Bogotá, Cundinamarca, 111311498

Other trials in Colombia

About this study

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

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.

Read more

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.

Being tested
Trial-Based Cognitive Therapy, Control group. Standard healthcare.
Keywords
HIV, Cognitive therapy, Treatment, HAART, Treatment adherence and compliance
Medical subject headings
Treatment Adherence and Compliance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Trial-Based Cognitive TherapyBehavioural

    Also called TBCT

    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.Other

    Also called 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

Study groups in NCT03751046
Study groupRoleWhat they receive
Intervention group. Trial-Based Cognitive TherapyExperimentalParticipants 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.
Receives: Behavioral: Trial-Based Cognitive Therapy
Control group. Standard healthcare.ExperimentalParticipants 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.
Receives: Other: Control group. Standard healthcare.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline, seven, ten and thirteen months after the baseline

Secondary outcomes (5)

  1. Change in HIV-1 Viral Load

    Change in the number of copies in the HIV-1 Viral Load laboratory test result to <50 copies. The analyses will be carried out comparing the results in the baseline times, the results evaluated as at seven, ten and thirteen months after the baseline measures in each group and the comparison between the intervention group and the control group.

    Measured: Baseline, seven, ten and thirteen months after the baseline

  2. Change in depression levels

    Change in depression levels measured by the Beck Depression Inventory (BDI-II), which ranks in four levels according to the following scores: minimum (0-13), moderate (14-19), mild (20-28) and severe (29-63).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 and the comparison between the intervention group and the control group.

    Measured: Baseline, seven, ten and thirteen months after the baseline

  3. Changing anxiety levels

    Change in anxiety levels measured by the Beck Inventory for Anxiety (BAI), which ranks in four levels according to scores: minimum (0-7), moderate (8-15), mild (16-25), and severe (26-63).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 and the comparison between the intervention group and the control group.

    Measured: Baseline, seven, ten and thirteen months after the baseline

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

    The instrument comprises eight multi-item scales: physical functioning, role limitations due to physical problems, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems and mental health. The eight multi-item scales are aggregated into a physical component (PCS) and a mental component summary (MCS) score.

    Physical functioning, role limitations due to physical problems, and bodily pain contribute more significantly to the PCS.

    Social functioning, role limitations due to emotional problems, and mental health contribute more significantly to MCS.

    The normalized scoring of the eight scales using the original 0 to 100 algorithms (raw scores) and the two summary components is performed by OPTUM PRO CoRETM Scoring Software based on norms with a mean of 50 and a standard deviation of 10. Normalized scores allow comparison of the eight domains and quantification of the SF-36 domains that are most affected by specific risk factors.

    Measured: Baseline, seven, ten and thirteen months after the baseline

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

    The instrument has 31 items with some specific items related to HIV/AIDS. Individual items are rated on a 5 point Likert scale where 1 indicates low, negative perceptions and 5 indicates high, positive perceptions. The instrument is scored in six domains: physical health; psychological health; level of independence; social relationship; environmental health and spirituality.

    Domain and facet scores are scaled in a positive direction where higher scores denote higher quality of life. Some facets (Pain and Discomfort, Negative Feelings, Dependence on Medication, Death and Dying) are not scaled in a positive direction, meaning that for these facets higher scores do not denote higher quality of life. These need to be recoded so that high scores reflect better QoL.

    Items are organised by response scale (capacity, frequency, intensity or satisfaction). Instructions for calculation of scores,using the original 0 to 100 algorithms, was obtained from the WHOQOL HIV Coordinator.

    Measured: Baseline, seven, ten and thirteen months after the baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Nov 2018
  2. Study start17 Mar 2019
  3. Primary completion18 Mar 2020
  4. Study completion18 Mar 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03751046
Sponsor's protocol ID
EC003
Other IDs
U1111-1219-0997
Acronym
CognitiveTher
Status last verified
Feb 2021
First submitted
9 Nov 2018
Last updated
4 Feb 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Trial-Based Cognitive Therapy in people with HIV and Cognitive Therapy, run by Fundação Bahiana de Infectologia at 1 site in Colombia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in adherence levels to antiretroviral treatment (time frame: Baseline, seven, ten and thirteen months after the baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03751046.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2021.

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