Clinical trial NCT03878186: Efficacy Of A Cognitive Behavioral Therapy To Decrease Threat Appraisal In HIV Participants Initiating Antiretroviral
Official title: Efficacy Of A Cognitive Behavioral Therapy To Decrease Threat Appraisal In Participants With HIV Infection Initiating Antiretroviral Treatment: Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: HIV
Threat Appraisal
Keywords: HIV
Threat appraisal
Cognitive behavioral therapy
Antiretroviral-naïve
Challenge appraisal
Affect
Adherence
Quality of life
Anxiety
Depression
Viral load
Loss to follow-up
Lead sponsor: National Institute of Medical Sciences and Nutrition, Salvador Zubiran
Sponsor class: OTHER
Collaborators: name: Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente
First posted: 2019-03-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Studies in the field of health and HIV indicate that threat appraisal is associated with poor adherence to treatment, anxiety, poor quality of life, avoidance behavior, less antiretroviral adherence, negative affect, social, instrumental and emotional stress, depression, global distrés, poor subjective health and psychological distres. Most psychological interventions have been oriented to behavioral aspects, leaving aside cognitive aspects such as threat appraisal, so is necessary to investigate psychological treatments and its impact in threat appraisal an in an clinical and psychological outcomes.

Primary objective: To evaluate the efficacy of a cognitive behavioral therapy (CBT) to decrease threat appraisal in comparison with Usual Care (UC) in HIV patients initiating antiretroviral treatment at week 8.

Secondary objectives: To evaluate the effect of a cognitive behavioral therapy intervention compared with Usual Care in HIV patients initiating antiretroviral treatment in the following variables: challenge appraisal, affect (positive and negative), adherence, quality of life, anxiety and depression, HIV viral load and loss to follow-up at weeks 8, 20 and 52.

Exploratory objectives: To assess the threat appraisal cut-off value that predicts favorable outcomes in adherence, virologic suppression, retention in care and adverse events at week 52.

The study is an open label, single center, parallel group clinical trial, in which 50 participants will be randomly assigned using a blocked design to one of the 2 arms: Usual Care (single individual psycho-educative session) or Cognitive Behavioral Therapy (Usual care + 6 sessions of individual Cognitive Behavioral Therapy). The sample will be conformed with 50 adults with HIV, naïve to ARV treatment, starting care at INCMNSZ, who have scores of threat appraisal ≥40 in the CEAT scale, without severe mental disorders or cognitive impairment. We will use independent t test and chi square and intention to treat analysis for the primary outcome, also for secondary outcomes t student for continuous variables, chi square for categorical variables and per protocol analysis in participants adherent to the intervention.


Eligibility criteria: Inclusion Criteria:

* At least 18 years of age
* HIV diagnosis confirmed
* Naïve to antiretroviral treatment
* Threat appraisal greater than or equal to 40%
* Enrolled at INCMNSZ for medical care
* Be able to read and write
* Willing and able to provide written informed consent

Exclusion Criteria:

* Psychotic symptoms
* Severe depression
* Severe anxiety
* Suicide risk
* Substance dependence
* Cognitive dysfunction
* Psychological or psychiatric treatment within previous 3 months
* Require emergency medical attention

Primary outcomes:
measure: Threat appraisal: Difference in the average scores of threat appraisal at week 8 (continuous)
timeFrame: Measured at baseline and week 8
measure: Threat appraisal: Proportion of subjects with success (change >54% in threat appraisal at week 8 (nominal binary)
timeFrame: Measured at baseline and week 8
Secondary outcomes:
measure: Challenge appraisal: Difference in the average scores of challenge appraisal
timeFrame: Measured at baseline and weeks 8, 20 and 52
measure: Positive and negative affect: Difference in the average scores of positive and negative affect
timeFrame: Measured at baseline and weeks 8, 20 and 52
measure: Adherence to HIV therapy: Proportion of subjects with adherence >85%
timeFrame: Measured at baseline and weeks 8, 20 and 52
measure: Health related quality of life: Difference in the average scores of quality of life
timeFrame: Measured at baseline and weeks 8, 20 and 52
measure: Depression and anxiety: Difference in the average scores of depression and anxiety
timeFrame: Measured at baseline and weeks 8, 20 and 52
measure: Social support: Propotion of subjects with high social support and success in CBT
timeFrame: Measured at baseline and weeks 8, 20 and 52
measure: Viral load: Proportion of subjects with viral supression
timeFrame: Measured at baseline and month 2, 6 and 10
measure: Loss to follow-up. Proportion of subjects with loss to follow-up
timeFrame: Measured at weeks 8, 20 and 52
measure: Adverse events: Frequency and severity of adverse events
timeFrame: Intentional evaluation: Every week until week 8 Report of adverse events until week 52
measure: Demographic data: Proportion of subjects by subgroups (age, viral load, etc.), with success in CBT.
timeFrame: Measured at week 8, 20 and 52
measure: Change in threat appraisal and challenge appraisal in every group (CBT, UC)
timeFrame: Measured at week 8, 20 and 52
Other outcomes:
measure: Adherence
timeFrame: Measured at week 52
measure: Viral supression
timeFrame: Measured at month 10
measure: Retention in care
timeFrame: Measured at week 52
measure: Adverse events
timeFrame: Measured at week 52
Locations:
city: Mexico City
country: Mexico
facility: Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
Study officials:
affiliation: Universidad Nacional Autonoma de Mexico
name: Jessica Mejía Castrejón
role: PRINCIPAL_INVESTIGATOR
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