Clinical Trials

MainTitle

Efficacy Of A Cognitive Behavioral Therapy To Decrease Threat Appraisal In HIV Participants Initiating Antiretroviral (AppraHIV)

This study is currently recruiting participants. (see Contacts and Locations)

Verified April 2019 by Jessica Mejía Castrejón, Universidad Nacional Autonoma de Mexico

Sponsor
National Institute of Medical Sciences and Nutrition, Salvador Zubiran

Collaborator
Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente

Information provided by (Responsible Party)
Jessica Mejía Castrejón, Universidad Nacional Autonoma de Mexico

ClinicalTrials.gov Identifier
NCT03878186

First received: February 9, 2019
Last updated: April 12, 2019
Last Verified: April 2019
History of Changes
Purpose

Purpose

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.

Condition Intervention
HIV
Threat Appraisal

Other : Usual Care (UC)
Behavioral : Cognitive Behavioral Therapy (CBT)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy Of A Cognitive Behavioral Therapy To Decrease Threat Appraisal In Participants With HIV Infection Initiating Antiretroviral Treatment: Clinical Trial

Further study details as provided by Jessica Mejía Castrejón, Universidad Nacional Autonoma de Mexico:

Primary Outcome Measures

  • Threat appraisal: Difference in the average scores of threat appraisal at week 8 (continuous) [ Time Frame: Measured at baseline and week 8 ]
    Subscale of threat appraisal from HIV/AIDS Stress Scale (EAC-VIH). The subescale of threat appraisal is a validated self-report questionnaire, with 6 items. Participants rate how much they perceived HIV-related problem has damaged different areas (including life goals, self-respect and health) according to likert scale from 1 (no harm) to 5 (extremely harmful). Scores are summed and transformed in percentages. High values indicate worst severity of threat.
  • Threat appraisal: Proportion of subjects with success (change >54% in threat appraisal at week 8 (nominal binary) [ Time Frame: Measured at baseline and week 8 ]
    Subscale of threat appraisal from HIV/AIDS Stress Scale (EAC-VIH). The subescale of threat appraisal is a validated self-report questionnaire, with 6 items. Participants rate how much they perceived HIV-related problem has damaged different areas (including life goals, self-respect and health) according to likert scale from 1 (no harm) to 5 (extremely harmful). Scores are summed and transformed in percentages. High values indicate worst severity of threat.
Secondary Outcome Measures:
  • Challenge appraisal: Difference in the average scores of challenge appraisal [ Time Frame: Measured at baseline and weeks 8, 20 and 52 ]
    Subscale of challenge appraisal from HIV/AIDS Stress Scale (EAC-VIH). The subescale of challenge appraisal is a validated self-report questionnaire with 3 items. Participants indicate the extent to which the HIV-problem related provided potential for personal growth, personal challenge or strengthening for a relationship. Challenge appraisal is rated according to 5 Likert scale from 1 (nil potential) to 5 (high potential). Scores are summed and transformed in percentages. High values indicate high potential for growth.
  • Positive and negative affect: Difference in the average scores of positive and negative affect [ Time Frame: Measured at baseline and weeks 8, 20 and 52 ]
    Positive and negative affect Schedule (PANAS): PANAS is a validated self-report measure of affect. This scale has 20 items distributed in 2 scales (positive affect and negative affect) The subjects are instructed to rate the extent to which they experienced each mood state on a 5-point scale (1= very slightly or not at all - 5 = extremely) during the past week. The total score is the sum of the 10 positive items and the 10 negative items. Scores range from 10 to 50 for both set of items. High scores in positive affect indicate high pleasant states. High scores in negative affect indicate high unpleasant states.
  • Adherence to HIV therapy: Proportion of subjects with adherence >85% [ Time Frame: Measured at baseline and weeks 8, 20 and 52 ]
    Questionnaire to evaluate the adherence to HIV therapy (CEAT-VIH). CEAT-VIH is a self-reported questionnaire that assess the level of adherence to antiretroviral therapy. This multidimensional questionnaire has 20 items. Most items are rated using likert scale. The scores range from 17 to 89. Strict adherence = percentile ≥ 85, insufficient adherence = ≤84.
  • Health related quality of life: Difference in the average scores of quality of life [ Time Frame: Measured at baseline and weeks 8, 20 and 52 ]
    Medical Outcomes Study HIV Health Survey (MOS-HIV). MOS-HIV is a self-administered measure of functional status and well-being in HIV patients. It includes 35 items and assesses 10 dimensions. The scores are transformed to a standardized scale ranging from 0% to 100%, where higher scores indicate better quality of life.
  • Depression and anxiety: Difference in the average scores of depression and anxiety [ Time Frame: Measured at baseline and weeks 8, 20 and 52 ]
    Hospital Anxiety and Depression Scale (HAD). HADS is a fourteen ítem scale with 2 scales. Seven of the items evaluate anxiety, and seven evaluate depression. Each scale rage from 0 to 21. Higher scores indicate higher anxiety/depression complains.
  • Social support: Propotion of subjects with high social support and success in CBT [ Time Frame: Measured at baseline and weeks 8, 20 and 52 ]
    Social Support Questionnaire (SSQ-6). The SSQ-6 quantifies the number of social supports, and satisfaction with social support that is available. The satisfaction ratings are on a 6 point scale ranging from 1 (very dissatisfied) to 6 (very satisfied). The score is calculated averaging the satisfaction score ratings. Scores ≥ 5 in satisfaction with social support will be considered as high social support in this investigation.
  • Viral load: Proportion of subjects with viral supression [ Time Frame: Measured at baseline and month 2, 6 and 10 ]
    Changes in RNA viral load. Viral suprression (cv<400copies/ml)
  • Loss to follow-up. Proportion of subjects with loss to follow-up [ Time Frame: Measured at weeks 8, 20 and 52 ]
    Measure of any missing visit (any missing visits = loss to follow-up)
  • Adverse events: Frequency and severity of adverse events [ Time Frame: Intentional evaluation: Every week until week 8 Report of adverse events until week 52 ]
    Intentional detection of adverse events will be done using a checklist designed for this study. Classification of adverse events will be done using a modified version of Color-Risk Psychiatric Triage (CRPT)
  • Demographic data: Proportion of subjects by subgroups (age, viral load, etc.), with success in CBT. [ Time Frame: Measured at week 8, 20 and 52 ]
    Demographic data. Succes: change of 54% in threat appraisal
  • Change in threat appraisal and challenge appraisal in every group (CBT, UC) [ Time Frame: Measured at week 8, 20 and 52 ]
    The subescale of threat appraisal is a validated self-report questionnaire, with 6 items. Participants rate how much they perceived HIV-related problem has damaged different areas (including life goals, self-respect and health) according to likert scale from 1 (no harm) to 5 (extremely harmful). Scores are summed and transformed in percentages. High values indicate worst severity of threat.
Other Outcome Measures:
  • Adherence [ Time Frame: Measured at week 52 ]
    Proportion of participants with adherence ≥95% (Pharmacy pick-up)
  • Viral supression [ Time Frame: Measured at month 10 ]
    Proportion of participants with viral suppression (viral load ≤400/ml)
  • Retention in care [ Time Frame: Measured at week 52 ]
    Proportion of participants retained in care (at least 2 clinic visits per year separated by at least 90 days)
  • Adverse events [ Time Frame: Measured at week 52 ]
    Proportion of participants with adverse events

Estimated Enrollment: 50
Study Start Date: March 26, 2019
Estimated Study Completion Date: August 31, 2021
Estimated Primary Completion Date: August 31, 2020 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: Cognitive behavioral therapy (CBT)
Cognitive behavioral therapy (CBT). Participants will receive the usual care and 6 sessions of cognitive behavioral therapy
Other: Usual Care (UC)

Usual Care: single in-person psycho-educative session with information about HIV, transmission, natural history of the disease, importance of antiretroviral adherence. All the information is based on guidelines and information sheets from InfoVIHt

Behavioral: Cognitive Behavioral Therapy (CBT)

Cognitive behavioral therapy (CBT): Usual Care + Cognitive-behavioral therapy program intervention (AppraHIV). This intervention involves 7 in-person weekly sessions based on Adjuvant Psychological Therapy centered in three areas: cognitive appraisal, affect and adherence and self-care, everyone with different techniques: cognitive techniques, diaphragmatic breathing, scheduling pleasurable activities, use of pillbox, solving problems, planning for the future, etc. The intervention was manualized (according to Template for Intervention Description and Replication TIDieR), piloted and validated.

Other: Usual Care (UC)
Participants will receive Usual Care only
Other: Usual Care (UC)

Usual Care: single in-person psycho-educative session with information about HIV, transmission, natural history of the disease, importance of antiretroviral adherence. All the information is based on guidelines and information sheets from InfoVIHt

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03878186

Contacts

Contact:   Jessica Mejía Castrejón 54870900 ext 5506 jessica.mejia@infecto.mx
Contact:   Pablo F Belaunzarán Zamudio 54870900 ext 5502 p.belaunz@infecto.mx

Locations

Mexico
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán Recruiting
Mexico City, Mexico, 14080
Contact: Jessica Mejía Castrejón, PHD student    54870900 ext 5506    jessica.mejia@infecto.mx

Sponsors and Collaborators

National Institute of Medical Sciences and Nutrition, Salvador Zubiran
Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente

Investigators

Principal Investigator: Jessica Mejía Castrejón Universidad Nacional Autonoma de Mexico
More Information

More Information


Responsible Party: Jessica Mejía Castrejón, Doctoral student. Staff psychologist, Universidad Nacional Autonoma de Mexico  
ClinicalTrials.gov Identifier: NCT03878186   History of Changes  
Other Study ID Numbers: REF. 2695  
Study First Received: February 9, 2019  
Last Updated: April 12, 2019  
Individual Participant Data    
Plan to Share IPD: No  

Studies a U.S. FDA-regulated Drug Product: No  
Studies a U.S. FDA-regulated Device Product: No  

Keywords provided by Jessica Mejía Castrejón, Universidad Nacional Autonoma de Mexico:

HIV
Threat appraisal
Cognitive behavioral therapy
Antiretroviral-naïve
Challenge appraisal
Affect
Adherence
Quality of life
Anxiety
Depression
Viral load
Loss to follow-up

ClinicalTrials.gov processed this data on June 02, 2020
This information is provided by ClinicalTrials.gov.