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

NCT03878186 | Unknown

• 1 other identifier: REF. 2695
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• Threat appraisal: Difference in the average scores of threat appraisal at week 8 (continuous)

  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.

  Measured at baseline and week 8

• Threat appraisal: Proportion of subjects with success (change >54% in threat appraisal at week 8 (nominal binary)

  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.

  Measured at baseline and week 8

Secondary Outcomes (11)

• Challenge appraisal: Difference in the average scores of challenge appraisal

  Measured at baseline and weeks 8, 20 and 52

• Positive and negative affect: Difference in the average scores of positive and negative affect

  Measured at baseline and weeks 8, 20 and 52

• Adherence to HIV therapy: Proportion of subjects with adherence >85%

  Measured at baseline and weeks 8, 20 and 52

• Health related quality of life: Difference in the average scores of quality of life

  Measured at baseline and weeks 8, 20 and 52

• Depression and anxiety: Difference in the average scores of depression and anxiety

  Measured at baseline and weeks 8, 20 and 52

Other Outcomes (4)

• Adherence

  Measured at week 52

• Viral supression

  Measured at month 10

• Retention in care

  Measured at week 52

Study Arms (2)

Cognitive behavioral therapy (CBT)

EXPERIMENTAL

Cognitive behavioral therapy (CBT). Participants will receive the usual care and 6 sessions of cognitive behavioral therapy

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

Usual Care (UC)

OTHER

Participants will receive Usual Care only

Other: Usual Care (UC)

Interventions

Usual Care (UC) OTHER

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

Cognitive behavioral therapy (CBT); Usual Care (UC)

Cognitive Behavioral Therapy (CBT) BEHAVIORAL

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.

Cognitive behavioral therapy (CBT)

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

Mexico City, 14080, Mexico

Location

Related Publications (14)

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  PMID: 22888085 BACKGROUND

• Nogueda-Orozco MJ, Fresán-Orellana A, Vite-Sierra A, Sánchez-Sosa JJ, Robles-García R. Escala de apreciación cognitiva del VIH/SIDA: Adaptación y evaluación psicométrica en población mexicana. Psicología Iberoamericana, 14; 55-60, 2015.

  BACKGROUND

• Pakenham K, Rinaldis M. Development of the HIV/AIDS Stress Scale. Psychology and Health, 17(2):203-219, 2002

  BACKGROUND

• Pakenham KI, Rinaldis M. The role of illness, resources, appraisal, and coping strategies in adjustment to HIV/AIDS: the direct and buffering effects. J Behav Med. 2001 Jun;24(3):259-79. doi: 10.1023/a:1010718823753.

  PMID: 11436546 BACKGROUND

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  BACKGROUND

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  PMID: 12587414 BACKGROUND

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  BACKGROUND

• Molina-Lopez A, Cruz-Islas JB, Palma-Cortes M, Guizar-Sanchez DP, Garfias-Rau CY, Ontiveros-Uribe MP, Fresan-Orellana A. Validity and reliability of a novel Color-Risk Psychiatric Triage in a psychiatric emergency department. BMC Psychiatry. 2016 Feb 10;16:30. doi: 10.1186/s12888-016-0727-7.

  PMID: 26860593 BACKGROUND

• Mejia-Castrejon J, Sierra-Madero JG, Belaunzaran-Zamudio PF, Fresan-Orellana A, Molina-Lopez A, Alvarez-Mota AB, Robles-Garcia R. Development and content validity of EVAD: A novel tool for evaluating and classifying the severity of adverse events for psychotherapeutic clinical trials. Psychother Res. 2024 Apr;34(4):475-489. doi: 10.1080/10503307.2023.2239448. Epub 2023 Aug 8.

  PMID: 37552872 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Depression

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Jessica Mejía Castrejón

  Universidad Nacional Autonoma de Mexico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctoral student. Staff psychologist

Study Record Dates

• First Submitted: February 9, 2019
• First Posted: March 18, 2019
• Study Start: March 26, 2019
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2023
• Last Updated: March 5, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)