HIVAppraHIVNCT03878186
Efficacy Of A Cognitive Behavioral Therapy To Decrease Threat Appraisal In HIV Participants Initiating Antiretroviral
A study testing Cognitive Behavioral Therapy (CBT) in people with HIV and Threat Appraisal, run by National Institute of Medical Sciences and Nutrition, Salvador Zubiran at 1 site in Mexico.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, Threat Appraisal
- What is being tested?
- Cognitive Behavioral Therapy (CBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteMexico
- Study dates
- 26 Mar 2019to 31 Aug 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Psychotic symptoms
- Severe depression
- Severe anxiety
- Suicide risk
- Substance dependence
- Cognitive dysfunction
- Psychological or psychiatric treatment within previous 3 months
- Require emergency medical attention
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
Mexico City, 14080
About this study
Official title: Efficacy Of A Cognitive Behavioral Therapy To Decrease Threat Appraisal In Participants With HIV Infection Initiating Antiretroviral Treatment: Clinical Trial
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.
Read more
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
- Being tested
- Usual Care (UC), Cognitive Behavioral Therapy (CBT)
- Keywords
- HIV, Threat appraisal, Cognitive behavioral therapy, Antiretroviral-naïve, Challenge appraisal, Affect, Adherence, Quality of life, Anxiety, Depression, Viral load, Loss to follow-up
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive behavioral therapy (CBT) | Experimental | Cognitive behavioral therapy (CBT). Participants will receive the usual care and 6 sessions of cognitive behavioral therapy Receives: Other: Usual Care (UC); Behavioral: Cognitive Behavioral Therapy (CBT) |
| Usual Care (UC) | Other | Participants will receive Usual Care only Receives: Other: Usual Care (UC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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: Measured at baseline and week 8
Secondary outcomes (11)
Challenge appraisal: Difference in the average scores of challenge appraisal
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.
Measured: Measured at baseline and weeks 8, 20 and 52
Positive and negative affect: Difference in the average scores of positive and negative affect
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.
Measured: Measured at baseline and weeks 8, 20 and 52
Adherence to HIV therapy: Proportion of subjects with adherence >85%
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.
Measured: Measured at baseline and weeks 8, 20 and 52
Health related quality of life: Difference in the average scores of quality of life
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.
Measured: Measured at baseline and weeks 8, 20 and 52
Depression and anxiety: Difference in the average scores of depression and anxiety
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.
Measured: Measured at baseline and weeks 8, 20 and 52
Social support: Propotion of subjects with high social support and success in CBT
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.
Measured: Measured at baseline and weeks 8, 20 and 52
Viral load: Proportion of subjects with viral supression
Changes in RNA viral load. Viral suprression (cv<400copies/ml)
Measured: Measured at baseline and month 2, 6 and 10
Loss to follow-up. Proportion of subjects with loss to follow-up
Measure of any missing visit (any missing visits = loss to follow-up)
Measured: Measured at weeks 8, 20 and 52
Adverse events: Frequency and severity of adverse events
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)
Measured: Intentional evaluation: Every week until week 8 Report of adverse events until week 52
Demographic data: Proportion of subjects by subgroups (age, viral load, etc.), with success in CBT.
Demographic data. Succes: change of 54% in threat appraisal
Measured: Measured at week 8, 20 and 52
Change in threat appraisal and challenge appraisal in every group (CBT, UC)
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: Measured at week 8, 20 and 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2019
- Study start26 Mar 2019
- Primary completion31 Aug 2022 (estimated)
- Study completion31 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Medical Sciences and Nutrition, Salvador Zubiran
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente
- Responsible party
- Principal investigator, Jessica Mejía Castrejón, Universidad Nacional Autonoma de Mexico
- Investigators
- Jessica Mejía Castrejón, Principal investigator, Universidad Nacional Autonoma de Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03878186
- Sponsor's protocol ID
- REF. 2695
- Acronym
- AppraHIV
- Status last verified
- Mar 2021
- First submitted
- 9 Feb 2019
- Last updated
- 5 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No. There is not a plan to make individual participant data IPD available
Publications
Ahrari S, Mohammadpour A, Amouzeshi Z, Agha-Yousefi A. The Relationship between Cognitive Appraisal and Adherence to Medical Regimens in Type 2 Diabetic Patients. J Caring Sci. 2014 Dec 1;3(4):277-85. doi: 10.5681/jcs.2014.030. eCollection 2014 Dec.
PubMed 25717457Kennedy P, Lude P, Elfstrom ML, Smithson E. Cognitive appraisals, coping and quality of life outcomes: a multi-centre study of spinal cord injury rehabilitation. Spinal Cord. 2010 Oct;48(10):762-9. doi: 10.1038/sc.2010.20. Epub 2010 Mar 9.
PubMed 20212500Bigatti SM, Steiner JL, Miller KD. Cognitive appraisals, coping and depressive symptoms in breast cancer patients. Stress Health. 2012 Dec;28(5):355-61. doi: 10.1002/smi.2444. Epub 2012 Aug 10.
PubMed 22888085Nogueda-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.
Pakenham K, Rinaldis M. Development of the HIV/AIDS Stress Scale. Psychology and Health, 17(2):203-219, 2002
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.
PubMed 11436546Meade CS, Wang J, Lin X, Wu H, Poppen PJ. Stress and coping in HIV-positive former plasma/blood donors in China: a test of cognitive appraisal theory. AIDS Behav. 2010 Apr;14(2):328-38. doi: 10.1007/s10461-008-9494-x. Epub 2009 Jan 6.
PubMed 19127424Robles R, Páez F. Estudio sobre la traducción al español y las propiedades psicométricas de las escalas de afecto positivo y negativo (PANAS). Salud mental, 26(1): 69-75, 2003.
Remor E. Valoración de la adhesión al tratamiento antirretroviral en pacientes VIH positivo. Psicothema,14 (2): 262-267, 2002.
Pena de Leon E, Aguilar Gaytan SS, Suarez Mendoza AA, Reyes Teran G. [A validation of the MOS-HIV quality of life measure in HIV-infected patients in Mexico]. Rev Panam Salud Publica. 2007 May;21(5):313-9. doi: 10.1590/s1020-49892007000400007. Spanish.
PubMed 17697485Lopez-Alvarenga JC, Vazquez-Velazquez V, Arcila-Martinez D, Sierra-Ovando AE, Gonzalez-Barranco J, Salin-Pascual RJ. [Accuracy and diagnostic utility of the Hospital Anxiety and Depression Scale (HAD) in a sample of obese Mexican patients]. Rev Invest Clin. 2002 Sep-Oct;54(5):403-9. Spanish.
PubMed 12587414Robles R, Morales M, Jimenez LM, Morales J. Depresión y ansiedad en mujeres con cáncer de mama: el papel de la afectividad y el soporte social. Psicooncología, 6:191-201, 2009.
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.
PubMed 26860593Mejia-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.
PubMed 37552872
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Of A Cognitive Behavioral Therapy To Decrease Threat Appraisal In Participants With HIV Infection Initiating Antiretroviral Treatment: Clinical Trial
- ClinicalTrials.gov ID
- NCT03878186
- Acronym / sponsor ID
- AppraHIV / REF. 2695
- Conditions
- HIV, Threat Appraisal
- Keywords
- HIV, Threat appraisal, Cognitive behavioral therapy, Antiretroviral-naïve, Challenge appraisal, Affect, Adherence, Quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National Institute of Medical Sciences and Nutrition, Salvador ZubiranUniversity, hospital or other
- Collaborators
- Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente
- Study start
- 26 Mar 2019 (actual)
- Primary completion
- 31 Aug 2022 (estimated)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 18 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive behavioral therapy (CBT) | Experimental | Other: Usual Care (UC), Behavioral: Cognitive Behavioral Therapy (CBT)Cognitive behavioral therapy (CBT). Participants will receive the usual care and 6 sessions of cognitive behavioral therapy |
| Usual Care (UC) | Other | Other: Usual Care (UC)Participants will receive Usual Care only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- Psychotic symptoms
- Severe depression
- Severe anxiety
- Suicide risk
- Substance dependence
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | Cognitive behavioral therapy (CBT), Usual Care (UC) |
| 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. | Behavioural | Cognitive behavioral therapy (CBT) |
Primary outcome
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.
11 secondary outcomes
Challenge appraisal: Difference in the average scores of challenge appraisal
Time frame: Measured at baseline and weeks 8, 20 and 52
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
Adherence to HIV therapy: Proportion of subjects with adherence >85%
Time frame: Measured at baseline and weeks 8, 20 and 52
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
Depression and anxiety: Difference in the average scores of depression and anxiety
Time frame: Measured at baseline and weeks 8, 20 and 52
Social support: Propotion of subjects with high social support and success in CBT
Time frame: Measured at baseline and weeks 8, 20 and 52
Viral load: Proportion of subjects with viral supression
Time frame: Measured at baseline and month 2, 6 and 10
Loss to follow-up. Proportion of subjects with loss to follow-up
Time frame: Measured at weeks 8, 20 and 52
Adverse events: Frequency and severity of adverse events
Time frame: Intentional evaluation: Every week until week 8 Report of adverse events until week 52
Demographic data: Proportion of subjects by subgroups (age, viral load, etc.), with success in CBT.
Time frame: Measured at week 8, 20 and 52
Change in threat appraisal and challenge appraisal in every group (CBT, UC)
Time frame: Measured at week 8, 20 and 52
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2021.
- Background: PubMed 25717457Ahrari S, Mohammadpour A, Amouzeshi Z, Agha-Yousefi A. The Relationship between Cognitive Appraisal and Adherence to Medical Regimens in Type 2 Diabetic Patients. J Caring Sci. 2014 Dec 1;3(4):277-85. doi: 10.5681/jcs.2014.030. eCollection 2014 Dec.
- Background: PubMed 20212500Kennedy P, Lude P, Elfstrom ML, Smithson E. Cognitive appraisals, coping and quality of life outcomes: a multi-centre study of spinal cord injury rehabilitation. Spinal Cord. 2010 Oct;48(10):762-9. doi: 10.1038/sc.2010.20. Epub 2010 Mar 9.
- Background: PubMed 22888085Bigatti SM, Steiner JL, Miller KD. Cognitive appraisals, coping and depressive symptoms in breast cancer patients. Stress Health. 2012 Dec;28(5):355-61. doi: 10.1002/smi.2444. Epub 2012 Aug 10.
- BackgroundNogueda-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.
- BackgroundPakenham K, Rinaldis M. Development of the HIV/AIDS Stress Scale. Psychology and Health, 17(2):203-219, 2002
- Background: PubMed 11436546Pakenham 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.
- Background: PubMed 19127424Meade CS, Wang J, Lin X, Wu H, Poppen PJ. Stress and coping in HIV-positive former plasma/blood donors in China: a test of cognitive appraisal theory. AIDS Behav. 2010 Apr;14(2):328-38. doi: 10.1007/s10461-008-9494-x. Epub 2009 Jan 6.
- BackgroundRobles R, Páez F. Estudio sobre la traducción al español y las propiedades psicométricas de las escalas de afecto positivo y negativo (PANAS). Salud mental, 26(1): 69-75, 2003.
- BackgroundRemor E. Valoración de la adhesión al tratamiento antirretroviral en pacientes VIH positivo. Psicothema,14 (2): 262-267, 2002.
- Background: PubMed 17697485Pena de Leon E, Aguilar Gaytan SS, Suarez Mendoza AA, Reyes Teran G. [A validation of the MOS-HIV quality of life measure in HIV-infected patients in Mexico]. Rev Panam Salud Publica. 2007 May;21(5):313-9. doi: 10.1590/s1020-49892007000400007. Spanish.
- Background: PubMed 12587414Lopez-Alvarenga JC, Vazquez-Velazquez V, Arcila-Martinez D, Sierra-Ovando AE, Gonzalez-Barranco J, Salin-Pascual RJ. [Accuracy and diagnostic utility of the Hospital Anxiety and Depression Scale (HAD) in a sample of obese Mexican patients]. Rev Invest Clin. 2002 Sep-Oct;54(5):403-9. Spanish.
- BackgroundRobles R, Morales M, Jimenez LM, Morales J. Depresión y ansiedad en mujeres con cáncer de mama: el papel de la afectividad y el soporte social. Psicooncología, 6:191-201, 2009.
- Individual participant dataSharing planned: No. No. There is not a plan to make individual participant data IPD available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica Mejía Castrejón principal investigator
Universidad Nacional Autonoma de Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy (CBT) in people with HIV and Threat Appraisal, run by National Institute of Medical Sciences and Nutrition, Salvador Zubiran at 1 site in Mexico.
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 7 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 5 Mar 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 Mexico. 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?
Results are not available in the source record.
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?
Threat appraisal: Difference in the average scores of threat appraisal at week 8 (continuous) (time frame: Measured at baseline and week 8). The study lists 2 primary outcomes in all. 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 NCT03878186, which also lists 14 linked publications.
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 5 Mar 2021.