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Emotional DisorderNCT05225701

Efficacy of a Transdiagnostic Guided Internet-Delivered Intervention for Emotional, Trauma and Stress-Related Disorders.

A study testing Transdiagnostic guided internet-delivered intervention with synchronous assistance and Transdiagnostic self-guided internet-delivered intervention in people with Emotional Disorder and Trauma and Stressor Related Disorders, run by Universidad Nacional Autonoma de Mexico at 6 sites in Mexico.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

Emotional, trauma and stress-related disorders show high incidence, prevalence, morbidity, and comorbidity rates in Mexico. In recent decades, research findings indicate that cognitive behavioral interventions, from a disorder-specific perspective, are the effective front-line treatment for anxiety and depression… Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
What is being tested?
Transdiagnostic guided internet-delivered intervention with synchronous assistance and Transdiagnostic self-guided internet-delivered intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
153 participants
Where
6 sitesMexico
Study dates
Sep 2022to Dec 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 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • be of legal age; b) voluntarily participate in the study; c) meet diagnostic criteria for emotional disorders (anxiety or depression) in accordance with the International Neuropsychiatric Interview- Mini, version 5.0 (Sheehan et al., 2006), and show a score ≤ 25 in Beck's Anxiety Depression Inventory (Beck \& Steer,1990) and/or ≤ 30 in the Beck-BDI-II Depression Inventory (Beck, Steer \& Brown, 1996); d) have access to computer equipment with an Internet connection; e) have a valid email address; f) have basic digital skills in the use of an operating system and internet browsing.

Who cannot join

  • psychotic disorder; b) alcohol and drug abuse; c) have active suicidal ideation; d) medical condition whose severity or characteristics prevent the intervention; e) be receiving psychological and/or pharmacological treatment during the study.
  • Elimination criteria :
  • not accepting the conditions of informed consent and b) absence on web or mobile platform for more than 15 days or having missed two consecutive sessions of synchronous treatment sessions.

Trial locations and contacts

6 sites in 1 country.

Anabel De la Rosa-Gómez, PhD contact

525537346590

anabel.delarosa@iztacala.unam.mx

Lorena A Flores-Plata, PhD contact

525556231344

lorena.flores@iztacala.unam.mx

6 sites in 1 country

Mexico6 sites
  • Autonomous University of Ciudad Juarez

    Ciudad Juárez, Chihuahua, 32300

    Esteban E Esquivel Santoveña, PhD, esteban.esquivel@uacj.mx

    Rosa O Castellanos Vargas, MA, rosa.castellanos@uacj.mx

  • Instituto Tecnológico de Sonora

    Ciudad Obregón, Sonora, 85000

    Raquel García-Flores, PhD, raquel.garcia@itson.edu.mx

    Teresa I Sotelo Quiñonez, PhD

  • Faculty of Psychology, National Autonomous University of Mexico

    Mexico City, 04510

    Paulina Arenas Landgrave, PhD, palandgr@unam.mx

    Paulina Arenas Landgrave, PhD

  • Comprehensive Mental Health Center, Ministry of Health of Tlaxcala

    Santa Ana Chiautempan, Tlaxcala, 90800

    Rocío Silvestre Ramírez, MA, silvestrerocio@gmail.com

    Edmundo Martell Ruíz, BA

  • Autonomous University of Baja California

    Tijuana, Estado de Baja California, 22260

    Enrique Berra Ruíz, PhD, enrique.berra@uabc.edu.mx

    Agustín J Negrete Cortés, PhD

  • Faculty of Higher Studies Iztacala, National Autonomous University of Mexico

    Tlalnepantla, State of Mexico, Mexico, 54090

    Anabel De la Rosa-Gómez, PhD, anabel.delarosa@iztacala.unam.mx

    Carolina Santillán-Torres Torija, PhD

Other trials in Mexico

About this study

Official title: Acceptability, Efficacy and Moderators of Clinical Change of a Transdiagnostic Guided Internet-Delivered Intervention for Emotional, Trauma and Stress-Related Disorders in the Mexican Population: Randomized Controlled Trial

Emotional, trauma and stress-related disorders show high incidence, prevalence, morbidity, and comorbidity rates in Mexico. In recent decades, research findings indicate that cognitive behavioral interventions, from a disorder-specific perspective, are the effective front-line treatment for anxiety and depression care. However, these treatments are not often used. The reasons for this are: limited access and low availability to effective interventions; a minority of people actively seek psychological care because of their own distress condition, fearing social stigma, because of geographical reasons that separate them from health centers, because of time, preference for other treatment or self-help, for the high cost of treatment, which makes it inaccessible and unaffordable to both, the user, and the public health system. It has also been stated that the comorbidity between mental disorders, as well as the gap between research findings and clinical practice could influence the poor dissemination of effective treatments, resulting in a lack of up-to-date professionals providing relevant interventions. This has motivated the practice of some studies aimed at knowing the moderating, mediating variables and psychological mechanisms that improve the process of clinical change. Emotional deregulation of negative affection has been found to be a moderating factor and/or mediation in addressing emotional disorders from a transdiagnostic perspective, aimed at two or more specific disorders. In this way, transdiagnostic treatments could help overcome the drawbacks related to comorbidity between disorders. However, technological advancement has created alternatives for psychological assistance, highlighting the possibilities offered by technologies since Internet-supported interventions have been empirically tested for effectiveness, efficiency and this efficiency can be key to ensuring access to those who are inaccessible. Thus, the study aims to identify the indicators of efficacy, acceptability, and moderation of clinical change of a transdiagnostic intervention through a telepsychology platform for the treatment of emotional disorders and derived from stress and trauma.

Read the detailed description

Individuals suffering from depression are more likely to develop comorbidity with other mental disorders, an estimated 53% have concurrent symptomatology with some anxiety disorder (Weisel et al., 2018). Stress and traumatic events are among the most relevant causes, between 60% and 80%, contributing to the etiology of emotional disorders. Depression and anxiety have also been deemed to create a condition of greater disability by increasing the severity and chronicity rate of psychological discomfort and is associated with increased mortality in medical conditions such as heart disease, chronic-degenerative or psychiatric conditions (Berenzon et al., 2013). In Mexico, one in four people between the age of 18 and 65 has suffered an emotional disorder at some point in their lives, but only one in five of those with it receive treatment and the time to receive care in a health center ranges from 4 to 20 years depending on the reason for consultation (Berenzon et al., 2013).

In recent decades, cognitive behavioral interventions, from a disorder-specific perspective, constitute an effective and first-line treatment for anxiety and depression care (Cuijpers et al. 2014; Kazdin, 2016); They highlight: a) exposure therapy; b) anxiety management techniques; and c) cognitive therapy, however, however they are not often used (Mohr et al., 2010). In this regard, a number of reasons have been noted explaining limited access and low availability to effective interventions. A minority of people actively seek psychological care because of their own condition of emotional discomfort, fearing social stigma, because of geographical reasons that separate them from health centers, because of reasons of time, preference for other treatment or self-help, because of the high cost of psychological support, which makes it inaccessible and unaffordable to both, the user and the public health system (Berenzon et al., 2013). It has also been argued that the comorbidity between mental disorders, as well as the gap between research findings and clinical practice could influence the poor dissemination of effective treatments; resulting in a lack of up-to-date professionals providing relevant interventions (Holmes, Craske \& Graybiel, 2014). In the same line, Kazdin and Blase (2011) mention that, despite advances in research, mental health professionals have been unsuccessful in reducing the incidence and prevalence of emotional disorders. This has motivated studies aimed at knowing the moderating, mediating variables and psychological mechanisms that improve the process of clinical change (Ebert et al., 2018). In addition, the need has been raised to implement innovative solutions that contribute to the dissemination of effective treatments for the care of emotional disorders( Kazdín \& Rabbitt, 2016).

Faced with this problem, psychological rehabilitation of people diagnosed with depression and anxiety has been found to be mediated by the primary assessment of the event that can be perceived as threat, challenge, or benefit; estimation of control over adverse or stressful stimulus and the resources available to deal with the situation (Folkman \& Moskowitz, 2007). In particular, emotional deregulation of negative affection is a study factor that is providing relevant data for better understanding and approaching emotional disorders from a transdiagnostic perspective, a term coined from a dimensional conception to designate effective treatments targeting two or more specific disorders (Hernández et al., 2011).

This has crucial implications for the possible diagnosis of emotional disorders, since, from a dimensional perspective, consideration of the causes and coping resources that the person has and not only the count of prescribed grouped symptoms takes on relevance. The degree of intensity and effects on the day-to-day functioning of the person are also taken into account. For treatment purposes, it addresses common or shared risk factors between disorders (e.g. emotional disorders), including underlying mechanisms, psychological (cognitive, behavioral and physiological) processes linked to explanatory variables and maintenance of overlapping symptoms (attentional biases, negative thinking, avoidance, etc.), appealing to a convergent and integrative scientific approach (Sandin, 2014). Thus, transdiagnostic treatments could help overcome the disadvantages related to comorbidity between disorders and thus make way for a new generation of emotion-focused treatments (Hernández et al., 2011). In this regard, Barlow, Allen and Choate (2004) return to the tripartite theory of emotion (Clark \& Watson, 1991) and propose a unified cognitive-behavioral transdiagnosis protocol for the treatment of emotional disorders with an emphasis on emotional regulation.

On the one hand, there is evidence of effective transdiagnostic interventions for the treatment of emotional disorders that help overcome the disadvantages related to comorbidity between disorders; and on the other hand, the benefits shown by interventions provided over the Internet and mobile applications by allowing: (1) accessibility: easy access anytime and from anywhere over the Internet, (2) flexibility: the intervention adapts to the participant's pace and the consultation of resources and materials can be asynchronous, (3) customization: the intervention can be adapted to the specific needs of the user, (4) availability of treatment: it allows to bring psychological care to people who need it regardless of distance, which is an alternative when it is not possible to access face-to-face mental health services. In addition, (5) scalability, as it can increase coverage and improve care as technology advances (Díaz-García, 2017; Weisel et al., 2018). Therefore, transdiagnostic interventions focused on the emotion provided online involve enhancing the scope and impact of psychological treatment programs for anxiety and depression (Titov et al., 2013).

While there is evidence of effectiveness, aimed at knowing the impact of the outcome of treatment, other relevant aspects that has not been sufficiently explored are the risk and/or protection factors that cause moderation and mediation effects with respect to the results obtained in treatments (Graaf et al., 2002) for example, to know the profiles that benefit most from interventions (Brookes et al., 2004; Kessler et al., 2017). Identifying variables that moderate or mediate the impact of treatment is important because it could support understanding the heterogeneity of the results. Evidence of the effectiveness of preventive and/or remedial interventions over the Internet in the context of public health for the reduction of the incidence of depressive and anxious symptomatology is still low; the latest systematic review identified seven uncontrolled clinical studies that evaluated the effect of internet-mediated interventions with positive results (Ebert et al., 2017). However, only one clinical study aimed at preventing general anxiety was found that did not produce significant results (Christensen et al., 2014). While three studies managed to reduce the incidence of depression (Buntrock et al., 2016; Dear et al., 2016). In the study conducted by Dear et al. (2016) reported that self-applied internet-guided intervention decreased depressive symptomatology in a group of adults and managed to reduce the risk of chronic depression by 39% per follow-up year. Recent research on the effectiveness of self-applied interventions via the Internet with and without the support of a trained psychologist has indicated that fully self-applied technology-mediated treatments show fewer rates of improvement compared to those who did have synchronous support with a therapist (Richards \& Richardson, 2012). Other studies that have researched the influence of support or guidance during self-applied internet-based interventions have reported that participants who received weekly support significantly improved in reducing depression compared to a waiting list group, while participants who did not receive support did not show significant improvement (Kleiboer et al., 2015). However, some authors propose that the differences in results obtained between guided and non-guided interventions are small or non-existent (Mira et al., 2017). This aspect is relevant for assessing the efficiency of interventions provided with technology, as they could benefit more people who need it with effective results. In general, the research findings mentioned are promising; however, it is also important to note that most studies have been conducted in developed contries, so it is necessary to know the results in controlled studies in the Mexican context and culture and with larger samples to reach stronger conclusions regarding the effectiveness, efficacy and efficiency of transdiagnostic interventions via the Internet for the care of emotional disorders. In addition, it is necessary to investigate what are the suitable applications of the technology, whether or not there is a significant benefit using this technology compared to other strategies that are currently available, and what factors can contribute to these effects (Quero et al., 2012).

In Mexico, research in this area is incipient, emphasizing the need to go beyond traditional face-to-face interventions and to design new intervention strategies. In this regard, the possibilities offered by technologies are highlighted since Internet-supported interventions have been empirically tested to achieve effectiveness and efficiency/cost-benefit and can be key to ensuring access to those who are inaccessible. Thus, in consistency with the National Health Plan, this study aims to respond to this national problem through the evaluation of the effectiveness and moderators of a transdiagnostic intervention for emotional disorders through a telepsychology system.

Being tested
Transdiagnostic guided internet-delivered intervention with synchronous assistance, Transdiagnostic self-guided internet-delivered intervention
Keywords
Transdiagnostic intervention, Guided Internet-Delivered intervention, Mexican population, Adults, Telepsychology, Internet-based treatment
Medical subject headings
Trauma and Stressor Related Disorders, Anxiety Disorders, Depression

What participants receive

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

  • Transdiagnostic guided internet-delivered intervention with synchronous assistanceBehavioural

    Self-applied treatment web system based on transdiagnostic approach for emotional and stress and trauma-derived disorders. The system will contain seven modules: Module 0. Pre-evaluation; Module 1. Psychoeducation and motivation for change; Module 2. Emotional Coping Skills; Module 3. Acceptance and awareness-raising skills focused on the present moment; Module 4. Cognitive coping skills; Module 5. Behavioral coping skills; Module 6. Achievements, maintenance and prevention of relapses; Module 7. Post-evaluation. Each user will be assigned an advisor who will be health personnel (psychologists, social workers, and gerontologists). The function of the psychological advisor is to motivate, guide and listen to the doubts and comments of each participant by providing a weekly session of one hour in individual online format, in addition to the review of the module in platform in self-suggestive format.

  • Transdiagnostic self-guided internet-delivered interventionBehavioural

    Self-applied treatment web system based on transdiagnostic approach for emotional and stress and trauma-derived disorders. The system will contain seven modules: Module 0. Pre-evaluation; Module 1. Psychoeducation and motivation for change; Module 2. Emotional Coping Skills; Module 3. Acceptance and awareness-raising skills focused on the present moment; Module 4. Cognitive coping skills; Module 5. Behavioral coping skills; Module 6. Achievements, maintenance and prevention of relapses; Module 7. Post-evaluation. Each module will include exercises and tasks for the practice of each technique. Automatic emails with notifications will be sent to access the program when participants have not entered in the last 15 days.

Study groups in NCT05225701
Study groupRoleWhat they receive
Transdiagnostic guided internet-delivered intervention with synchronous assistanceExperimentalSelf-applied treatment web system based on transdiagnostic approach for emotional and stress and trauma-derived disorders. The system will contain seven modules. The duration of the intervention program may vary between users; however, the participant will have access permits for a maximum period of 12 weeks. In order to monitor the participant's progress, each user will be assigned an advisor who will be health personnel (psychologists, social workers, and gerontologists) to get an a weekly personalized synchronous assistance and psychological counseling.
Receives: Behavioral: Transdiagnostic guided internet-delivered intervention with synchronous assistance
Transdiagnostic self-guided internet-delivered interventionActive comparatorSelf-applied treatment web system based on transdiagnostic approach for emotional and stress and trauma-derived disorders. The system will contain seven modules. The duration of the intervention program may vary between users; however, the participant will have access permits for a maximum period of 12 weeks. All modules are sequential, allowing the user to go step by step. This arm does not have personalized online assistance.
Receives: Behavioral: Transdiagnostic self-guided internet-delivered intervention
waiting listNo interventionParticipants on the waiting list will be assigned to the intervention after 2 months after randomization and will join the Transdiagnostic guided internet-delivered intervention with synchronous assistance.

What is being measured

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

  1. Decrease in the score of Beck Anxiety Inventory

    Beck Anxiety Inventory (BAI , Beck \& Steer, 1990). The BAI is a 21-item self-report measure of the severity of common affective, cognitive, and somatic symptoms of anxiety. Items have four response options ranging from 0 "not at all" to 3 "severely". The cut-off points are: 0-5 minimal anxiety, 6-15 mild anxiety, 16-30 moderate anxiety and 31-63 severe anxiety. High internal consistency and adequate construct validity, divergent and convergent for the Mexican version has been documented (Cronbach's alpha = .83) (Robles et al., 2001).

    Measured: 9 weeks

  2. Decrease in the score of Beck Depression Inventory

    Beck Depression Inventory (BDI-II; Beck, Steer \& Brown, 1996). It consists of 21 items that fundamentally evaluate the clinical symptoms of melancholy and the intrusive thoughts present in depression. Cronbach's alpha for version II (= .87-.92). Each statement has four response options that reflect increasing symptom frequency or severity. Total scores can range from 0-63 with the following cut-offs points: 0-13 minimally depressed, 14-19 mildly depressed, 20-28 moderately depressed, and 29-63 severely depressed.

    Measured: 9 weeks

  3. Decrease in the score of Post-Traumatic Stress Disorder Checklist

    This instrument describes the symptoms of post-traumatic stress taking into consideration the diagnostic criteria of activation, alterations, avoidance and reexperimentation. It has 20 items that are scored on a Likert-type scale that goes from 0 (not at all) to 4 (totally). In its adaptation to the Mexican population, the psychometric properties of the scale show adequate internal consistency with an alpha of .97, as well as an appropriate convergent validity (rs = .58 to .88; Durón-Figueroa et al., 2019). Items are scored on a Likert scale ranging from 0 to 4, where higher scores indicate more pronounced PTSD symptoms. A cut-off score of 33 was suggested to have a partial diagnosis of PTSD.

    Measured: 9 weeks

  4. Decrease in the score of Scale of Difficulties in Emotional Regulation

    Scale of Difficulties in Emotional Regulation (DERS; Gratz \& Roemer, 2004). It is a self-applied instrument that measures two dimensions through 15 items, emotional regulation strategies and awareness of emotions. The version validated in Mexican population by De la Rosa et al. (2021), presents a Cronbach's Alpha valued between .84 - .74.

    Measured: 9 weeks

  5. Decrease frequency, severity and avoidance of anxiety

    General Anxiety and the Impairment Severity Scale (OASIS) (Norman et al., 2011). It consists of 5 questions with a scale of 0 to 4, which measures frequency, severity and avoidance of anxiety in different fields: work / academic interference / family, and deterioration of social and daily life. It has good internal consistency (α = 0.80) and test-retest reliability (k = 0.82). The Spanish version confirmed the factorial structure, reliability and validity data obtained by the original authors: internal consistency in both populations, in general and clinical (α = 0.86) and test-fail reliability (k = 0.84) (Mira et al., 2015).

    Measured: 9 weeks

  6. Decrease frequency and severity of depression

    General Depression and the Impairment Gravity Scale (ODSIS)(Bentley et al., 2014). This scale evaluates experiences related to depression. It consists of five items with different answer options ranging from 0 to 4 for each item. It measures the frequency and severity of depression, as well as the level of avoidance to work/academic/home interference, and social life. In the Spanish version, the internal consistency has proven to be excellent, with a Cronbach alpha between 0.91 and 0.94 and a good convergent and discriminatory validity (González-Robles et al., 2015).

    Measured: 9 weeks

Secondary outcomes (1)
  1. Increase the level of acceptance and satisfaction of psychological treatment

    Questionnaire with four questions that report the level of satisfaction with the treatment, if you would recommend the treatment to a friend or relative, is the treatment considered useful for your case and if you think that the treatment was difficult to handle or aversive.

    Measured: 9 weeks

Timeline

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

  1. First posted4 Feb 2022
  2. Study startSep 2022 (estimated)
  3. Primary completionDec 2022 (estimated)
  4. Study completionDec 2023 (estimated)

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
A randomized controlled study will be carried out, in accordance with the guidelines set out in the consort (http://www.consort-statement.org) and CONSORT E-Health (https://www.jmir.org/2011/4/e126/). An experimental design will be used between subjects with three independent groups, with intrasubject measurements in four evaluation moments: pretest, posttest, follow-up at 3, 6 and 12 months (Solomon et al. ,2009). Participants will be randomly assigned to one of three conditions: a) Transdiagnostic guided internet-delivered intervention with synchronous assistance; b) Transdiagnostic self-guided internet-delivered intervention; c) waiting list.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
153 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05225701
Sponsor's protocol ID
UNAM_FESI_CONACYT_1401
Status last verified
Jan 2022
First submitted
25 Jan 2022
Last updated
4 Feb 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The information will be available in a private server or in a open server of the journal(s) that we will publish the articles that will be the result of this study. The informed consent is already shared in the register of clinical trials.

Publications

  • Andersson G. Internet-Delivered Psychological Treatments. Annu Rev Clin Psychol. 2016;12:157-79. doi: 10.1146/annurev-clinpsy-021815-093006. Epub 2015 Dec 11.

    PubMed 26652054
  • Barlow DH, Allen LB, Choate ML. Toward a Unified Treatment for Emotional Disorders - Republished Article. Behav Ther. 2016 Nov;47(6):838-853. doi: 10.1016/j.beth.2016.11.005. Epub 2016 Nov 10.

    PubMed 27993336
  • Health Quality Ontario. Internet-Delivered Cognitive Behavioural Therapy for Major Depression and Anxiety Disorders: A Health Technology Assessment. Ont Health Technol Assess Ser. 2019 Feb 19;19(6):1-199. eCollection 2019.

    PubMed 30873251
  • Dominguez-Rodriguez A, De La Rosa-Gomez A, Hernandez Jimenez MJ, Arenas-Landgrave P, Martinez-Luna SC, Alvarez Silva J, Garcia Hernandez JE, Arzola-Sanchez C, Acosta Guzman V. A Self-Administered Multicomponent Web-Based Mental Health Intervention for the Mexican Population During the COVID-19 Pandemic: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2020 Nov 16;9(11):e23117. doi: 10.2196/23117.

    PubMed 33196449
  • Dominguez-Rodriguez A, Martinez-Luna SC, Hernandez Jimenez MJ, De La Rosa-Gomez A, Arenas-Landgrave P, Esquivel Santovena EE, Arzola-Sanchez C, Alvarez Silva J, Solis Nicolas AM, Colmenero Guadian AM, Ramirez-Martinez FR, Vargas ROC. A Self-Applied Multi-Component Psychological Online Intervention Based on UX, for the Prevention of Complicated Grief Disorder in the Mexican Population During the COVID-19 Outbreak: Protocol of a Randomized Clinical Trial. Front Psychol. 2021 Mar 29;12:644782. doi: 10.3389/fpsyg.2021.644782. eCollection 2021.

    PubMed 33854466
  • Ontario Health (Quality). Internet-Delivered Cognitive Behavioural Therapy for Post-traumatic Stress Disorder or Acute Stress Disorder: A Health Technology Assessment. Ont Health Technol Assess Ser. 2021 Jun 1;21(9):1-120. eCollection 2021.

    PubMed 34527087
  • de la Rosa-Gomez A, Flores-Plata LA, Esquivel-Santovena EE, Santillan Torres Torija C, Garcia-Flores R, Dominguez-Rodriguez A, Arenas-Landgrave P, Castellanos-Vargas RO, Berra-Ruiz E, Silvestre-Ramirez R, Miranda-Diaz GA, Diaz-Sosa DM, Hernandez-Posadas A, Flores-Elvira AI, Valencia PD, Vazquez-Sanchez MF. Efficacy of a transdiagnostic guided internet-delivered intervention for emotional, trauma and stress-related disorders in Mexican population: study protocol for a randomized controlled trial. BMC Psychiatry. 2022 Aug 9;22(1):537. doi: 10.1186/s12888-022-04132-6.

    PubMed 35941557

Questions about this trial

What is this clinical trial studying?

A study testing Transdiagnostic guided internet-delivered intervention with synchronous assistance and Transdiagnostic self-guided internet-delivered intervention in people with Emotional Disorder and Trauma and Stressor Related Disorders, run by Universidad Nacional Autonoma de Mexico at 6 sites 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 1 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: status not confirmed, as of the sponsor's last update on 4 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites 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?

Contact Anabel De la Rosa-Gómez, PhD (525537346590, anabel.delarosa@iztacala.unam.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Decrease in the score of Beck Anxiety Inventory (time frame: 9 weeks). The study lists 6 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 NCT05225701, which also lists 7 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 4 Feb 2022.

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