An interventional study of Transdiagnostic online intervention and TCC online intervention in Emotional Disorder, Stress Related Disorder and Anxiety Disorders, sponsored by Universidad Nacional Autonoma de Mexico. Status unknown at 1 site in Mexico. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-10-18.
Sponsored by Universidad Nacional Autonoma de Mexico · Not applicable, Interventional, and Treatment
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Among 50 studies in Anxiety Disorders with a site in Mexico — 8 open to participants now, 9 under way, none of them phase 3. Anxiety Disorders · Mexico.
Among the 50 studies in Anxiety Disorders with a site in Mexico, this one is the 12th largest by planned enrollment of the 36 interventional ones that give a count, is one of 8 that started in 2021, is one of 28 with no phase, and was the 27th registered.
7,207 studies on the registry are indexed under Anxiety Disorders; 1,682 are open to participants now.
Browse Anxiety Disorders studies →8 of the 50 studies in Anxiety Disorders with a site in Mexico are open now. Recruiting first, the newest first:
Lauro Gutiérrez Castro · Sites in Mexico
Ages 18+ · Men only
Instituto Nacional de Rehabilitacion · Sites in Mexico
Ages 18–65 · Healthy volunteers
Lauro Gutiérrez Castro · Sites in Mexico
Ages 18–60
University of Guadalajara · Sites in Mexico
Ages 18–40 · Women only
Hospital General de Mexico · Sites in Mexico
Ages 18–40
A study can be open while its sites in Mexico have not opened yet or have stopped. Only those recruiting at a site in Mexico →
Of the 944 Anxiety Disorders studies recruiting now, 417 (44%) set no upper age limit and 460 (49%) stop at 75 or younger; 233 take children under 18; 317 take healthy volunteers.
This study: 18 Years to 70 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
50 studies; the count open now beside each. This study's row is marked.
First in 2005; this study’s year is marked. 8 started in 2021.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 159 is above the median of 80 across 6,062 interventional studies indexed under Anxiety Disorders.
Median enrollment 83 across the 36 interventional studies, 753 across the 14 observational. Of the 26 that completed or were terminated, 3 (12%) have results posted.
This tab as a report to print or save as PDF → With an account.
10 of 50 have an industry lead sponsor. The 10 most frequent:
Universidad Nacional Autonoma de Mexico is the lead sponsor of 28 studies on the registry; 9 are open to participants now.
Universidad Nacional Autonoma de Mexico has 2 studies filed under Anxiety Disorders — fewer than ten, so there is no comparison to draw.
3 of the studies in Anxiety Disorders with a site in Mexico that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07590115Lauro Gutiérrez CastroBehavioral Rigidity in Residential Treatment for Substance Use Disorder (RIG-TD) | 2027-04-15 |
| NCT07578142AccexibleAcceXible Speech-Based Screening for Depression and Anxiety in University Students (UAQ, Mexico) | 2027-09 |
| NCT07595614Lauro Gutiérrez CastroNLP Analysis of Weekly Narratives for Dynamic Clinical Assessment in SUD | 2027-09 |
Add all 3 to your calendar (.ics) → With an account.
Among the 50 studies in Anxiety Disorders with a site in Mexico, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The general objective of this study is to determine the indicators of suitability, clinical utility and satisfaction of the transdiagnostic online intervention for the treatment of emotional disorders and those derived from stress and trauma in a Mexican community sample.
The specific aims are:
In recent decades, research findings indicate that cognitive-behavioral interventions, from a disorder-specific perspective, have shown great empirical support and constitute the first-line treatment for anxiety and depression care. However, these treatments are little used. In this regard, various reasons have been noted that explain the limited access and lack of availability to effective interventions; a minority of people actively seek psychological care due to their own condition of emotional distress, for fear of social stigma, for geographical reasons that separate them from health centers, for reasons of time, preference for another type of treatment or self -help, by the high cost of psychological support, which makes it inaccessible and unaffordable for both the user and the public health system. Likewise, it has been exposed that comorbidity between mental disorders, as well as the gap between research findings and clinical practice, could influence the little dissemination of effective treatments; which leads to a lack of up-to-date professionals who provide relevant interventions. Emotional dysregulation of negative affect has been found to be a study factor that is providing relevant data for a better understanding and approach to emotional disorders from a transdiagnostic perspective, a term coined from a dimensional conception to designate effective treatments aimed at two or more specific disorders. Thus, transdiagnostic treatments could help to overcome the drawbacks related to comorbidity between disorders. Now, technological progress has generated alternatives for psychological assistance, both for the evaluation and for the treatment of different emotional disorders. In this regard, the possibilities offered by technologies are highlighted; since the intervention programs supported by the Internet have been empirically tested to achieve effectiveness and efficiency / cost-benefit, and can be key to guaranteeing access to those who the interventions are inaccessible. Thus, the present study has the purpose of knowing the indicators of suitability, clinical utility and satisfaction of the transdiagnostic intervention via videoconferencing for the treatment of emotional disorders and those derived from stress and trauma.
Hypothesis
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Elimination criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Treatment provided in eight individual sessions of 60 min., Once a week by videoconference. The integrity of the treatment will be controlled through the therapist's manual (Barlow et al., 2011) adapted for the Mexican population and to the online modality.
Behavioral: Transdiagnostic online intervention
The TCC intervention program is short, with active, focused and directive participation, in 8 individual weekly sessions of one hour by videoconference.
Behavioral: TCC online intervention
Participants in the control group on the waiting list will be assigned to the intervention after 2 months after randomization and will join the Transdiagnostic intervention.
Based on the theoretical proposal of Barlow et al. (2011) a treatment applicable to all anxiety and mood disorders (unipolar depression) will be implemented. The unified protocol incorporates proven emotion-focused psychological techniques (Ellard et al., 2010). The main components are: (1) motivation for change, understanding emotions, and recognition and observation of emotional response; (2) learn to observe experiences, evaluate and reevaluate thoughts; (3) what is emotional avoidance, emotion and behavior, and awareness and tolerance of physical sensations; (4) emotional exposure to physical sensations and situations and achievements, maintenance and prevention of relapses.
This program incorporates psychological techniques under the cognitive-behavioral model that have demonstrated their effectiveness in online mode (De la Rosa, 2019; Flores et al., 2014). The main components are: (1) psychoeducation, (2) cognitive restructuring, (3) identification and expression of emotions, (4) assertiveness training and (5) problem solving, and (6) relapse prevention. The order of application of each technique is established by the advisor derived from the formulation of treatment of each case to solve the problems raised, under supervision.
Decrease in the score of Beck Anxiety Inventory
Beck Anxiety Inventory ( BAI , Beck \& Steer, 1990). Self-applied instrument that consists of 21 questions that determine the severity with which the symptomatic and behavioral categories of anxiety symptoms present in an individual are presented. High internal consistency and adequate construct validity, divergent and convergent (Robles, Varela, Jurado \& Páez, 2001).
Time frame: 9 weeks
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)
Time frame: 9 weeks
Decrease in the score of Checkable List of Post-Traumatic Stress Disorder for DSM-5 (PCL-5)
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).
Time frame: 9 weeks
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. Version validated into Spanish by De la Rosa et al. (2021). Presents Cronbach's alpha between .84-.74.
Time frame: 9 weeks
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.
Time frame: 9 weeks
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: 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.
Supporting information: Study protocol, Informed consent form
Time frame: This data will be available in december 2022 and it will be available for 5 years. It will be shared in the databases of the journal where the article(s) will be published.
Access criteria: Open access saving personal and sensitive data of the participants.
Start is estimated for Nov 2021; primary completion for Dec 2022, 13 months later.
Of 3,841 non-industry interventional studies with no phase under Anxiety Disorders, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 28. This study's planned 13 months is close to that.
Counting every sponsor, half of 3,943 studies reached it within 12 months; a quarter within 5 and three quarters within 28.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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Universidad Nacional Autonoma de Mexico