Emotional DisorderNCT05081830
Online Transdiagnostic Intervention for Emotional Disorders and Stress-related Disorders
A study testing Transdiagnostic online intervention and TCC online intervention in people with Emotional Disorder and Stress Related Disorder, run by Universidad Nacional Autonoma de Mexico at 1 site in Mexico.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Emotional Disorder, Stress Related Disorder, Anxiety Disorders
- What is being tested?
- Transdiagnostic online intervention and TCC online intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 1 siteMexico
- Study dates
- 1 Nov 2021to 31 Dec 2022
- 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;
- voluntarily participate in the study;
- meet diagnostic criteria for emotional disorders (anxiety or depression) according to the International Neuropsychiatric Interview- Mini, version 5.0, and show a score ≤ 25 on the Beck Anxiety Depression Inventory and / or ≤ 30 on the Inventory Depression of Beck-BDI-II,
- have access to a computer equipment with an Internet connection, (e) have a valid email address, (f) have basic digital skills in the use of a system operating and internet browsing.
Who cannot join
- psychotic disorder;
- alcohol and drug abuse;
- medical illness whose severity or characteristics prevent the performance of the intervention;
- be receiving psychological and / or pharmacological treatment during the study.
- Elimination criteria:
- not accepting the conditions of informed consent
- absence in two consecutive sessions to the synchronous treatment sessions.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
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
Lorena A Flores-Plata, PhD, lorena.flores@iztacala.unam.mx
About this study
Official title: Suitability, Clinical Utility and Acceptability of an Online Transdiagnostic Intervention for Emotional Disorders and Stress-related Disorders in Mexican Sample: A Randomized Clinical Trial
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:
- To Carry out a screening evaluation from the transdiagnostic model by evaluating clinical indicators (depression, anxiety, acute / post-traumatic stress, emotional regulation strategies, intolerance to uncertainty) and that allow determining the frequency, intensity and severity of cases identified by type of emotional problem.
- Measure the fidelity of the use of the intervention manual in each treatment condition.
- Evaluate the degree of satisfaction, acceptance, complexity and modality of the transdiagnostic intervention.
- To know the degree of suitability of the transdiagnostic intervention from the point of view of therapists and supervisors in relation to the problems of the studied sample and the recommendations for its improvement.
- To compare the clinical utility of the transdiagnostic intervention via the internet for the treatment of emotional disorders and those derived from stress and trauma against the efficacy of the CBT intervention and the waiting list group.
Read the detailed description
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
- The transdiagnostic intervention program via the internet will reduce symptoms of anxiety / depression and / or comorbid acute stress compared to a cognitive-behavioral treatment (CBT) group and a waiting list group.
- The transdiagnosis intervention program via internet will show statistical gains in the reduction of symptoms of anxiety / depression and / or acute stress, and a clinically significant improvement greater than the CBT intervention program and the waiting list group.
- There will be a higher acceptance / satisfaction index reported by the participants in the transdiagnostic intervention program via the internet compared to the CBT intervention and with the group without treatment.
- It will be found that emotional regulation functions as moderating variables of clinical change.
- The changes will be maintained for three and six months after the end of the transdiagnosis intervention program.
- Being tested
- Transdiagnostic online intervention, TCC online intervention
- Keywords
- online therapy, e-therapy, mexican population, adults, transdiagnostic intervention
- 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.
Transdiagnostic online interventionBehavioural
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.
TCC online interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| transdiagnostic intervention via the Internet | Experimental | 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. Receives: Behavioral: Transdiagnostic online intervention |
| TCC intervention via the Internet | Active comparator | The TCC intervention program is short, with active, focused and directive participation, in 8 individual weekly sessions of one hour by videoconference. Receives: Behavioral: TCC online intervention |
| waiting list control. | No 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
Measured: 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).
Measured: 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.
Measured: 9 weeks
Secondary outcomes (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.
- First posted18 Oct 2021
- Study start1 Nov 2021 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Emotional DisorderStudies 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
- Model description
- A randomized controlled study will be carried out, following the guidelines set forth in the CONSORT statement (http://www.consort-statement.org) and CONSORT EHealth ( https://www.jmir.org/2011/4/e126/ ). An experimental design between subjects with three independent groups will be used, with within-subject measurements at four evaluation moments: pretest, posttest, follow-up at 3 and 6 months (Solomon Solomon, Cavanaugh \& Draine, 2009). Participants will be randomly assigned to one of three conditions: (a) transdiagnostic intervention via the Internet; (b) Cognitive-Behavior Therapy via the Internet; (c) waiting list control.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 159 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Nacional Autonoma de Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anabel De La Rosa Gomez, Universidad Nacional Autonoma de Mexico
- Investigators
- Alejandrina Hernández-Posadas, PhD student, Study chair, Faculty of Higher Studies Iztacala, National Autonomous University of MexicoPablo D Valencia, PhD student, Study chair, Faculty of Higher Studies Iztacala, National Autonomous University of MexicoCarolina Santillán-Torres Torija, PhD, Study chair, Faculty of Higher Studies Iztacala, National Autonomous University of MexicoPaulina Arenas-Landgrave, PhD, Study chair, Faculty of Psychology, National Autonomous University of MexicoBerenice Serrano-Zarate, PhD, Study chair, Universitat Jaume IAlejandro Domínguez-Rodríguez, PhD, Study chair, Valencian International UniversityMario F Vázquez-Sánchez, Ms student, Study chair, Faculty of Higher Studies Iztacala, National Autonomous University of MexicoAlicia I Flores-Elvira, Ms, Study chair, Faculty of Higher Studies Iztacala, National Autonomous University of Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05081830
- Sponsor's protocol ID
- UNAM_FESI_IT300721
- Status last verified
- Oct 2021
- First submitted
- 4 Oct 2021
- Last updated
- 18 Oct 2021
- 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 26652054Andrews G, Cuijpers P, Craske MG, McEvoy P, Titov N. Computer therapy for the anxiety and depressive disorders is effective, acceptable and practical health care: a meta-analysis. PLoS One. 2010 Oct 13;5(10):e13196. doi: 10.1371/journal.pone.0013196.
PubMed 20967242Barlow 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 27993336Cárdenas, G., Botella, C., Quero, S., De la Rosa, A. & Baños, R. Programa de Telepsicología para el Tratamiento de la Fobia a hablar en público en Población Mexicana. Revista Psicología Iberoamericana. 2014; 22 (1): 45-54.
Cárdenas, G., Flores, L. y De la Rosa, A. Psicoterapia vía Internet: Manual de entrenamiento. Facultad de Psicología de la UNAM. DGAPA. 2012. ISBN-978-606-02-2263-4.
Ellard KK, Fairholme CP, Boisseau CL, Farchione TJ, Barlow DH. Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders: Protocol Development and Initial Outcome Data. Cogn Behav Pract. 2010 Feb;17(1):88-101. doi: 10.1016/j.cbpra.2009.06.002. Epub 2010 Jan 29.
PubMed 33762811
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suitability, Clinical Utility and Acceptability of an Online Transdiagnostic Intervention for Emotional Disorders and Stress-related Disorders in Mexican Sample: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05081830
- Acronym / sponsor ID
- UNAM_FESI_IT300721
- Keywords
- online therapy, e-therapy, mexican population, adults, transdiagnostic intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 159 participants (estimated)
- Lead sponsor
- Universidad Nacional Autonoma de MexicoUniversity, hospital or other
- Study start
- 1 Nov 2021 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 18 Oct 2021 (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.
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:
- To Carry out a screening evaluation from the transdiagnostic model by evaluating clinical indicators (depression, anxiety, acute / post-traumatic stress, emotional regulation strategies, intolerance to uncertainty) and that allow determining the frequency, intensity and severity of cases identified by type of emotional problem.
- Measure the fidelity of the use of the intervention manual in each treatment condition.
- Evaluate the degree of satisfaction, acceptance, complexity and modality of the transdiagnostic intervention.
- To know the degree of suitability of the transdiagnostic intervention from the point of view of therapists and supervisors in relation to the problems of the studied sample and the recommendations for its improvement.
- To compare the clinical utility of the transdiagnostic intervention via the internet for the treatment of emotional disorders and those derived from stress and trauma against the efficacy of the CBT intervention and the waiting list group.
Detailed description
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
- The transdiagnostic intervention program via the internet will reduce symptoms of anxiety / depression and / or comorbid acute stress compared to a cognitive-behavioral treatment (CBT) group and a waiting list group.
- The transdiagnosis intervention program via internet will show statistical gains in the reduction of symptoms of anxiety / depression and / or acute stress, and a clinically significant improvement greater than the CBT intervention program and the waiting list group.
- There will be a higher acceptance / satisfaction index reported by the participants in the transdiagnostic intervention program via the internet compared to the CBT intervention and with the group without treatment.
- It will be found that emotional regulation functions as moderating variables of clinical change.
- The changes will be maintained for three and six months after the end of the transdiagnosis intervention program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- A randomized controlled study will be carried out, following the guidelines set forth in the CONSORT statement (http://www.consort-statement.org) and CONSORT EHealth ( https://www.jmir.org/2011/4/e126/ ). An experimental design between subjects with three independent groups will be used, with within-subject measurements at four evaluation moments: pretest, posttest, follow-up at 3 and 6 months (Solomon Solomon, Cavanaugh \& Draine, 2009). Participants will be randomly assigned to one of three conditions: (a) transdiagnostic intervention via the Internet; (b) Cognitive-Behavior Therapy via the Internet; (c) waiting list control.
| Arm | Type | Receives |
|---|---|---|
| transdiagnostic intervention via the Internet | Experimental | Behavioral: Transdiagnostic online interventionTreatment 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. |
| TCC intervention via the Internet | Active comparator | Behavioral: TCC online interventionThe TCC intervention program is short, with active, focused and directive participation, in 8 individual weekly sessions of one hour by videoconference. |
| waiting list control. | No 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- be of legal age;
- voluntarily participate in the study;
- meet diagnostic criteria for emotional disorders (anxiety or depression) according to the International Neuropsychiatric Interview- Mini, version 5.0, and show a score ≤ 25 on the Beck Anxiety Depression Inventory and / or ≤ 30 on the Inventory Depression of Beck-BDI-II,
- have access to a computer equipment with an Internet connection, (e) have a valid email address, (f) have basic digital skills in the use of a system operating and internet browsing.
Key exclusion criteria (7 listed)
- psychotic disorder;
- alcohol and drug abuse;
- medical illness whose severity or characteristics prevent the performance of the intervention;
- be receiving psychological and / or pharmacological treatment during the study.
- not accepting the conditions of informed consent
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 |
|---|---|---|
| Transdiagnostic online interventionBased 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. | Behavioural | transdiagnostic intervention via the Internet |
| TCC online interventionThis 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. | Behavioural | TCC intervention via the Internet |
Primary outcome
Decrease in the score of Beck Anxiety Inventory
Time frame: 9 weeks
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).
Decrease in the score of Beck Depression Inventory
Time frame: 9 weeks
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)
Decrease in the score of Checkable List of Post-Traumatic Stress Disorder for DSM-5 (PCL-5)
Time frame: 9 weeks
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).
Decrease in the score of Scale of Difficulties in Emotional Regulation
Time frame: 9 weeks
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.
1 secondary outcome
Increase the level of acceptance and satisfaction of psychological treatment
Time frame: 9 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2021.
- Background: PubMed 26652054Andersson G. Internet-Delivered Psychological Treatments. Annu Rev Clin Psychol. 2016;12:157-79. doi: 10.1146/annurev-clinpsy-021815-093006. Epub 2015 Dec 11.
- Background: PubMed 20967242Andrews G, Cuijpers P, Craske MG, McEvoy P, Titov N. Computer therapy for the anxiety and depressive disorders is effective, acceptable and practical health care: a meta-analysis. PLoS One. 2010 Oct 13;5(10):e13196. doi: 10.1371/journal.pone.0013196.
- Background: PubMed 27993336Barlow 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.
- BackgroundCárdenas, G., Botella, C., Quero, S., De la Rosa, A. & Baños, R. Programa de Telepsicología para el Tratamiento de la Fobia a hablar en público en Población Mexicana. Revista Psicología Iberoamericana. 2014; 22 (1): 45-54.
- BackgroundCárdenas, G., Flores, L. y De la Rosa, A. Psicoterapia vía Internet: Manual de entrenamiento. Facultad de Psicología de la UNAM. DGAPA. 2012. ISBN-978-606-02-2263-4.
- Background: PubMed 33762811Ellard KK, Fairholme CP, Boisseau CL, Farchione TJ, Barlow DH. Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders: Protocol Development and Initial Outcome Data. Cogn Behav Pract. 2010 Feb;17(1):88-101. doi: 10.1016/j.cbpra.2009.06.002. Epub 2010 Jan 29.
- Individual participant dataSharing planned: 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.
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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.
Alejandrina Hernández-Posadas, PhD student study chair
Faculty of Higher Studies Iztacala, National Autonomous University of Mexico
Pablo D Valencia, PhD student study chair
Faculty of Higher Studies Iztacala, National Autonomous University of Mexico
Carolina Santillán-Torres Torija, PhD study chair
Faculty of Higher Studies Iztacala, National Autonomous University of 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 Transdiagnostic online intervention and TCC online intervention in people with Emotional Disorder and Stress Related Disorder, run by Universidad Nacional Autonoma de Mexico 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 4 inclusion and 7 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 18 Oct 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?
Contact Anabel De la Rosa-Gómez, PhD (525556231344, 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 4 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 NCT05081830, which also lists 6 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 18 Oct 2021.