Clinical trial NCT05081830: Online Transdiagnostic Intervention for Emotional Disorders and Stress-related Disorders
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Emotional Disorder
Stress Related Disorder
Anxiety Disorders
Depression
Keywords: online therapy
e-therapy
mexican population
adults
transdiagnostic intervention
Lead sponsor: Universidad Nacional Autonoma de Mexico
Sponsor class: OTHER
First posted: 2021-10-18
Enrollment: 159
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

1. be of legal age;
2. voluntarily participate in the study;
3. 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,
4. 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.

Exclusion Criteria:

1. psychotic disorder;
2. alcohol and drug abuse;
3. medical illness whose severity or characteristics prevent the performance of the intervention;
4. be receiving psychological and / or pharmacological treatment during the study.

Elimination criteria:

1. not accepting the conditions of informed consent
2. absence in two consecutive sessions to the synchronous treatment sessions.

Primary outcomes:
measure: Decrease in the score of Beck Anxiety Inventory
timeFrame: 9 weeks
measure: Decrease in the score of Beck Depression Inventory
timeFrame: 9 weeks
measure: Decrease in the score of Checkable List of Post-Traumatic Stress Disorder for DSM-5 (PCL-5)
timeFrame: 9 weeks
measure: Decrease in the score of Scale of Difficulties in Emotional Regulation
timeFrame: 9 weeks
Secondary outcomes:
measure: Increase the level of acceptance and satisfaction of psychological treatment
timeFrame: 9 weeks
Other outcomes:
Locations:
city: Tlalnepantla
country: Mexico
facility: Faculty of Higher Studies Iztacala, National Autonomous University of Mexico
state: State Of Mexico, Mexico
Study officials:
affiliation: Faculty of Higher Studies Iztacala, National Autonomous University of Mexico
name: Alejandrina Hernández-Posadas, PhD student
role: STUDY_CHAIR
affiliation: Faculty of Higher Studies Iztacala, National Autonomous University of Mexico
name: Pablo D Valencia, PhD student
role: STUDY_CHAIR
affiliation: Faculty of Higher Studies Iztacala, National Autonomous University of Mexico
name: Carolina Santillán-Torres Torija, PhD
role: STUDY_CHAIR
affiliation: Faculty of Psychology, National Autonomous University of Mexico
name: Paulina Arenas-Landgrave, PhD
role: STUDY_CHAIR
affiliation: Universitat Jaume I
name: Berenice Serrano-Zarate, PhD
role: STUDY_CHAIR
affiliation: Valencian International University
name: Alejandro Domínguez-Rodríguez, PhD
role: STUDY_CHAIR
affiliation: Faculty of Higher Studies Iztacala, National Autonomous University of Mexico
name: Mario F Vázquez-Sánchez, Ms student
role: STUDY_CHAIR
affiliation: Faculty of Higher Studies Iztacala, National Autonomous University of Mexico
name: Alicia I Flores-Elvira, Ms
role: STUDY_CHAIR
References:
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citation: Andrews 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.
citation: 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.
citation: Cárdenas, 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.
citation: 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.
citation: 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.