NCT05081830

Online Transdiagnostic Intervention for Emotional Disorders and Stress-related Disorders

Suitability, Clinical Utility and Acceptability of an Online Transdiagnostic Intervention for Emotional Disorders and Stress-related Disorders in Mexican Sample: A Randomized Clinical Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 159 (estimated)
• Sponsor: Universidad Nacional Autonoma de Mexico · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Emotional Disorder
• Stress Related Disorder
• Anxiety Disorders
• Depression

Interventions

Type	Name	Description
BEHAVIORAL	Transdiagnostic online 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.
BEHAVIORAL	TCC online intervention	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.

Timeline

• Start date: 2021-11-01
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2021-10-18
• Last updated: 2021-10-18

Locations

1 site across 1 country: Mexico