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

NCT05225701 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 153

Last updated 2022-02-04

No results posted yet for this study

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 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.

Conditions

  • Emotional Disorder
  • Trauma and Stressor Related Disorders
  • Anxiety Disorders
  • Depression

Interventions

BEHAVIORAL

Transdiagnostic guided internet-delivered intervention with synchronous assistance

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.

BEHAVIORAL

Transdiagnostic self-guided internet-delivered intervention

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.

Sponsors & Collaborators

  • National Council of Science and Technology, Mexico

    collaborator OTHER
  • Universidad Nacional Autonoma de Mexico

    lead OTHER

Principal Investigators

  • Raquel García Flores, PhD · Technological Institute of Sonora, Department of Psychology

  • Enrique Berra Ruiz, PhD · Autonomous University of Baja California, Faculty of Health Sciences / Psychology

  • Esteban E Esquivel Santoveña, PhD · Department of Social Sciences, Autonomous University of Ciudad Juárez (UACJ)

  • Paulina Arenas Landgrave, PhD · Faculty of Psychology, National Autonomous University of Mexico

  • Rocío Silvestre Ramírez, MD · Comprehensive Center for Mental Health Tzompantepec, Secretary of Health Tlaxcala

  • Rosa O Castellanos Vargas, MA · Health Sciences, Autonomous University of Ciudad Juárez (UACJ)

  • Alicia I Flores Elvira, MA · Faculty of Higher Studies Iztacala, National Autonomous University of Mexico

  • Alejandro Domínguez-Rodríguez, PhD · International University of Valencia

  • Carolina Santillán Torrres Torija, PhD · Faculty of Higher Studies Iztacala, National Autonomous University of Mexico

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-30
Primary Completion
2022-12-31
Completion
2023-12-31

Countries

  • Mexico

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05225701 on ClinicalTrials.gov