We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05225701
Recruitment Status : Not yet recruiting
First Posted : February 4, 2022
Last Update Posted : February 4, 2022
Sponsor:
Collaborator:
National Council of Science and Technology, Mexico
Information provided by (Responsible Party):
Anabel De La Rosa Gomez, Universidad Nacional Autonoma de Mexico

Brief 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.

Condition or disease Intervention/treatment Phase
Emotional Disorder Trauma and Stressor Related Disorders Anxiety Disorders Depression Behavioral: Transdiagnostic guided internet-delivered intervention with synchronous assistance Behavioral: Transdiagnostic self-guided internet-delivered intervention Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 153 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A randomized controlled study will be carried out, in accordance with the guidelines set out in the consort (http://www.consort-statement.org) and CONSORT E-Health (https://www.jmir.org/2011/4/e126/). An experimental design will be used between subjects with three independent groups, with intrasubject measurements in four evaluation moments: pretest, posttest, follow-up at 3, 6 and 12 months (Solomon et al. ,2009). Participants will be randomly assigned to one of three conditions: a) Transdiagnostic guided internet-delivered intervention with synchronous assistance; b) Transdiagnostic self-guided internet-delivered intervention; c) waiting list.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double-blinded: The initial interview by the evaluator will be recorded and the video/audio will be shared with an independent evaluator who does not know the case for evaluation. Once the evaluation is completed, users will be randomly assigned to one of the study conditions. The randomization will be carried out by an independent researcher through the random.stg software in a 1: 1: 1 ratio by saturation of blocks of 12 per condition. The coordinator will inform the participant if he / she will participate in the study and, depending on the characteristics of the study design condition, he / she will be assigned to the self-guided/ guided intervention.
Primary Purpose: Treatment
Official Title: Acceptability, Efficacy and Moderators of Clinical Change of a Transdiagnostic Guided Internet-Delivered Intervention for Emotional, Trauma and Stress-Related Disorders in the Mexican Population: Randomized Controlled Trial
Estimated Study Start Date : September 2022
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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. The duration of the intervention program may vary between users; however, the participant will have access permits for a maximum period of 12 weeks. In order to monitor the participant's progress, each user will be assigned an advisor who will be health personnel (psychologists, social workers, and gerontologists) to get an a weekly personalized synchronous assistance and psychological counseling.
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.

Active Comparator: 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. The duration of the intervention program may vary between users; however, the participant will have access permits for a maximum period of 12 weeks. All modules are sequential, allowing the user to go step by step. This arm does not have personalized online assistance.
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.

No Intervention: waiting list
Participants on the waiting list will be assigned to the intervention after 2 months after randomization and will join the Transdiagnostic guided internet-delivered intervention with synchronous assistance.



Primary Outcome Measures :
  1. Decrease in the score of Beck Anxiety Inventory [ Time Frame: 9 weeks ]
    Beck Anxiety Inventory (BAI , Beck & Steer, 1990). The BAI is a 21-item self-report measure of the severity of common affective, cognitive, and somatic symptoms of anxiety. Items have four response options ranging from 0 "not at all" to 3 "severely". The cut-off points are: 0-5 minimal anxiety, 6-15 mild anxiety, 16-30 moderate anxiety and 31-63 severe anxiety. High internal consistency and adequate construct validity, divergent and convergent for the Mexican version has been documented (Cronbach's alpha = .83) (Robles et al., 2001).

  2. 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). Each statement has four response options that reflect increasing symptom frequency or severity. Total scores can range from 0-63 with the following cut-offs points: 0-13 minimally depressed, 14-19 mildly depressed, 20-28 moderately depressed, and 29-63 severely depressed.

  3. Decrease in the score of Post-Traumatic Stress Disorder Checklist [ 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). Items are scored on a Likert scale ranging from 0 to 4, where higher scores indicate more pronounced PTSD symptoms. A cut-off score of 33 was suggested to have a partial diagnosis of PTSD.

  4. 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. The version validated in Mexican population by De la Rosa et al. (2021), presents a Cronbach's Alpha valued between .84 - .74.

  5. Decrease frequency, severity and avoidance of anxiety [ Time Frame: 9 weeks ]
    General Anxiety and the Impairment Severity Scale (OASIS) (Norman et al., 2011). It consists of 5 questions with a scale of 0 to 4, which measures frequency, severity and avoidance of anxiety in different fields: work / academic interference / family, and deterioration of social and daily life. It has good internal consistency (α = 0.80) and test-retest reliability (k = 0.82). The Spanish version confirmed the factorial structure, reliability and validity data obtained by the original authors: internal consistency in both populations, in general and clinical (α = 0.86) and test-fail reliability (k = 0.84) (Mira et al., 2015).

  6. Decrease frequency and severity of depression [ Time Frame: 9 weeks ]
    General Depression and the Impairment Gravity Scale (ODSIS)(Bentley et al., 2014). This scale evaluates experiences related to depression. It consists of five items with different answer options ranging from 0 to 4 for each item. It measures the frequency and severity of depression, as well as the level of avoidance to work/academic/home interference, and social life. In the Spanish version, the internal consistency has proven to be excellent, with a Cronbach alpha between 0.91 and 0.94 and a good convergent and discriminatory validity (González-Robles et al., 2015).


Secondary Outcome Measures :
  1. Increase the level of acceptance and satisfaction of psychological treatment [ Time Frame: 9 weeks ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

a) be of legal age; b) voluntarily participate in the study; c) meet diagnostic criteria for emotional disorders (anxiety or depression) in accordance with the International Neuropsychiatric Interview- Mini, version 5.0 (Sheehan et al., 2006), and show a score ≤ 25 in Beck's Anxiety Depression Inventory (Beck & Steer,1990) and/or ≤ 30 in the Beck-BDI-II Depression Inventory (Beck, Steer & Brown, 1996); d) have access to computer equipment with an Internet connection; e) have a valid email address; f) have basic digital skills in the use of an operating system and internet browsing.

Exclusion Criteria:

a) psychotic disorder; b) alcohol and drug abuse; c) have active suicidal ideation; d) medical condition whose severity or characteristics prevent the intervention; e) be receiving psychological and/or pharmacological treatment during the study.

Elimination criteria :

a) not accepting the conditions of informed consent and b) absence on web or mobile platform for more than 15 days or having missed two consecutive sessions of synchronous treatment sessions.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05225701


Contacts
Layout table for location contacts
Contact: Anabel De la Rosa-Gómez, PhD 525537346590 anabel.delarosa@iztacala.unam.mx
Contact: Lorena A Flores-Plata, PhD 525556231344 lorena.flores@iztacala.unam.mx

Locations
Layout table for location information
Mexico
Autonomous University of Baja California
Tijuana, Baja California, Mexico, 22260
Contact: Enrique Berra Ruíz, PhD       enrique.berra@uabc.edu.mx   
Sub-Investigator: Agustín J Negrete Cortés, PhD         
Sub-Investigator: Rubén Vagas Jiménez, PhD         
Sub-Investigator: Ana I Brito Sánchez, PhD         
Sub-Investigator: María L García Gomar, PhD         
Principal Investigator: Enrique Berra Ruíz, PhD         
Autonomous University of Ciudad Juarez
Ciudad Juárez, Chihuahua, Mexico, 32300
Contact: Esteban E Esquivel Santoveña, PhD       esteban.esquivel@uacj.mx   
Contact: Rosa O Castellanos Vargas, MA       rosa.castellanos@uacj.mx   
Principal Investigator: Rosa O Castellanos Vargas, MA         
Principal Investigator: Esteban E Esquivel Santoveña, PhD         
Instituto Tecnológico de Sonora
Ciudad Obregón, Sonora, Mexico, 85000
Contact: Raquel García-Flores, PhD       raquel.garcia@itson.edu.mx   
Sub-Investigator: Teresa I Sotelo Quiñonez, PhD         
Sub-Investigator: Alma D Silva Ortega, MA         
Principal Investigator: Christian O Acosta Quiroz, PhD         
Principal Investigator: Raquel García Flores, PhD         
Faculty of Higher Studies Iztacala, National Autonomous University of Mexico
Tlalnepantla, State Of Mexico, Mexico, Mexico, 54090
Contact: Anabel De la Rosa-Gómez, PhD       anabel.delarosa@iztacala.unam.mx   
Principal Investigator: Carolina Santillán-Torres Torija, PhD         
Sub-Investigator: Alicia I Flores-Elvira, MA         
Sub-Investigator: Pablo Valencia, PhD student         
Sub-Investigator: Alejandrina Hernández-Posadas, PhD student         
Sub-Investigator: Mario F Vazquéz-Sánchez, MA student         
Principal Investigator: Anabel De la Rosa-Gómez, PhD         
Principal Investigator: Lorena A Flores-Plata, PhD         
Sub-Investigator: Erick A Medina-Jiménez, MA         
Sub-Investigator: Dulce Díaz-Sosa, PhD         
Comprehensive Mental Health Center, Ministry of Health of Tlaxcala
Chiautempan, Tlaxcala, Mexico, 90800
Contact: Rocío Silvestre Ramírez, MA       silvestrerocio@gmail.com   
Sub-Investigator: Edmundo Martell Ruíz, BA         
Sub-Investigator: Leticia Muñoz Romano, MA         
Sub-Investigator: Perla Alvarado Ruíz, BA         
Sub-Investigator: Yessica I González Rodríguez, BA         
Sub-Investigator: José V Chichino Palafox, BA         
Sub-Investigator: José A Montiel Juárez, BA         
Principal Investigator: Rocío Silvestre Ramírez, MA         
Sub-Investigator: Francisco E Hernández García, BA         
Faculty of Psychology, National Autonomous University of Mexico
Mexico City, Mexico, 04510
Contact: Paulina Arenas Landgrave, PhD       palandgr@unam.mx   
Principal Investigator: Paulina Arenas Landgrave, PhD         
Sponsors and Collaborators
Universidad Nacional Autonoma de Mexico
National Council of Science and Technology, Mexico
Investigators
Layout table for investigator information
Study Chair: Raquel García Flores, PhD Technological Institute of Sonora, Department of Psychology
Study Chair: Enrique Berra Ruiz, PhD Autonomous University of Baja California, Faculty of Health Sciences / Psychology
Study Chair: Esteban E Esquivel Santoveña, PhD Department of Social Sciences, Autonomous University of Ciudad Juárez (UACJ)
Study Chair: Paulina Arenas Landgrave, PhD Faculty of Psychology, National Autonomous University of Mexico
Study Chair: Rocío Silvestre Ramírez, MD Comprehensive Center for Mental Health Tzompantepec, Secretary of Health Tlaxcala
Study Chair: Rosa O Castellanos Vargas, MA Health Sciences, Autonomous University of Ciudad Juárez (UACJ)
Study Chair: Alicia I Flores Elvira, MA Faculty of Higher Studies Iztacala, National Autonomous University of Mexico
Study Chair: Alejandro Domínguez-Rodríguez, PhD International University of Valencia
Study Chair: Carolina Santillán Torrres Torija, PhD Faculty of Higher Studies Iztacala, National Autonomous University of Mexico
  Study Documents (Full-Text)

Documents provided by Anabel De La Rosa Gomez, Universidad Nacional Autonoma de Mexico:
Informed Consent Form  [PDF] December 1, 2021

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Anabel De La Rosa Gomez, Principal Investigator, Universidad Nacional Autonoma de Mexico
ClinicalTrials.gov Identifier: NCT05225701    
Other Study ID Numbers: UNAM_FESI_CONACYT_1401
First Posted: February 4, 2022    Key Record Dates
Last Update Posted: February 4, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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 Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: This data will be available in december 2023 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.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Anabel De La Rosa Gomez, Universidad Nacional Autonoma de Mexico:
Transdiagnostic intervention
Guided Internet-Delivered intervention
Mexican population
Adults
Telepsychology
Internet-based treatment
Additional relevant MeSH terms:
Layout table for MeSH terms
Disease
Wounds and Injuries
Anxiety Disorders
Trauma and Stressor Related Disorders
Pathologic Processes
Mental Disorders