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

NCT05225701 | Unknown DMC

• 1 other identifier: UNAM_FESI_CONACYT_1401
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 6

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.

Conditions

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

Keywords

Transdiagnostic intervention; Guided Internet-Delivered intervention; Mexican population; Adults; Telepsychology; Internet-based treatment

Outcome Measures

Primary Outcomes (6)

• Decrease in the score of Beck Anxiety Inventory

  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).

  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). 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.

  9 weeks

• Decrease in the score of Post-Traumatic Stress Disorder Checklist

  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.

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

  9 weeks

• Decrease frequency, severity and avoidance of anxiety

  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).

  9 weeks

• Decrease frequency and severity of depression

  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).

  9 weeks

Secondary Outcomes (1)

• Increase the level of acceptance and satisfaction of psychological treatment

  9 weeks

Study Arms (3)

Transdiagnostic guided internet-delivered intervention with synchronous assistance

EXPERIMENTAL

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

Transdiagnostic self-guided internet-delivered intervention

ACTIVE COMPARATOR

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

waiting list

NO INTERVENTION

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.

Interventions

Transdiagnostic guided internet-delivered intervention with synchronous assistance BEHAVIORAL

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.

Transdiagnostic guided internet-delivered intervention with synchronous assistance

Transdiagnostic self-guided internet-delivered intervention BEHAVIORAL

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.

Transdiagnostic self-guided internet-delivered intervention

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Nacional Autonoma de Mexico: lead
• National Council of Science and Technology, Mexico: collaborator

Study Sites (6)

Autonomous University of Ciudad Juarez

Ciudad Juárez, Chihuahua, 32300, Mexico

Location

Autonomous University of Baja California

Tijuana, Estado de Baja California, 22260, Mexico

Location

Instituto Tecnológico de Sonora

Ciudad Obregón, Sonora, 85000, Mexico

Location

Faculty of Higher Studies Iztacala, National Autonomous University of Mexico

Tlalnepantla, State of Mexico, Mexico, 54090, Mexico

Location

Comprehensive Mental Health Center, Ministry of Health of Tlaxcala

Santa Ana Chiautempan, Tlaxcala, 90800, Mexico

Location

Faculty of Psychology, National Autonomous University of Mexico

Mexico City, 04510, Mexico

Location

Related Publications (7)

• 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.

  PMID: 26652054 BACKGROUND

• 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.

  PMID: 27993336 BACKGROUND

• Health Quality Ontario. Internet-Delivered Cognitive Behavioural Therapy for Major Depression and Anxiety Disorders: A Health Technology Assessment. Ont Health Technol Assess Ser. 2019 Feb 19;19(6):1-199. eCollection 2019.

  PMID: 30873251 BACKGROUND

• Dominguez-Rodriguez A, De La Rosa-Gomez A, Hernandez Jimenez MJ, Arenas-Landgrave P, Martinez-Luna SC, Alvarez Silva J, Garcia Hernandez JE, Arzola-Sanchez C, Acosta Guzman V. A Self-Administered Multicomponent Web-Based Mental Health Intervention for the Mexican Population During the COVID-19 Pandemic: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2020 Nov 16;9(11):e23117. doi: 10.2196/23117.

  PMID: 33196449 BACKGROUND

• Dominguez-Rodriguez A, Martinez-Luna SC, Hernandez Jimenez MJ, De La Rosa-Gomez A, Arenas-Landgrave P, Esquivel Santovena EE, Arzola-Sanchez C, Alvarez Silva J, Solis Nicolas AM, Colmenero Guadian AM, Ramirez-Martinez FR, Vargas ROC. A Self-Applied Multi-Component Psychological Online Intervention Based on UX, for the Prevention of Complicated Grief Disorder in the Mexican Population During the COVID-19 Outbreak: Protocol of a Randomized Clinical Trial. Front Psychol. 2021 Mar 29;12:644782. doi: 10.3389/fpsyg.2021.644782. eCollection 2021.

  PMID: 33854466 BACKGROUND

• Ontario Health (Quality). Internet-Delivered Cognitive Behavioural Therapy for Post-traumatic Stress Disorder or Acute Stress Disorder: A Health Technology Assessment. Ont Health Technol Assess Ser. 2021 Jun 1;21(9):1-120. eCollection 2021.

  PMID: 34527087 BACKGROUND

• de la Rosa-Gomez A, Flores-Plata LA, Esquivel-Santovena EE, Santillan Torres Torija C, Garcia-Flores R, Dominguez-Rodriguez A, Arenas-Landgrave P, Castellanos-Vargas RO, Berra-Ruiz E, Silvestre-Ramirez R, Miranda-Diaz GA, Diaz-Sosa DM, Hernandez-Posadas A, Flores-Elvira AI, Valencia PD, Vazquez-Sanchez MF. Efficacy of a transdiagnostic guided internet-delivered intervention for emotional, trauma and stress-related disorders in Mexican population: study protocol for a randomized controlled trial. BMC Psychiatry. 2022 Aug 9;22(1):537. doi: 10.1186/s12888-022-04132-6.

  PMID: 35941557 DERIVED

MeSH Terms

Conditions

Trauma and Stressor Related Disorders; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• 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 CHAIR

Central Study Contacts

Anabel De la Rosa-Gómez, PhD

CONTACT

525537346590; anabel.delarosa@iztacala.unam.mx

Lorena A Flores-Plata, PhD

CONTACT

525556231344; lorena.flores@iztacala.unam.mx

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: January 25, 2022
• First Posted: February 4, 2022
• Study Start: September 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2023
• Last Updated: February 4, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, 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.

Locations

ME (6)