Online Transdiagnostic Intervention for Emotional Disorders and Stress-related Disorders

NCT05081830 | Unknown DMC

• 1 other identifier: UNAM_FESI_IT300721
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 1

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.

Conditions

Emotional Disorder; Stress Related Disorder; Anxiety Disorders; Depression

Keywords

online therapy; e-therapy; mexican population; adults; transdiagnostic intervention

Outcome Measures

Primary Outcomes (4)

• Decrease in the score of Beck Anxiety Inventory

  Beck Anxiety Inventory ( BAI , Beck \& Steer, 1990). Self-applied instrument that consists of 21 questions that determine the severity with which the symptomatic and behavioral categories of anxiety symptoms present in an individual are presented. High internal consistency and adequate construct validity, divergent and convergent (Robles, Varela, Jurado \& Páez, 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)

  9 weeks

• Decrease in the score of Checkable List of Post-Traumatic Stress Disorder for DSM-5 (PCL-5)

  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).

  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. Version validated into Spanish by De la Rosa et al. (2021). Presents Cronbach's alpha between .84-.74.

  9 weeks

Secondary Outcomes (1)

• Increase the level of acceptance and satisfaction of psychological treatment

  9 weeks

Study Arms (3)

transdiagnostic intervention via the Internet

EXPERIMENTAL

Treatment provided in eight individual sessions of 60 min., Once a week by videoconference. The integrity of the treatment will be controlled through the therapist's manual (Barlow et al., 2011) adapted for the Mexican population and to the online modality.

Behavioral: Transdiagnostic online intervention

TCC intervention via the Internet

ACTIVE COMPARATOR

The TCC intervention program is short, with active, focused and directive participation, in 8 individual weekly sessions of one hour by videoconference.

Behavioral: TCC online intervention

waiting list control.

NO INTERVENTION

Participants in the control group on the waiting list will be assigned to the intervention after 2 months after randomization and will join the Transdiagnostic intervention.

Interventions

Transdiagnostic online intervention BEHAVIORAL

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.

transdiagnostic intervention via the Internet

TCC online intervention BEHAVIORAL

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.

TCC intervention via the Internet

Eligibility Criteria

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

You may qualify if:

• be of legal age;
• voluntarily participate in the study;
• 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,
• 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.

You may not qualify if:

• psychotic disorder;
• alcohol and drug abuse;
• medical illness whose severity or characteristics prevent the performance of the intervention;
• be receiving psychological and / or pharmacological treatment during the study.
• Elimination criteria:
• not accepting the conditions of informed consent
• absence in two consecutive sessions to the synchronous treatment sessions.

Sponsors & Collaborators

• Universidad Nacional Autonoma de Mexico: lead

Study Sites (1)

Faculty of Higher Studies Iztacala, National Autonomous University of Mexico

Tlalnepantla, State of Mexico, Mexico, 54090, Mexico

Location

Related Publications (6)

• 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

• 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.

  PMID: 20967242 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

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 33762811 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Alejandrina Hernández-Posadas, PhD student

  Faculty of Higher Studies Iztacala, National Autonomous University of Mexico

  STUDY CHAIR

• Pablo D Valencia, PhD student

  Faculty of Higher Studies Iztacala, National Autonomous University of Mexico

  STUDY CHAIR

• Carolina Santillán-Torres Torija, PhD

  Faculty of Higher Studies Iztacala, National Autonomous University of Mexico

  STUDY CHAIR

• Paulina Arenas-Landgrave, PhD

  Faculty of Psychology, National Autonomous University of Mexico

  STUDY CHAIR

• Berenice Serrano-Zarate, PhD

  Universitat Jaume I

  STUDY CHAIR

• Alejandro Domínguez-Rodríguez, PhD

  Valencian International University

  STUDY CHAIR

• Mario F Vázquez-Sánchez, Ms student

  Faculty of Higher Studies Iztacala, National Autonomous University of Mexico

  STUDY CHAIR

• Alicia I Flores-Elvira, Ms

  Faculty of Higher Studies Iztacala, National Autonomous University of Mexico

  STUDY CHAIR

Central Study Contacts

Anabel De la Rosa-Gómez, PhD

CONTACT

525556231344; 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 of the condition in which he / she will participate in the study (experimental or control waiting list) and, depending on the characteristics of said condition, he / she will be discharged from the study and will put him / her in contact with the advisor who has been assigned to you.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: 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.

Study Record Dates

• First Submitted: October 4, 2021
• First Posted: October 18, 2021
• Study Start: November 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: October 18, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: This data will be available in december 2022 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 (1)