Online Transdiagnostic Intervention for Emotional Disorders and Stress-related Disorders

October 4, 2021 updated by: Anabel De La Rosa Gomez, Universidad Nacional Autonoma de Mexico

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

159

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. be of legal age;
  2. voluntarily participate in the study;
  3. 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,
  4. 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.

Exclusion Criteria:

  1. psychotic disorder;
  2. alcohol and drug abuse;
  3. medical illness whose severity or characteristics prevent the performance of the intervention;
  4. be receiving psychological and / or pharmacological treatment during the study.

Elimination criteria:

  1. not accepting the conditions of informed consent
  2. absence in two consecutive sessions to the synchronous treatment sessions.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: transdiagnostic intervention via the Internet
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
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.
Active Comparator: TCC intervention via the Internet
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
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.
No Intervention: waiting list control.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decrease in the score of Beck Anxiety Inventory
Time Frame: 9 weeks
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
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)
9 weeks
Decrease in the score of Checkable List of Post-Traumatic Stress Disorder for DSM-5 (PCL-5)
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).
9 weeks
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. Version validated into Spanish by De la Rosa et al. (2021). Presents Cronbach's alpha between .84-.74.
9 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
9 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Nacional Autonoma de Mexico

Investigators

  • Study Chair: 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, Jaume I University
  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2021

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

October 4, 2021

First Submitted That Met QC Criteria

October 4, 2021

First Posted (Actual)

October 18, 2021

Study Record Updates

Last Update Posted (Actual)

October 18, 2021

Last Update Submitted That Met QC Criteria

October 4, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UNAM_FESI_IT300721

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

IPD Sharing 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.

IPD Sharing Access Criteria

Open access saving personal and sensitive data of the participants.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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