MedDataX Logo

Online Transdiagnostic Intervention for Emotional Disorders and Stress-related Disorders

NCT ID: NCT05081830

Last Updated: 2021-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

159 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-01

Study Completion Date

2022-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Emotional Disorder Stress Related Disorder Anxiety Disorders Depression

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Transdiagnostic online intervention

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

TCC online intervention

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Universidad Nacional Autonoma de Mexico

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Anabel De La Rosa Gomez

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Alejandrina Hernández-Posadas, PhD student

Role: STUDY_CHAIR

Faculty of Higher Studies Iztacala, National Autonomous University of Mexico

Pablo D Valencia, PhD student

Role: STUDY_CHAIR

Faculty of Higher Studies Iztacala, National Autonomous University of Mexico

Carolina Santillán-Torres Torija, PhD

Role: STUDY_CHAIR

Faculty of Higher Studies Iztacala, National Autonomous University of Mexico

Paulina Arenas-Landgrave, PhD

Role: STUDY_CHAIR

Faculty of Psychology, National Autonomous University of Mexico

Berenice Serrano-Zarate, PhD

Role: STUDY_CHAIR

Universitat Jaume I

Alejandro Domínguez-Rodríguez, PhD

Role: STUDY_CHAIR

Valencian International University

Mario F Vázquez-Sánchez, Ms student

Role: STUDY_CHAIR

Faculty of Higher Studies Iztacala, National Autonomous University of Mexico

Alicia I Flores-Elvira, Ms

Role: STUDY_CHAIR

Faculty of Higher Studies Iztacala, National Autonomous University of Mexico

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Faculty of Higher Studies Iztacala, National Autonomous University of Mexico

Tlalnepantla, State of Mexico, Mexico, Mexico

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Mexico

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Anabel De la Rosa-Gómez, PhD

Role: CONTACT

[email protected]
525556231344

Lorena A Flores-Plata, PhD

Role: CONTACT

[email protected]
525556231344

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Anabel De la Rosa-Gómez, PhD

Role: primary

[email protected]

Lorena A Flores-Plata, PhD

Role: backup

[email protected]

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 26652054 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20967242 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27993336 (View on PubMed)

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.

Reference Type 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.

Reference Type 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.

Reference Type BACKGROUND
PMID: 33762811 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Informed Consent Form

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

UNAM_FESI_IT300721

Identifier Type: -

Identifier Source: org_study_id