Efficacy of a Web-Based Emotion Regulation Training in a Transdiagnostic Sample

Depression Clinical Trial

Official title: Efficacy of a Web-Based Emotion Regulation Training in a Transdiagnostic Sample: A Randomized Controlled Trial

Status Recruiting

Clinical Trial Summary

This two-armed randomized controlled trial investigates the efficacy of a web-based emotion regulation intervention in a transdiagnostic sample. The sample includes participants diagnosed with anxiety disorders, depression, eating disorders, borderline personality disorder, and healthy controls without a current psychiatric diagnosis. Participants will be randomly assigned to either the intervention group, receiving a web-based emotion regulation program, or a waitlist control group, which will have delayed intervention access after eight weeks.

The intervention is grounded in cognitive-behavioral therapy (CBT), featuring everyday emotion regulation exercises, and psychoeducation delivered through video and audio files. Outcome measures include emotion regulation abilities, well-being, anxiety, depression, eating disorder symptoms, personality pathology, and self-esteem, evaluated at four and eight weeks post-baseline.

Clinical Trial Description

Background:

Emotion regulation is pivotal in the pathogenesis and persistence of diverse psychopathologies. While anxiety disorders are often marked by an impaired ability to modulate acute fear responses, depressive disorders feature enduring negative affect and frequent rumination. In eating disorders, emotional dysregulation typically leads to maladaptive coping via disordered eating behaviors, whereas in borderline personality disorder, it manifests as emotional instability. The pervasiveness of emotion regulation difficulties across these diverse clinical presentations highlights a need for treatments targeting this shared mechanism. Our study aims to address this gap by testing the effectiveness of a novel web-based emotion regulation intervention in a transdiagnostic sample.

Method:

This two-armed randomized controlled trial involves participants aged 18 and above diagnosed with anxiety disorders, depression, eating disorders, borderline personality disorder, and healthy controls without psychiatric diagnoses. Participants will be randomly assigned to one of two groups:

1. Web-based emotion regulation intervention.

2. Waitlist control group with delayed intervention access (eight weeks).

The intervention, accessible via mobile phones or desktop browsers, employs cognitive-behavioral therapy (CBT) techniques, offering everyday emotion regulation exercises and psychoeducation through video material and audio files.

Outcome measures, including emotion regulation abilities, well-being, anxiety, depression, eating disorder symptoms, personality pathology, and self-esteem, will be assessed at four and eight weeks post-baseline.

Hypotheses:

The intervention is expected to result in improved emotion regulation abilities and well-being, along with reduced anxiety, depression, eating disorder symptoms, personality pathology, and self-esteem compared to the waitlist control group. The transdiagnostic intervention is anticipated to demonstrate superiority in addressing the diverse emotional challenges across different psychological disorders.

Additional Laboratory Study:

A subgroup of participants will be invited for a follow-up laboratory assessment of physiological indicators of emotion regulation abilities four weeks after their initial baseline measurement. We hypothesize that the intervention will lead to notable improvements in implicit emotion regulation capacity measured during a resting period and the presentation of negative emotional images. Furthermore, we anticipate observable improvements in explicit emotion regulatory skills, specifically in the downregulation of negative emotions and the upregulation of positive emotions, as assessed through a picture-viewing paradigm. ;

Related Conditions & MeSH terms

• Anxiety Disorders
• Borderline Personality Disorder
• Depression
• Eating Disorders
• Emotion Regulation
• Feeding and Eating Disorders
• Personality Disorders

• NCT number: NCT06183333
• Study type: Interventional
• Source: Heidelberg University
• Contact: Steffen Hartmann
• Phone: +496221 / 54 7295
• Email: steffen.hartmann@psychologie.uni-heidelberg.de
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2023
• Completion date: August 2025