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

Study Overview
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Brief Summary
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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.

Detailed Description
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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: Web-based emotion regulation intervention. 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.

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

Conditions
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Emotion Regulation, Anxiety Disorders, Depression, Eating Disorders, Borderline Personality Disorder

Intervention / Treatment
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* Behavioral: Heidelberg Emotion Regulation Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sufficient German language skills (C1) Permanent internet access during the study period ≥ 18 years of age Exclusion Criteria: Acute suicidality Current severe substance use disorder Current severe depressive episode Lifetime bipolar disorder Lifetime psychotic disorders Body Mass Index (BMI) below 18.5

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Controlled Trial with an Intervention Group and a Waiting List Control Group
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Web-based emotion regulation intervention | Behavioral: Heidelberg Emotion Regulation Training<br>* The four-week intervention program is specifically designed to enhance the participants' emotion regulation. It focuses on developing their skills in accurately recognizing various emotions and effectively applying diverse emotion regulation strategies. To achieve this, the program includes video-based psychoeducation sessions. Alongside these sessions, the program incorporates daily short exercises, each lasting approximately five minutes. These exercises are crafted to help participants practically integrate the concepts and strategies learned from the psychoeducation sessions into their everyday lives. All components of the intervention are accessible through an online platform, ensuring ease of access and flexibility for participants.<br>|
| No Intervention: Waitlist control group<br>Eight-week waiting period | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Emotion Regulation Difficulties | The Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2004) | 0 weeks, 4 weeks, 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Emotion Regulation Strategy Use | The Heidelberg Form for Emotion Regulation Strategies (HFERST; Izadpanah et al., 2019) | 0 weeks, 4 weeks, 8 weeks | 
| Changes in Well-Being | The World Health Organization Well-Being Index (WHO-5; Topp et al., 2015) | 0 weeks, 4 weeks, 8 weeks | 
| Changes in Anxiety Symptoms | The General Anxiety Disorder Scale (GAD-7; Spitzer et al., 2006) | 0 weeks, 4 weeks, 8 weeks | 
| Changes in Depressive Symptoms | The Patient Health Questionnaire (PHQ-9; Kroenke et al., 2001) | 0 weeks, 4 weeks, 8 weeks | 
| Changes in Eating Psychopathology | The Eating Disorders Examination Questionnaire (EDE-Q; Berg et al., 2012) | 0 weeks, 4 weeks, 8 weeks | 
| Changes in Personality Pathology | The Personality Inventory for DSM-5 (PID-5; Krueger et al., 2012) | 0 weeks, 4 weeks, 8 weeks | 
| Changes in Eating-Disorder-Related Daily Difficulties | The Clinical Impairment Assessment Questionnaire (CIA; Bohn et al., 2008) | 0 weeks, 4 weeks, 8 weeks | 
| Changes in Self-Esteem | The Rosenberg Self-Esteem Scale (RSES; Roth et al., 2008) | 0 weeks, 4 weeks, 8 weeks | 
| Changes in Weekly Emotion Regulation Strategy Use | Weekly assessment of emotion regulation strategies (adapted from Pruessner et al., 2023). | 0 weeks, 1 weeks, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 8 weeks | 
| Changes in Weekly Positive and Negative Affect | Positive and Negative Affect Schedule - Expanded Form (16 items; PANAS-X; Watson & Clark, 1994) | 0 weeks, 1 weeks, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 8 weeks | 
| Changes in Weekly Eating Psychopathology | The Eating Disorders Examination Questionnaire (EDE-QS; Gideon et al., 2016) | 0 weeks, 1 weeks, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Internet-Based Intervention, Web-Based Training, Emotion Regulation