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

December 13, 2023 updated by: Luise Pruessner, Heidelberg University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

250

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

  • Germany
    • Baden-Württemberg
      • Heidelberg, Baden-Württemberg, Germany, 69117
        • Recruiting
        • Heidelberg University

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
Web-based emotion regulation intervention
Behavioral: Heidelberg Emotion Regulation Training
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.
No Intervention: Waitlist control group
Eight-week waiting period

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Emotion Regulation Difficulties
Time Frame: 0 weeks, 4 weeks, 8 weeks
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
Time Frame: 0 weeks, 4 weeks, 8 weeks
The Heidelberg Form for Emotion Regulation Strategies (HFERST; Izadpanah et al., 2019)
0 weeks, 4 weeks, 8 weeks
Changes in Well-Being
Time Frame: 0 weeks, 4 weeks, 8 weeks
The World Health Organization Well-Being Index (WHO-5; Topp et al., 2015)
0 weeks, 4 weeks, 8 weeks
Changes in Anxiety Symptoms
Time Frame: 0 weeks, 4 weeks, 8 weeks
The General Anxiety Disorder Scale (GAD-7; Spitzer et al., 2006)
0 weeks, 4 weeks, 8 weeks
Changes in Depressive Symptoms
Time Frame: 0 weeks, 4 weeks, 8 weeks
The Patient Health Questionnaire (PHQ-9; Kroenke et al., 2001)
0 weeks, 4 weeks, 8 weeks
Changes in Eating Psychopathology
Time Frame: 0 weeks, 4 weeks, 8 weeks
The Eating Disorders Examination Questionnaire (EDE-Q; Berg et al., 2012)
0 weeks, 4 weeks, 8 weeks
Changes in Personality Pathology
Time Frame: 0 weeks, 4 weeks, 8 weeks
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
Time Frame: 0 weeks, 4 weeks, 8 weeks
The Clinical Impairment Assessment Questionnaire (CIA; Bohn et al., 2008)
0 weeks, 4 weeks, 8 weeks
Changes in Self-Esteem
Time Frame: 0 weeks, 4 weeks, 8 weeks
The Rosenberg Self-Esteem Scale (RSES; Roth et al., 2008)
0 weeks, 4 weeks, 8 weeks
Changes in Weekly Emotion Regulation Strategy Use
Time Frame: 0 weeks, 1 weeks, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 8 weeks
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
Time Frame: 0 weeks, 1 weeks, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 8 weeks
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
Time Frame: 0 weeks, 1 weeks, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 8 weeks
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implicit Emotion Regulation Capacity
Time Frame: 4 weeks
Responses to negative images (corrugator electromyogram, frontal alpha asymmetry, affect ratings) and heart rate variability during a laboratory resting period (Thayer & Lane, 2000)
4 weeks
Negative Emotion Downregulation Ability
Time Frame: 4 weeks
Changes in responses to negative images (corrugator electromyogram, frontal alpha asymmetry, affect ratings) following a downregulation instruction in a laboratory emotion regulation task (adapted from Ertl et al., 2013)
4 weeks
Positive Emotion Upregulation Ability
Time Frame: 4 weeks
Changes in responses to positive images (corrugator electromyogram, frontal alpha asymmetry, affect ratings) following an upregulation instruction in a laboratory emotion regulation task (adapted from Cheng et al., 2023)
4 weeks

Collaborators and Investigators

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

Sponsor

Heidelberg University

Investigators

  • Principal Investigator: Luise Pruessner, Department of Psychology, Heidelberg University
  • Principal Investigator: Steffen Hartmann, Department of Psychology, Heidelberg University
  • Study Chair: Sven Barnow, PhD, Department of Psychology, Heidelberg University
  • Study Chair: Daniel V. Holt, PhD, Department of Psychology, Heidelberg University

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 (Actual)

May 1, 2023

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

December 13, 2023

First Submitted That Met QC Criteria

December 13, 2023

First Posted (Estimated)

December 27, 2023

Study Record Updates

Last Update Posted (Estimated)

December 27, 2023

Last Update Submitted That Met QC Criteria

December 13, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ER-Training

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified dataset

IPD Sharing Time Frame

Data will be made available after the publication of the study results.

IPD Sharing Access Criteria

Open access, available upon request to ensure appropriate use.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

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.

Clinical Trials on Depression

Clinical Trials on Heidelberg Emotion Regulation Training

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in New Zealand

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe