Efficacy of a Web-Based Emotion Regulation Training in a Transdiagnostic Sample
NCT ID: NCT06183333
Last Updated: 2023-12-27
Study Results
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.
RECRUITING
NA
250 participants
INTERVENTIONAL
2023-05-01
2025-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Intervention group
Web-based emotion regulation intervention
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.
Waitlist control group
Eight-week waiting period
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.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Permanent internet access during the study period
* ≥ 18 years of age
Exclusion Criteria
* Current severe substance use disorder
* Current severe depressive episode
* Lifetime bipolar disorder
* Lifetime psychotic disorders
* Body Mass Index (BMI) below 18.5
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Heidelberg University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Luise Pruessner
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Steffen Hartmann
Role: PRINCIPAL_INVESTIGATOR
Department of Psychology, Heidelberg University
Luise Pruessner
Role: PRINCIPAL_INVESTIGATOR
Department of Psychology, Heidelberg University
Sven Barnow, PhD
Role: STUDY_CHAIR
Department of Psychology, Heidelberg University
Daniel V. Holt, PhD
Role: STUDY_CHAIR
Department of Psychology, Heidelberg University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Heidelberg University
Heidelberg, Baden-Wurttemberg, Germany
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
References
Explore related publications, articles, or registry entries linked to this study.
Ritschel LA, Tone EB, Schoemann AM, Lim NE. Psychometric properties of the Difficulties in Emotion Regulation Scale across demographic groups. Psychol Assess. 2015 Sep;27(3):944-54. doi: 10.1037/pas0000099. Epub 2015 Mar 16.
Izadpanah S, Barnow S, Neubauer AB, Holl J. Development and Validation of the Heidelberg Form for Emotion Regulation Strategies (HFERST): Factor Structure, Reliability, and Validity. Assessment. 2019 Jul;26(5):880-906. doi: 10.1177/1073191117720283. Epub 2017 Jul 21.
Topp CW, Ostergaard SD, Sondergaard S, Bech P. The WHO-5 Well-Being Index: a systematic review of the literature. Psychother Psychosom. 2015;84(3):167-76. doi: 10.1159/000376585. Epub 2015 Mar 28.
Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
Hilbert A, de Zwaan M, Braehler E. How frequent are eating disturbances in the population? Norms of the eating disorder examination-questionnaire. PLoS One. 2012;7(1):e29125. doi: 10.1371/journal.pone.0029125. Epub 2012 Jan 18.
Zimmermann J, Altenstein D, Krieger T, Holtforth MG, Pretsch J, Alexopoulos J, Spitzer C, Benecke C, Krueger RF, Markon KE, Leising D. The structure and correlates of self-reported DSM-5 maladaptive personality traits: findings from two German-speaking samples. J Pers Disord. 2014 Aug;28(4):518-40. doi: 10.1521/pedi_2014_28_130. Epub 2014 Feb 10.
Roth M, Altmann T. A Comparison of the Predictive Validity of Self-Esteem Level and Directly Measured Self-Esteem Stability in the Temporal Prediction of Psychological Distress. Front Psychol. 2020 Jul 24;11:1770. doi: 10.3389/fpsyg.2020.01770. eCollection 2020.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ER-Training
Identifier Type: -
Identifier Source: org_study_id