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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06183333
• Other study ID #: ER-Training
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: August 2025

Study information

• Verified date: December 2023
• Source: Heidelberg University
• Contact: Steffen Hartmann
• Phone: +496221 / 54 7295
• Email: steffen.hartmann[@]psychologie.uni-heidelberg.de
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: August 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

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.

Locations

Country	Name	City	State
Germany	Heidelberg University	Heidelberg	Baden-Württemberg

Sponsors (1)

Lead Sponsor	Collaborator
Heidelberg University

Country where clinical trial is conducted

Germany, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Implicit Emotion Regulation Capacity	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
Other	Negative Emotion Downregulation Ability	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
Other	Positive Emotion Upregulation Ability	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
Primary	Changes in Emotion Regulation Difficulties	The Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2004)	0 weeks, 4 weeks, 8 weeks
Secondary	Changes in Emotion Regulation Strategy Use	The Heidelberg Form for Emotion Regulation Strategies (HFERST; Izadpanah et al., 2019)	0 weeks, 4 weeks, 8 weeks
Secondary	Changes in Well-Being	The World Health Organization Well-Being Index (WHO-5; Topp et al., 2015)	0 weeks, 4 weeks, 8 weeks
Secondary	Changes in Anxiety Symptoms	The General Anxiety Disorder Scale (GAD-7; Spitzer et al., 2006)	0 weeks, 4 weeks, 8 weeks
Secondary	Changes in Depressive Symptoms	The Patient Health Questionnaire (PHQ-9; Kroenke et al., 2001)	0 weeks, 4 weeks, 8 weeks
Secondary	Changes in Eating Psychopathology	The Eating Disorders Examination Questionnaire (EDE-Q; Berg et al., 2012)	0 weeks, 4 weeks, 8 weeks
Secondary	Changes in Personality Pathology	The Personality Inventory for DSM-5 (PID-5; Krueger et al., 2012)	0 weeks, 4 weeks, 8 weeks
Secondary	Changes in Eating-Disorder-Related Daily Difficulties	The Clinical Impairment Assessment Questionnaire (CIA; Bohn et al., 2008)	0 weeks, 4 weeks, 8 weeks
Secondary	Changes in Self-Esteem	The Rosenberg Self-Esteem Scale (RSES; Roth et al., 2008)	0 weeks, 4 weeks, 8 weeks
Secondary	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
Secondary	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
Secondary	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