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

NCT06183333 | Unknown

• 1 other identifier: ER-Training
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Emotion Regulation; Anxiety Disorders; Depression; Eating Disorders; Borderline Personality Disorder

Keywords

Internet-Based Intervention; Web-Based Training; Emotion Regulation

Outcome Measures

Primary Outcomes (1)

• Changes in Emotion Regulation Difficulties

  The Difficulties in Emotion Regulation Scale (DERS; Gratz \& Roemer, 2004)

  0 weeks, 4 weeks, 8 weeks

Secondary Outcomes (11)

• Changes in Emotion Regulation Strategy Use

  0 weeks, 4 weeks, 8 weeks

• Changes in Well-Being

  0 weeks, 4 weeks, 8 weeks

• Changes in Anxiety Symptoms

  0 weeks, 4 weeks, 8 weeks

• Changes in Depressive Symptoms

  0 weeks, 4 weeks, 8 weeks

• Changes in Eating Psychopathology

  0 weeks, 4 weeks, 8 weeks

Other Outcomes (3)

• Implicit Emotion Regulation Capacity

  4 weeks

• Negative Emotion Downregulation Ability

  4 weeks

• Positive Emotion Upregulation Ability

  4 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

Web-based emotion regulation intervention

Behavioral: Heidelberg Emotion Regulation Training

Waitlist control group

NO INTERVENTION

Eight-week waiting period

Interventions

Heidelberg Emotion Regulation Training BEHAVIORAL

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.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sufficient German language skills (C1)
• Permanent internet access during the study period
• ≥ 18 years of age

You may not qualify if:

• Acute suicidality
• Current severe substance use disorder
• Current severe depressive episode
• Lifetime bipolar disorder
• Lifetime psychotic disorders
• Body Mass Index (BMI) below 18.5

Sponsors & Collaborators

• Heidelberg University: lead

Study Sites (1)

Heidelberg University

Heidelberg, Baden-Wurttemberg, 69117, Germany

RECRUITING

Related Publications (8)

• 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.

  PMID: 25774638 BACKGROUND

• 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.

  PMID: 28730850 BACKGROUND

• 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.

  PMID: 25831962 BACKGROUND

• 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.

  PMID: 16717171 BACKGROUND

• 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.

  PMID: 11556941 BACKGROUND

• 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.

  PMID: 22279527 BACKGROUND

• 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.

  PMID: 24511899 BACKGROUND

• 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.

  PMID: 32849049 BACKGROUND

MeSH Terms

Conditions

Emotional Regulation; Anxiety Disorders; Depression; Feeding and Eating Disorders; Borderline Personality Disorder

Condition Hierarchy (Ancestors)

Self-Control; Social Behavior; Behavior; Mental Disorders; Behavioral Symptoms; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Personality Disorders

Study Officials

• Steffen Hartmann

  Department of Psychology, Heidelberg University

  PRINCIPAL INVESTIGATOR

• Luise Pruessner

  Department of Psychology, Heidelberg University

  PRINCIPAL INVESTIGATOR

• Sven Barnow, PhD

  Department of Psychology, Heidelberg University

  STUDY CHAIR

• Daniel V. Holt, PhD

  Department of Psychology, Heidelberg University

  STUDY CHAIR

Central Study Contacts

Steffen Hartmann

CONTACT

+496221 / 54 7295; steffen.hartmann@psychologie.uni-heidelberg.de

Luise Pruessner

CONTACT

+49 6221 / 54 7282; luise.pruessner@psychologie.uni-heidelberg.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Clinical interviews and data analysis will be conducted blindly.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized Controlled Trial with an Intervention Group and a Waiting List Control Group

Study Record Dates

• First Submitted: December 13, 2023
• First Posted: December 27, 2023
• Study Start: May 1, 2023
• Primary Completion: June 1, 2025
• Study Completion: August 1, 2025
• Last Updated: December 27, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Data will be made available after the publication of the study results.
• Access Criteria: Open access, available upon request to ensure appropriate use.

Locations

DE (1)