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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06183333
Enrollment
250
Registered
2023-12-27
Start date
2023-05-01
Completion date
2025-08-31
Last updated
2023-12-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

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.

Interventions

BEHAVIORALHeidelberg 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.

Sponsors

Heidelberg University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Masking description

Clinical interviews and data analysis will be conducted blindly.

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in Emotion Regulation Difficulties0 weeks, 4 weeks, 8 weeksThe Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2004)

Secondary

MeasureTime frameDescription
Changes in Eating Psychopathology0 weeks, 4 weeks, 8 weeksThe Eating Disorders Examination Questionnaire (EDE-Q; Berg et al., 2012)
Changes in Weekly Emotion Regulation Strategy Use0 weeks, 1 weeks, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 8 weeksWeekly assessment of emotion regulation strategies (adapted from Pruessner et al., 2023).
Changes in Weekly Positive and Negative Affect0 weeks, 1 weeks, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 8 weeksPositive and Negative Affect Schedule - Expanded Form (16 items; PANAS-X; Watson & Clark, 1994)
Changes in Weekly Eating Psychopathology0 weeks, 1 weeks, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 8 weeksThe Eating Disorders Examination Questionnaire (EDE-QS; Gideon et al., 2016)
Changes in Emotion Regulation Strategy Use0 weeks, 4 weeks, 8 weeksThe Heidelberg Form for Emotion Regulation Strategies (HFERST; Izadpanah et al., 2019)
Changes in Well-Being0 weeks, 4 weeks, 8 weeksThe World Health Organization Well-Being Index (WHO-5; Topp et al., 2015)
Changes in Anxiety Symptoms0 weeks, 4 weeks, 8 weeksThe General Anxiety Disorder Scale (GAD-7; Spitzer et al., 2006)
Changes in Depressive Symptoms0 weeks, 4 weeks, 8 weeksThe Patient Health Questionnaire (PHQ-9; Kroenke et al., 2001)
Changes in Personality Pathology0 weeks, 4 weeks, 8 weeksThe Personality Inventory for DSM-5 (PID-5; Krueger et al., 2012)
Changes in Eating-Disorder-Related Daily Difficulties0 weeks, 4 weeks, 8 weeksThe Clinical Impairment Assessment Questionnaire (CIA; Bohn et al., 2008)
Changes in Self-Esteem0 weeks, 4 weeks, 8 weeksThe Rosenberg Self-Esteem Scale (RSES; Roth et al., 2008)

Other

MeasureTime frameDescription
Positive Emotion Upregulation Ability4 weeksChanges 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)
Implicit Emotion Regulation Capacity4 weeksResponses to negative images (corrugator electromyogram, frontal alpha asymmetry, affect ratings) and heart rate variability during a laboratory resting period (Thayer & Lane, 2000)
Negative Emotion Downregulation Ability4 weeksChanges 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)

Countries

Germany

Contacts

Primary ContactSteffen Hartmann
steffen.hartmann@psychologie.uni-heidelberg.de+496221 / 54 7295
Backup ContactLuise Pruessner
luise.pruessner@psychologie.uni-heidelberg.de+49 6221 / 54 7282

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026