Clinical trial NCT06183333: Efficacy of a Web-Based Emotion Regulation Training in a Transdiagnostic Sample
Official title: Efficacy of a Web-Based Emotion Regulation Training in a Transdiagnostic Sample: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Emotion Regulation
Anxiety Disorders
Depression
Eating Disorders
Borderline Personality Disorder
Keywords: Internet-Based Intervention
Web-Based Training
Emotion Regulation
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2023-12-27
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial with an Intervention Group and a Waiting List Control Group
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in Emotion Regulation Difficulties
timeFrame: 0 weeks, 4 weeks, 8 weeks
Secondary outcomes:
measure: Changes in Emotion Regulation Strategy Use
timeFrame: 0 weeks, 4 weeks, 8 weeks
measure: Changes in Well-Being
timeFrame: 0 weeks, 4 weeks, 8 weeks
measure: Changes in Anxiety Symptoms
timeFrame: 0 weeks, 4 weeks, 8 weeks
measure: Changes in Depressive Symptoms
timeFrame: 0 weeks, 4 weeks, 8 weeks
measure: Changes in Eating Psychopathology
timeFrame: 0 weeks, 4 weeks, 8 weeks
measure: Changes in Personality Pathology
timeFrame: 0 weeks, 4 weeks, 8 weeks
measure: Changes in Eating-Disorder-Related Daily Difficulties
timeFrame: 0 weeks, 4 weeks, 8 weeks
measure: Changes in Self-Esteem
timeFrame: 0 weeks, 4 weeks, 8 weeks
measure: Changes in Weekly Emotion Regulation Strategy Use
timeFrame: 0 weeks, 1 weeks, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 8 weeks
measure: Changes in Weekly Positive and Negative Affect
timeFrame: 0 weeks, 1 weeks, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 8 weeks
measure: Changes in Weekly Eating Psychopathology
timeFrame: 0 weeks, 1 weeks, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 8 weeks
Other outcomes:
measure: Implicit Emotion Regulation Capacity
timeFrame: 4 weeks
measure: Negative Emotion Downregulation Ability
timeFrame: 4 weeks
measure: Positive Emotion Upregulation Ability
timeFrame: 4 weeks
Locations:
city: Heidelberg
country: Germany
facility: Heidelberg University
state: Baden-Württemberg
Study officials:
affiliation: Department of Psychology, Heidelberg University
name: Steffen Hartmann
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Psychology, Heidelberg University
name: Luise Pruessner
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Psychology, Heidelberg University
name: Sven Barnow, PhD
role: STUDY_CHAIR
affiliation: Department of Psychology, Heidelberg University
name: Daniel V. Holt, PhD
role: STUDY_CHAIR
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