Efficacy of a Web-Based Emotion Regulation Intervention for Patients With Congenital Heart Disease

Summary

Congenital heart disease (CHD) is associated with daily stressors and functional impairments that can cause negative emotions. Emotion regulation abilities may determine whether people with CHD develop psychopathology or adapt to the illness-related regulatory demands. This three-arm randomized clinical trial evaluates the efficacy of emotion regulation interventions in individuals with CHD.

Patients with CHD over 18 years will be randomly assigned to a CHD-specific web-based emotion regulation intervention, a general web-based emotion regulation intervention, or a waitlist control group with delayed intervention access (8 weeks). The interventions are based on cognitive behavioral therapy, including everyday emotion regulation exercises and psychoeducation via video and audio files. Four and eight weeks after baseline, emotion regulation, well-being, depression, anxiety, perceived stress, life satisfaction, and illness identity will be assessed.

Both interventions are expected to improve emotion regulation abilities, well-being, depressive symptoms, anxiety, perceived stress, life satisfaction, and illness identity four and eight weeks after baseline compared to the waitlist control group. The disease-specific intervention is hypothesized to be superior as it targets everyday emotional problems in CHD patients.

Conditions

• Congenital Heart Disease
• Emotional Regulation

Interventions

OTHER

CHD-specific web-based emotion regulation intervention

CHD-specific web-based emotion regulation intervention with ten video-based sessions covering emotional challenges of CHD and effective emotion regulation strategies (i.e., reappraisal, acceptance, problem solving, distraction, rumination, avoidance, suppression). To integrate the intervention into emotional experiences occurring in the daily life of patients with CHD, the sessions are supported by everyday emotion regulation exercises using an ecological momentary intervention.

OTHER

General web-based emotion regulation intervention

General web-based emotion regulation intervention with ten video-based sessions covering topics related to emotional awareness and effective emotion regulation strategies (i.e., reappraisal, acceptance, problem solving, distraction, rumination, avoidance, suppression). To integrate the intervention into emotional experiences occurring in daily life, the sessions are supported by everyday emotion regulation exercises using an ecological momentary intervention.

Sponsors & Collaborators

• Competence Network for Congenital Heart Defects

  collaborator OTHER_GOV

• Heidelberg University

  lead OTHER

Principal Investigators

• Luise Pruessner · Department of Psychology, Heidelberg University, Heidelberg (Germany)

• Steffen Hartmann · Department of Psychology, Heidelberg University, Heidelberg (Germany)

• Anna-Lena Ehmann · Department of Psychology, Heidelberg University, Heidelberg (Germany)

• Sven Barnow · Department of Psychology, Heidelberg University, Heidelberg (Germany)

• Ulrike Bauer · National Register for Congenital Heart Defects, Berlin (Germany)

• Paul Helm · National Register for Congenital Heart Defects, Berlin (Germany)

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-08-05

Primary Completion

2024-10-21

Completion

2024-10-21

Countries

• Germany

Study Locations