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

NCT05862909 | Completed

• 1 other identifier: ER-CHD
• Study Type: interventional
• Target: 524
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Congenital Heart Disease; Emotional Regulation; Internet-Based Interventions; Emotions

Outcome Measures

Primary Outcomes (1)

• Changes in emotion regulation difficulties

  The Difficulties in Emotion Regulation Scale (DERS; Gratz \& Roemer, 2004) consists of 36 items answered on a 5-point scale. The overall score ranges from 36 to 180. Higher values indicate a higher level of emotion regulation difficulties.

  0 weeks, 4 weeks, 8 weeks

Secondary Outcomes (7)

• Changes in emotion regulation strategy use

  0 weeks, 4 weeks, 8 weeks

• Changes in well-being

  0 weeks, 4 weeks, 8 weeks

• Changes in depressive symptoms

  0 weeks, 4 weeks, 8 weeks

• Changes in anxiety symptoms

  0 weeks, 4 weeks, 8 weeks

• Changes in perceived stress

  0 weeks, 4 weeks, 8 weeks

Study Arms (3)

Intervention group (IG 1)

EXPERIMENTAL

CHD-specific web-based emotion regulation intervention

Other: CHD-specific web-based emotion regulation intervention

Intervention group (IG 2)

ACTIVE COMPARATOR

General web-based emotion regulation intervention

Other: General web-based emotion regulation intervention

Waitlist control group (CG)

NO INTERVENTION

8-week waiting period

Interventions

CHD-specific web-based emotion regulation intervention OTHER

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.

Intervention group (IG 1)

General web-based emotion regulation intervention OTHER

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.

Intervention group (IG 2)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• sufficient German language skills (C1)
• permanent internet access during the study period
• diagnosis of a congenital heart disease
• ≥ 18 years of age

You may not qualify if:

• incapacity to provide informed consent
• acute suicidality

Sponsors & Collaborators

• Heidelberg University: lead
• Competence Network for Congenital Heart Defects: collaborator

Study Sites (1)

Competence Network for Congenital Heart Defects

Berlin, 13353, Germany

Location

Related Publications (9)

• 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

• 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

• 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

• 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

• Oris L, Rassart J, Prikken S, Verschueren M, Goubert L, Moons P, Berg CA, Weets I, Luyckx K. Illness Identity in Adolescents and Emerging Adults With Type 1 Diabetes: Introducing the Illness Identity Questionnaire. Diabetes Care. 2016 May;39(5):757-63. doi: 10.2337/dc15-2559. Epub 2016 Mar 17.

  PMID: 26989179 BACKGROUND

• Klein EM, Brahler E, Dreier M, Reinecke L, Muller KW, Schmutzer G, Wolfling K, Beutel ME. The German version of the Perceived Stress Scale - psychometric characteristics in a representative German community sample. BMC Psychiatry. 2016 May 23;16:159. doi: 10.1186/s12888-016-0875-9.

  PMID: 27216151 BACKGROUND

• 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

• Diener E, Emmons RA, Larsen RJ, Griffin S. The Satisfaction With Life Scale. J Pers Assess. 1985 Feb;49(1):71-5. doi: 10.1207/s15327752jpa4901_13.

  PMID: 16367493 BACKGROUND

• Pruessner L, Hartmann S, Ehmann AL, Barnow S, Bauer UMM, Helm PC. Digital Emotion Regulation Interventions for Patients With Congenital Heart Disease: A Randomized Clinical Trial. JAMA Netw Open. 2025 Oct 1;8(10):e2538813. doi: 10.1001/jamanetworkopen.2025.38813.

  PMID: 41134574 DERIVED

MeSH Terms

Conditions

Heart Defects, Congenital; Emotional Regulation

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Self-Control; Social Behavior; Behavior

Study Officials

• Luise Pruessner

  Department of Psychology, Heidelberg University, Heidelberg (Germany)

  PRINCIPAL INVESTIGATOR

• Steffen Hartmann

  Department of Psychology, Heidelberg University, Heidelberg (Germany)

  PRINCIPAL INVESTIGATOR

• Anna-Lena Ehmann

  Department of Psychology, Heidelberg University, Heidelberg (Germany)

  PRINCIPAL INVESTIGATOR

• Sven Barnow

  Department of Psychology, Heidelberg University, Heidelberg (Germany)

  PRINCIPAL INVESTIGATOR

• Ulrike Bauer

  National Register for Congenital Heart Defects, Berlin (Germany)

  PRINCIPAL INVESTIGATOR

• Paul Helm

  National Register for Congenital Heart Defects, Berlin (Germany)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The group allocation variable will be masked during the data analyses to minimize possible bias concerning the statistical procedure. For this purpose, an independent researcher will delete all information in the dataset indicating the group allocation. Therefore, the evaluator does not know which expression of the group variable represents the CHD-specific intervention, the general intervention, or the waitlist control group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized controlled trial with two intervention groups and a waiting list control group

Study Record Dates

• First Submitted: May 8, 2023
• First Posted: May 17, 2023
• Study Start: August 5, 2022
• Primary Completion: October 21, 2024
• Study Completion: October 21, 2024
• Last Updated: May 11, 2025

Record last verified: 2025-05

Locations

DE (1)