Efficacy of a Web-Based Emotion Regulation Intervention for Patients With Congenital Heart Disease
NCT ID: NCT05862909
Last Updated: 2025-05-11
Study Results
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Basic Information
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COMPLETED
NA
524 participants
INTERVENTIONAL
2022-08-05
2024-10-21
Brief Summary
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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.
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Detailed Description
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Method: The present three-armed randomized clinical trial evaluates the efficacy of web-based emotion regulation interventions in individuals with CHD. Patients with CHD over 18 years old will be randomly assigned to:
1. A CHD-specific web-based emotion regulation intervention.
2. A general web-based emotion regulation intervention.
3. A waitlist control group with delayed intervention access (8 weeks).
The interventions are conducted via mobile phone or desktop browsers and are based on cognitive behavioral therapy, including everyday emotion regulation exercises and psychoeducation via video material and audio files. Four and eight weeks after baseline, emotion regulation abilities, well-being, depression, anxiety, perceived stress, life satisfaction, and illness identity will be assessed as outcome measures.
Hypotheses: Both interventions are expected to enhance emotion regulation abilities four and eight weeks after baseline compared to the waitlist control group. In addition, the interventions are hypothesized to improve well-being, depressive symptoms, anxiety, perceived stress, life satisfaction, and illness identity. The disease-specific intervention is assumed to be superior to the general emotion regulation intervention as it targets everyday emotional challenges in CHD patients.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Intervention group (IG 1)
CHD-specific web-based emotion regulation intervention
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.
Intervention group (IG 2)
General web-based emotion regulation intervention
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.
Waitlist control group (CG)
8-week waiting period
No interventions assigned to this group
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* permanent internet access during the study period
* diagnosis of a congenital heart disease
* ≥ 18 years of age
Exclusion Criteria
* acute suicidality
18 Years
ALL
No
Sponsors
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Competence Network for Congenital Heart Defects
OTHER_GOV
Heidelberg University
OTHER
Responsible Party
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Luise Pruessner
Principal Investigator
Principal Investigators
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Luise Pruessner
Role: PRINCIPAL_INVESTIGATOR
Department of Psychology, Heidelberg University, Heidelberg (Germany)
Steffen Hartmann
Role: PRINCIPAL_INVESTIGATOR
Department of Psychology, Heidelberg University, Heidelberg (Germany)
Anna-Lena Ehmann
Role: PRINCIPAL_INVESTIGATOR
Department of Psychology, Heidelberg University, Heidelberg (Germany)
Sven Barnow
Role: PRINCIPAL_INVESTIGATOR
Department of Psychology, Heidelberg University, Heidelberg (Germany)
Ulrike Bauer
Role: PRINCIPAL_INVESTIGATOR
National Register for Congenital Heart Defects, Berlin (Germany)
Paul Helm
Role: PRINCIPAL_INVESTIGATOR
National Register for Congenital Heart Defects, Berlin (Germany)
Locations
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Competence Network for Congenital Heart Defects
Berlin, , Germany
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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ER-CHD
Identifier Type: -
Identifier Source: org_study_id
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