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

Efficacy of a Web-Based Emotion Regulation Intervention for Patients With Congenital Heart Disease: A Three-Armed Randomized Clinical Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Congenital Heart Disease; Emotional Regulation
• Intervention / Treatment: Other: CHD-specific web-based emotion regulation intervention; Other: General web-based emotion regulation intervention

Detailed Description

Background: Congenital heart disease (CHD) is associated with significant everyday stressors and impairments in functioning that can induce various negative emotions such as fear, anger, or sadness. When faced with negative emotions caused by the chronic illness, emotion regulation abilities might be central for determining whether individuals with CHD develop symptoms of psychopathology or successfully adjust to the illness-related regulatory demands. Therefore, training emotion regulation abilities offers a promising approach to enhancing psychological well-being in individuals affected by CHD. As patients with CHD face specific challenges, disease-specific emotion regulation interventions may be beneficial in promoting successful adjustment to the condition. Nevertheless, no studies have been conducted to test the effectiveness of emotion regulation interventions for individuals with CHD.

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.

• Study Type: Interventional
• Enrollment (Estimated): 520
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Luise Pruessner; Phone Number: +496221547282; Email: luise.pruessner@psychologie.uni-heidelberg.de
• Study Contact Backup: Name: Steffen Hartmann; Phone Number: +496221547295; Email: steffen.hartmann@psychologie.uni-heidelberg.de

Study Locations

• Germany
  • Berlin, Germany, 13353
    • Recruiting
    • Competence Network for Congenital Heart Defects
    • Contact: Paul Helm; Phone Number: +493045937289; Email: helm@kompetenznetz-ahf.de
    • Contact: Ulrike Bauer; Phone Number: +493045937277; Email: ubauer@kompetenznetz-ahf.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion criteria:

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

Exclusion criteria:

• incapacity to provide informed consent
• acute suicidality

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group (IG 1); CHD-specific web-based emotion regulation intervention	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.
Active Comparator: Intervention group (IG 2); General web-based emotion regulation 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.
No Intervention: Waitlist control group (CG); 8-week waiting period

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in emotion regulation strategy use	The Heidelberg Form for Emotion Regulation Strategies (HFERST; Izadpanah et al., 2019) consists of 28 items answered on a 5-point scale. For each of the eight emotion regulation strategies (rumination, reappraisal, acceptance, problem solving, suppression of emotional expression, suppression of emotional experience, avoidance, social support), a score ranging from 1 to 5 can be calculated. Higher values indicate a more frequent emotion regulation strategy use.	0 weeks, 4 weeks, 8 weeks
Changes in well-being	The World Health Organization Well-Being Index (WHO-5; Topp et al., 2015) consists of 5 items answered on a 6-point scale. The overall score ranges from 0 to 100. Higher values indicate a higher level of well-being.	0 weeks, 4 weeks, 8 weeks
Changes in depressive symptoms	The Patient Health Questionnaire (PHQ-9; Kroenke et al., 2001) consists of 9 items answered on a 4-point scale. The overall score ranges from 0 to 27. Higher values indicate a higher level of depressive symptomology.	0 weeks, 4 weeks, 8 weeks
Changes in anxiety symptoms	The General Anxiety Disorder Scale (GAD-7; Spitzer et al., 2006) consists of 7 items answered on a 4-point scale. The overall score ranges from 0 to 21. Higher values indicate a higher level of anxiety symptoms.	0 weeks, 4 weeks, 8 weeks
Changes in perceived stress	The Perceived Stress Scale (PSS-4; Klein et al., 2014) consists of 4 items answered on a 5-point scale. The overall score ranges from 0 to 16. Higher values indicate a higher level of perceived stress.	0 weeks, 4 weeks, 8 weeks
Changes in life satisfaction The satisfaction with life scale consists of 5 items answered on a 7-point scale.	The satisfaction with life scale (SWLS; Diener et al., 1985) consists of 5 items answered on a 7-point scale. The overall score ranges from 5 to 35. Higher values indicate a higher life satisfaction.	0 weeks, 4 weeks, 8 weeks
Changes in illness identity	The Illness Identity Questionnaire (IIQ; Oris et al., 2016) consists of 25 items answered on a 5-point scale. The overall score ranges from 25 to 125. Higher values indicate a higher level of perceived stress.	0 weeks, 4 weeks, 8 weeks

Collaborators and Investigators

• Sponsor: Heidelberg University
• Collaborators: Competence Network for Congenital Heart Defects
• Investigators: Principal Investigator: 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)

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2022
• Primary Completion (Estimated): August 1, 2023
• Study Completion (Estimated): September 1, 2023

Study Registration Dates

• First Submitted: May 8, 2023
• First Submitted That Met QC Criteria: May 8, 2023
• First Posted (Actual): May 17, 2023

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 17, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Congenital Heart Disease; Emotions; Emotional Regulation; Internet-Based Interventions
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Diseases; Heart Defects, Congenital
• Other Study ID Numbers: ER-CHD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No