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

Study Overview
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Brief Summary
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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.

Detailed Description
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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: A CHD-specific web-based emotion regulation intervention. A general web-based emotion regulation intervention. 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.

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

Conditions
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Congenital Heart Disease, Emotional Regulation

Intervention / Treatment
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* Other: CHD-specific web-based emotion regulation intervention
* Other: General web-based emotion regulation intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial with two intervention groups and a waiting list control group
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Congenital Heart Disease, Emotional Regulation, Internet-Based Interventions, Emotions