Efficacy of a Web-Based Emotion Regulation Intervention for Patients With Congenital Heart Disease
- Conditions
- Congenital Heart DiseaseEmotional Regulation
- Interventions
- Other: CHD-specific web-based emotion regulation interventionOther: General web-based emotion regulation intervention
- Registration Number
- NCT05862909
- Lead Sponsor
- Heidelberg University
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 524
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention group (IG 1) CHD-specific web-based emotion regulation intervention CHD-specific web-based emotion regulation intervention Intervention group (IG 2) General web-based emotion regulation intervention General web-based emotion regulation intervention
- Primary Outcome Measures
Name Time Method Changes in emotion regulation difficulties 0 weeks, 4 weeks, 8 weeks 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.
- Secondary Outcome Measures
Name Time Method Changes in well-being 0 weeks, 4 weeks, 8 weeks 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.
Changes in emotion regulation strategy use 0 weeks, 4 weeks, 8 weeks 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.
Changes in life satisfaction The satisfaction with life scale consists of 5 items answered on a 7-point scale. 0 weeks, 4 weeks, 8 weeks 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.
Changes in anxiety symptoms 0 weeks, 4 weeks, 8 weeks 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.
Changes in perceived stress 0 weeks, 4 weeks, 8 weeks 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.
Changes in illness identity 0 weeks, 4 weeks, 8 weeks 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.
Changes in depressive symptoms 0 weeks, 4 weeks, 8 weeks 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.
Trial Locations
- Locations (1)
Competence Network for Congenital Heart Defects
🇩🇪Berlin, Germany