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Completed

NCT Number: NCT05862909

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

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.

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Key information

Conditions

Congenital Heart Disease Behavior Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Emotional Regulation Heart Defects, Congenital Heart Diseases Self-Control Social Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Competence Network for Congenital Heart Defects

Berlin, 13353, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Changes in emotion regulation difficulties

    Time frame: 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 outcomes

  1. Changes in emotion regulation strategy use

    Time frame: 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.

  2. Changes in well-being

    Time frame: 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.

  3. Changes in depressive symptoms

    Time frame: 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.

  4. Changes in anxiety symptoms

    Time frame: 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.

  5. Changes in perceived stress

    Time frame: 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.

  6. Changes in life satisfaction The satisfaction with life scale consists of 5 items answered on a 7-point scale.

    Time frame: 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.

  7. Changes in illness identity

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Heidelberg University

Other

Collaborators

  • Competence Network for Congenital Heart Defects

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
May 17, 2023
Registry last updated
May 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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