Clinical trial NCT05862909: Efficacy of a Web-Based Emotion Regulation Intervention for Patients With Congenital Heart Disease
Official title: Efficacy of a Web-Based Emotion Regulation Intervention for Patients With Congenital Heart Disease: A Three-Armed Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congenital Heart Disease
Emotional Regulation
Keywords: Congenital Heart Disease
Emotional Regulation
Internet-Based Interventions
Emotions
Lead sponsor: Heidelberg University
Sponsor class: OTHER
Collaborators: name: Competence Network for Congenital Heart Defects
First posted: 2023-05-17
Enrollment: 524
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial with two intervention groups and a waiting list control group
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in emotion regulation difficulties
timeFrame: 0 weeks, 4 weeks, 8 weeks
Secondary outcomes:
measure: Changes in emotion regulation strategy use
timeFrame: 0 weeks, 4 weeks, 8 weeks
measure: Changes in well-being
timeFrame: 0 weeks, 4 weeks, 8 weeks
measure: Changes in depressive symptoms
timeFrame: 0 weeks, 4 weeks, 8 weeks
measure: Changes in anxiety symptoms
timeFrame: 0 weeks, 4 weeks, 8 weeks
measure: Changes in perceived stress
timeFrame: 0 weeks, 4 weeks, 8 weeks
measure: Changes in life satisfaction The satisfaction with life scale consists of 5 items answered on a 7-point scale.
timeFrame: 0 weeks, 4 weeks, 8 weeks
measure: Changes in illness identity
timeFrame: 0 weeks, 4 weeks, 8 weeks
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Competence Network for Congenital Heart Defects
Study officials:
affiliation: Department of Psychology, Heidelberg University, Heidelberg (Germany)
name: Luise Pruessner
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Psychology, Heidelberg University, Heidelberg (Germany)
name: Steffen Hartmann
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Psychology, Heidelberg University, Heidelberg (Germany)
name: Anna-Lena Ehmann
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Psychology, Heidelberg University, Heidelberg (Germany)
name: Sven Barnow
role: PRINCIPAL_INVESTIGATOR
affiliation: National Register for Congenital Heart Defects, Berlin (Germany)
name: Ulrike Bauer
role: PRINCIPAL_INVESTIGATOR
affiliation: National Register for Congenital Heart Defects, Berlin (Germany)
name: Paul Helm
role: PRINCIPAL_INVESTIGATOR
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