Congenital Heart DiseaseNCT05862909
Efficacy of a Web-Based Emotion Regulation Intervention for Patients With Congenital Heart Disease
A study testing CHD-specific web-based emotion regulation intervention and General web-based emotion regulation intervention in people with Congenital Heart Disease and Emotional Regulation, run by Heidelberg University at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congenital Heart Disease, Emotional Regulation
- What is being tested?
- CHD-specific web-based emotion regulation intervention and General web-based emotion regulation intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 524 participants
- Where
- 1 siteGermany
- Study dates
- 5 Aug 2022to 21 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- sufficient German language skills (C1)
- permanent internet access during the study period
- diagnosis of a congenital heart disease
- ≥ 18 years of age
Who cannot join
- incapacity to provide informed consent
- acute suicidality
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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:
- 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.
- Conditions
- Congenital Heart Disease, Emotional Regulation
- Being tested
- CHD-specific web-based emotion regulation intervention, General web-based emotion regulation intervention
- Keywords
- Congenital Heart Disease, Emotional Regulation, Internet-Based Interventions, Emotions
- Medical subject headings
- Heart Defects, Congenital, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHD-specific web-based emotion regulation interventionOther
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 interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group (IG 1) | Experimental | CHD-specific web-based emotion regulation intervention Receives: Other: CHD-specific web-based emotion regulation intervention |
| Intervention group (IG 2) | Active comparator | General web-based emotion regulation intervention Receives: Other: General web-based emotion regulation intervention |
| Waitlist control group (CG) | No intervention | 8-week waiting period |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0 weeks, 4 weeks, 8 weeks
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 0 weeks, 4 weeks, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2023
- Study start5 Aug 2022
- Primary completion21 Oct 2024
- Study completion21 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial with two intervention groups and a waiting list control group
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 524 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Collaborators
- Competence Network for Congenital Heart Defects
- Responsible party
- Principal investigator, Luise Pruessner, Heidelberg University
- Investigators
- Luise Pruessner, Principal investigator, Department of Psychology, Heidelberg University, Heidelberg (Germany)Steffen Hartmann, Principal investigator, Department of Psychology, Heidelberg University, Heidelberg (Germany)Anna-Lena Ehmann, Principal investigator, Department of Psychology, Heidelberg University, Heidelberg (Germany)Sven Barnow, Principal investigator, Department of Psychology, Heidelberg University, Heidelberg (Germany)Ulrike Bauer, Principal investigator, National Register for Congenital Heart Defects, Berlin (Germany)Paul Helm, Principal investigator, National Register for Congenital Heart Defects, Berlin (Germany)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05862909
- Sponsor's protocol ID
- ER-CHD
- Status last verified
- May 2025
- First submitted
- 8 May 2023
- Last updated
- 11 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 28730850Kroenke 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.
PubMed 11556941Spitzer 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.
PubMed 16717171Topp 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.
PubMed 25831962Oris 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.
PubMed 26989179Klein 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.
PubMed 27216151Ritschel 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.
PubMed 25774638Diener 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.
PubMed 16367493Pruessner L, Hartmann S, Ehmann AL, Barnow S, Bauer UMM, Helm PC. Digital Emotion Regulation Interventions for Patients With Congenital Heart Disease: A Randomized Clinical Trial. JAMA Netw Open. 2025 Oct 1;8(10):e2538813. doi: 10.1001/jamanetworkopen.2025.38813.
PubMed 41134574
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Web-Based Emotion Regulation Intervention for Patients With Congenital Heart Disease: A Three-Armed Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05862909
- Acronym / sponsor ID
- ER-CHD
- Conditions
- Congenital Heart Disease, Emotional Regulation
- Keywords
- Congenital Heart Disease, Emotional Regulation, Internet-Based Interventions, Emotions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 524 participants (actual)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Collaborators
- Competence Network for Congenital Heart Defects
- Study start
- 5 Aug 2022 (actual)
- Primary completion
- 21 Oct 2024 (actual)
- Study completion
- 21 Oct 2024 (actual)
- First posted
- 17 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized controlled trial with two intervention groups and a waiting list control group
| Arm | Type | Receives |
|---|---|---|
| Intervention group (IG 1) | Experimental | Other: CHD-specific web-based emotion regulation interventionCHD-specific web-based emotion regulation intervention |
| Intervention group (IG 2) | Active comparator | Other: General web-based emotion regulation interventionGeneral web-based emotion regulation intervention |
| Waitlist control group (CG) | No intervention | –8-week waiting period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- sufficient German language skills (C1)
- permanent internet access during the study period
- diagnosis of a congenital heart disease
- ≥ 18 years of age
Key exclusion criteria (2 listed)
- incapacity to provide informed consent
- acute suicidality
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CHD-specific web-based emotion regulation interventionCHD-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. | Other | Intervention group (IG 1) |
| General web-based emotion regulation interventionGeneral 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. | Other | Intervention group (IG 2) |
Primary outcome
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.
7 secondary outcomes
Changes in emotion regulation strategy use
Time frame: 0 weeks, 4 weeks, 8 weeks
Changes in well-being
Time frame: 0 weeks, 4 weeks, 8 weeks
Changes in depressive symptoms
Time frame: 0 weeks, 4 weeks, 8 weeks
Changes in anxiety symptoms
Time frame: 0 weeks, 4 weeks, 8 weeks
Changes in perceived stress
Time frame: 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.
Time frame: 0 weeks, 4 weeks, 8 weeks
Changes in illness identity
Time frame: 0 weeks, 4 weeks, 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2025.
- Background: PubMed 28730850Izadpanah 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.
- Background: PubMed 11556941Kroenke 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.
- Background: PubMed 16717171Spitzer 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.
- Background: PubMed 25831962Topp 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.
- Background: PubMed 26989179Oris 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.
- Background: PubMed 27216151Klein 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.
- Background: PubMed 25774638Ritschel 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.
- Background: PubMed 16367493Diener 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.
- Derived from this study: PubMed 41134574Pruessner L, Hartmann S, Ehmann AL, Barnow S, Bauer UMM, Helm PC. Digital Emotion Regulation Interventions for Patients With Congenital Heart Disease: A Randomized Clinical Trial. JAMA Netw Open. 2025 Oct 1;8(10):e2538813. doi: 10.1001/jamanetworkopen.2025.38813.
Related trials for Congenital Heart Disease
RecruitingObservational study
A 10-Minute Cardiovascular Magnetic Resonance Protocol for Cardiac Disease
Coronary Artery Disease, Myocarditis
Active, not recruiting
Learning by Heart: The Effectiveness of an EF Training Program for Pre-schoolers With Critical CHD
Congenital Heart Disease, Executive Dysfunction
Not yet recruiting
UltraTrac for Cardiac Output Monitoring in Congenital Heart Disease
Congenital Heart Disease, Cardiac Output
RecruitingPhase 1/2
Butyric Acid Supplementation for Gut Improvement After Cardiac Surgery in Kids
Congenital Heart Disease (CHD)
Not yet recruiting
Starry-Sky Projection and Maternal Voice for Sleep After Pediatric Cardiac Surgery
Congenital Heart Disease (CHD), Postoperative Sleep
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luise Pruessner principal investigator
Department of Psychology, Heidelberg University, Heidelberg (Germany)
Steffen Hartmann principal investigator
Department of Psychology, Heidelberg University, Heidelberg (Germany)
Anna-Lena Ehmann principal investigator
Department of Psychology, Heidelberg University, Heidelberg (Germany)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CHD-specific web-based emotion regulation intervention and General web-based emotion regulation intervention in people with Congenital Heart Disease and Emotional Regulation, run by Heidelberg University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in emotion regulation difficulties (time frame: 0 weeks, 4 weeks, 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05862909, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2025.