Highlights
– In a nationwide German randomized clinical trial (n=524), a 4‑week tailored digital emotion regulation program reduced emotion regulation difficulties versus usual care (Cohen d = -0.45) at postintervention and maintained gains at follow‑up.
– The tailored program produced moderate improvements across well‑being, life satisfaction, anxiety, depression, stress, and emotion regulation repertoire; a general (non‑tailored) program produced smaller, delayed effects (notable for stress reduction at postintervention and broader benefits by follow‑up).
– Direct comparison favored the tailored format for expanding emotion regulation repertoire; both digital approaches show promise as scalable psychosocial options for adults living with congenital heart disease (CHD).
Background: Unmet psychosocial needs in adults with CHD
Advances in pediatric cardiology and cardiac surgery have increased survival for congenital heart disease (CHD), producing a growing population of adolescents and adults who live long term with residual hemodynamic lesions, reoperations, arrhythmia risk, and lifelong medical surveillance. Alongside medical complexity, psychosocial burden is substantial: adults with CHD report higher rates of anxiety, depression, stress, and reduced health‑related quality of life compared with peers. Impaired emotion regulation — difficulties identifying, accepting, and modulating emotional states — is a transdiagnostic mechanism that links chronic illness to poorer mental health and reduced self‑management.
Rationale for digital emotion regulation interventions
Evidence‑based psychosocial treatments (eg, cognitive behavioral therapy, acceptance‑based approaches) improve outcomes in many chronic illnesses but are often inaccessible because of geographic, economic, and provider‑capacity constraints. Digital interventions offer scalable, low‑threshold delivery and can be tailored to condition‑specific needs. Emotion regulation training delivered via brief, structured daily exercises has theoretical and empirical grounding to reduce distress and improve adaptive coping; however, condition‑specific tailoring (eg, addressing illness identity, management stressors) may enhance relevance and uptake for people with CHD.
Study design
The randomized clinical trial by Pruessner et al. (JAMA Network Open, 2025) evaluated two 4‑week digital emotion regulation programs (tailored vs general) versus usual CHD care. Key design features:
- Population: Adults (≥18 years) with congenital heart disease recruited nationwide in Germany between August 5, 2022 and October 21, 2024.
- Randomization: 3‑arm, parallel group design; 524 participants randomized (mean age 35.2 years; 69.5% women).
- Interventions: Daily digital exercises delivered over 4 weeks. One program was tailored to the lived experience of people with CHD (eg, modules addressing illness identity, cardiac‑specific stressors); the other delivered general emotion regulation exercises without CHD‑specific tailoring.
- Comparator: Usual CHD care (control).
- Outcomes: Primary outcome was change in emotion regulation difficulties. Secondary outcomes included emotion regulation repertoire (range of strategies participants can deploy), well‑being, life satisfaction, anxiety, depression, stress, and illness identity. Analyses followed intention‑to‑treat principles.
Key findings
The trial enrolled 524 participants from 1043 screened. Main results at postintervention and follow‑up include:
Primary outcome — emotion regulation difficulties
– Tailored program vs usual care at postintervention: moderate reduction in emotion regulation difficulties (Cohen d = -0.45; 95% CI, -0.72 to -0.18; P = .001).
– General program vs usual care at postintervention: no significant effect on the primary outcome.
– At follow‑up, the tailored program maintained primary‑outcome gains; the general program demonstrated delayed improvements leading to significant reductions in emotion regulation difficulties by follow‑up.
Secondary outcomes — repertoire, well‑being, life satisfaction, symptoms
– Emotion regulation repertoire: tailored program improved repertoire compared with usual care (Cohen d = 0.49; 95% CI, 0.18–0.78; P < .001). Direct head‑to‑head favored the tailored program over the general program for repertoire both at postintervention (Cohen d = 0.26; 95% CI, 0.07–0.45; P = .007) and follow‑up (Cohen d = 0.33; 95% CI, 0.11–0.55; P = .004).
– Well‑being and life satisfaction: tailored program improved well‑being (d = 0.39) and life satisfaction (d = 0.37) at postintervention versus usual care.
– Anxiety, depression, and stress: the tailored program reduced anxiety (d = -0.38), depression (d = -0.40), and stress (d = -0.54) at postintervention versus usual care. The general program reduced stress at postintervention only (d = -0.32); by follow‑up the general program had broader benefits on anxiety, depression, and stress.
Comparative interpretation
Effect sizes for the tailored program were generally in the small‑to‑moderate range (Cohen d ≈ 0.3–0.5) across several clinically relevant domains. The general program produced smaller early effects, with some catch‑up by follow‑up. Direct comparison suggests tailoring primarily enhances the breadth of strategies participants acquire (the repertoire), which plausibly mediates downstream improvements in mood and well‑being.
Safety and adherence
The published summary did not highlight safety concerns or major adverse events. Digital, low‑intensity emotion regulation programs typically carry low physical risk; however, the potential for transient increases in distress when confronting difficult emotions warrants monitoring and accessible escalation pathways in clinical deployment.
Expert commentary and mechanistic insight
These findings align with theoretical models that posit emotion regulation flexibility and a larger strategy repertoire enable better adaptation to illness‑related stressors. Tailored interventions likely increase relevance, engagement, and uptake by directly addressing illness identity, uncertainty, and condition‑specific triggers that people with CHD experience (eg, concerns about exercise limitations, reproductive decisions, or long‑term prognosis). The trial demonstrates that brief, digital emotion regulation training can produce measurable changes in both process outcomes (repertoire, regulation difficulties) and clinical outcomes (symptoms, well‑being).
From a clinical standpoint, the moderate effect sizes are meaningful at a population level when delivered at scale: even small to moderate improvements in anxiety, depression, and stress can translate into reduced healthcare utilization, improved adherence, and better quality of life among adults with chronic cardiac conditions.
Limitations and generalizability
Key limitations to consider when interpreting the results:
- Population and setting: The trial was conducted in Germany with a predominantly female sample (≈70% women) and mean age 35 years. Generalizability to older adults with CHD, pediatric populations transitioning to adult care, or different healthcare systems requires caution.
- Intervention duration and intensity: The programs lasted 4 weeks with daily exercises; longer interventions or booster sessions might yield larger or more durable effects.
- Reporting of adherence, usage patterns, and adverse events: The summary provided here did not detail attrition, engagement metrics, or safety signals; these data are essential for planning clinical implementation.
- Comparative active control: Usual care is a pragmatic comparator but does not control for non‑specific effects such as attention; the general program partially addresses that but was less effective early on, complicating attribution of mechanisms.
Clinical and health system implications
For clinicians and program planners caring for adults with CHD, the trial provides the following actionable insights:
- Digital emotion regulation interventions can be an evidence‑based adjunct to usual cardiac care, especially where access to specialty mental health services is limited.
- Tailoring content to the lived experience of people with CHD enhances acquisition of regulation strategies and accelerates symptom improvement, supporting investment in condition‑specific adaptation of digital tools.
- Implementation should include routine outcome monitoring, clear escalation pathways for participants with severe symptoms, and strategies to maximize engagement among diverse patient subgroups.
Research priorities
Future studies should examine: longer‑term clinical outcomes (eg, health‑related quality of life, healthcare utilization), mechanisms of change (does increased repertoire mediate symptom improvement?), effectiveness in broader and older CHD cohorts, cost‑effectiveness, and optimal implementation models (integrated into cardiology clinics vs community delivery). Comparative trials against therapist‑delivered interventions would clarify relative benefits and roles across stepped care models.
Conclusions
This randomized clinical trial demonstrates that a brief, tailored digital emotion regulation program produced moderate, clinically meaningful improvements in emotion regulation, mood symptoms, and well‑being among adults with congenital heart disease, with effects maintained at follow‑up. A general, non‑tailored program showed smaller, delayed effects. These results support the potential of tailored digital psychosocial interventions to expand access to mental health care for people living with chronic cardiac conditions and highlight the value of condition‑specific content to maximize clinical impact.
Funding and trial registration
The trial is registered at ClinicalTrials.gov (Identifier: NCT05862909). Funding details were not provided in the summary used for this article; readers should consult the full publication for funding and conflicts of interest statements.
References
1. Pruessner 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 . PMID: 41134574 ; PMCID: PMC12552930 .
2. Warnes CA, Williams RG, Bashore TM, et al. ACC/AHA 2008 Guidelines for the Management of Adults With Congenital Heart Disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2008;52(23):e143–263. (Guideline overview for adult congenital heart disease care.)
3. World Health Organization. Mental health action plan 2013–2020. Geneva: WHO; 2013. (Context on population mental health priorities and the role of scalable interventions.)