A Randomised Controlled Feasibility Trial Exploring an Interoceptive-Based Intervention in Patients With Congenital Heart Disease
| Registry | NCT07697755 |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, supportive care |
| Enrollment | 32 (Estimated) |
| Sponsor | University of Glasgow (Other); collaborators: Golden Jubilee National Hospital |
| Conditions | Interoception, Congenital Heart Disease |
| Interventions | Interoceptive-Based Group Intervention (Other) |
| Dates | start 2026-07-01 (estimated), primary completion 2026-12-01 (estimated), completion 2026-12-01 (estimated), first posted 2026-07-13, last updated 2026-07-13 |
| Locations | 1 site in United Kingdom |
Related Papers Related Patents Related Grants Related Experts
All trials for Interoception All trials for Congenital Heart Disease All trials of Interoceptive-Based Group Intervention
Adults living with congenital heart disease (CHD) commonly experience physical symptoms alongside emotional and social challenges, which can affect wellbeing and health-related quality of life. Access to psychological services varies, and evidence to guide the development and delivery of psychological interventions for this population is still emerging.
Interoceptive-based approaches focus on increasing awareness of and responding adaptively to internal bodily sensations, such as breathing, heart rate and fatigue. These approaches have shown benefits in other long-term health conditions but have not yet been studied in adults with CHD. This study will evaluate the feasibility, acceptability, and preliminary effects of a newly adapted online, skills-based group programme for adults with CHD.
Thirty-two participants will be recruited through the Scottish Adult Congenital Cardiac Service and randomly allocated to one of two cohorts: Cohort 1 (Immediate Intervention) and Cohort 2 (Delayed/Waitlist Intervention). The group programme will consist of eight online sessions delivered by a Principal Clinical Psychologist and a Trainee Clinical Psychologist. Weekly sessions will explore the relationship between interoception and key areas relevant to living with CHD, including emotions, behaviours, and physical symptoms. Group discussions and exercises will focus on increasing awareness and understanding of internal bodily sensations, developing strategies for responding to interoceptive cues and using bodily information to guide behaviours and everyday activities.
Participants will complete online questionnaires before and after the intervention assessing interoception, anxiety, depression and health-related quality of life. Participants will also provide feedback regarding the acceptability and perceived usefulness of the programme. Participation is voluntary, and participants may withdraw at any time without affecting their clinical care. Appropriate emotional support will be available should participants experience distress related to the group materials or discussions.
Findings from this feasibility randomised controlled trial will inform further refinement of the group programme, assess the acceptability and feasibility of study procedures, provide estimates of recruitment, retention and outcome variability, and support the design and sample size calculation of a future definitive trial. The findings may also contribute to the enhancement of psychological support for adults with CHD and be disseminated through scientific publications and conference presentations.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Cohort 1 (Immediate Intervention) | Experimental | Other: Interoceptive-Based Group Intervention | An 8-week online group intervention where participants will learn skills to improve interoception and connect with their body. |
| Cohort 2 (Delayed/Waitlist Intervention) | No intervention | Participants will wait until Cohort 1 (Immediate Intervention) have completed the intervention before commencing themselves |
Sex: All, ages: 18 Years to any
Inclusion Criteria: * Participants must be aged 18 years or older * Under the care of the Scottish Adult Congenital Cardiac Service (SACCS) at the Golden Jubilee University National Hospital (GJUNH) * Be able to understand and communicate in English * Provide informed consent * Access and use a device compatible with Microsoft Teams * Be able to commit to the duration of the group programme Exclusion Criteria: * Individuals with current suicidal ideation * Individuals with comorbid alcohol or substance use disorders * Individuals with a diagnosed learning disability * Individuals with a severe and enduring mental health condition (e.g., personality disorder or psychosis) * Individuals with hearing, visual and cognitive difficulties preventing safe online group participation * Individuals who are currently on a surgical or transplant waiting list * Individuals who are receiving intensive psychological treatment (e.g., trauma processing or crisis support)
| Facility | City | Country | Status |
|---|---|---|---|
| Golden Jubilee University National Hospital | Glasgow | United Kingdom |