Interoceptive Intervention for Congenital Heart Disease

Sponsor
University of Glasgow
Study ID
NCT07697755
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Congenital Heart Disease
  • Interoception

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Interoceptive-Based Group Intervention — OTHER
    An 8-week online group intervention aiming to improve interoception.

Study Details

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.

Key Dates

First listed
Jul 13, 2026
Start date
Jul 31, 2026
Status verified
May 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
32 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Cohort 1 (Immediate Intervention)
    An 8-week online group intervention where participants will learn skills to improve interoception and connect with their body.
  • No Intervention: Cohort 2 (Delayed/Waitlist Intervention)
    Participants will wait until Cohort 1 (Immediate Intervention) have completed the intervention before commencing themselves

Primary Outcome Measure

Multidimensional Assessment of Interoceptive Awareness (MAIA-2) [ Time Frame: Baseline (up to 4 weeks prior to intervention starting) and 8 weeks (during last intervention session) ]

Central Contacts

Related Studies