Congenital Heart Disease, Interoception
Conditions
Keywords
Adult Congenital Heart Disease, Interoception, Psychological Intervention, Group Intervention, Pilot Study, Feasibility Randomised Controlled Trial
Brief summary
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.
Interventions
OTHERInteroceptive-Based Group Intervention
An 8-week online group intervention aiming to improve interoception.
Sponsors
University of Glasgow
Golden Jubilee National Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Multidimensional Assessment of Interoceptive Awareness (MAIA-2) | Baseline (up to 4 weeks prior to intervention starting) and 8 weeks (during last intervention session) | The MAIA-2 is a 32-item self-report scale measuring eight concepts related to interoception: (1) attention regulation, (2) emotional awareness, (3) noticing, (4) self-regulation, (5) not-worrying, (6) not-distracting, (7) body listening and (8) trusting. Items are answered on a six-point Likert scale ranging from 0 = Never to 5 = Always. Each subscale is interpreted independently to reflect different aspects of interoceptive awareness, including in populations with long-term health conditions. |
| Feasibility and Acceptability Questionnaire | At 8 weeks (during last intervention session) | This questionnaire will assess accessibility, delivery, group format/content, perceived usefulness of exercises and potential impact on anxiety, depression, health-related quality of life or interoception, using a five-point Likert scale (from 1= strongly disagree to 5 = strongly agree). Participants will indicate if they would recommend the intervention and provide qualitative feedback. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Generalised Anxiety Disorders Scale (GAD-7) | Baseline (up to 4 weeks prior to intervention starting) and 8 weeks (during last intervention session) | The GAD-7 is a 7-item self-report scale assessing the frequency and presence of anxiety symptoms over the past two weeks. Items are rated on a four-point Likert scale, ranging from 0 = Not at all to 3 = Nearly every day. Total scores range from 0 to 21, with higher scores indicating more severe anxiety symptoms. It is widely validated in primary care and chronic health settings. |
| Patient Health Questionnaire 9 (PHQ-9) | Baseline (up to 4 weeks prior to intervention starting) and 8 weeks (during last intervention session) | The PHQ-9 is a 9-item self-report scale assessing the frequency and presence of depressive symptoms over the past two weeks. Items are rated on a four-point Likert scale, ranging from 0 = Not at all to 3 = Nearly every day. Total scores range from 0 to 27, with higher scores indicating more severe depressive symptoms. It is widely validated in primary care and chronic health settings. |
| Short Form Health Survey (SF-12) | Baseline (up to 4 weeks prior to intervention starting) and 8 weeks (during last intervention session) | The SF-12 is a 12-item HRQoL self-report scale producing Physical and Mental Component Summary scores from eight domains: (1) physical functioning, (2) physical role limitations, (3) emotional role limitations, (4) bodily pain, (5) general health, (6) vitality, (7) social functioning and (8) mental health. Scores range from 0 to 100; higher total scores indicate better health. The SF-12 has been validated in cardiac populations as an alternative to its longer 36-item version. |
Countries
United Kingdom
Contacts
CONTACTJason McBurnie
CONTACTKatja Weides
Outcome results
None listed