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| ID | Type | Description | Link |
|---|---|---|---|
| 26/SC/0144 | Other Identifier | Health Research Authority (HRA) |
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| Name | Class |
|---|---|
| Golden Jubilee National Hospital | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 (Immediate Intervention) | Experimental | An 8-week online group intervention where participants will learn skills to improve interoception and connect with their body. |
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| Cohort 2 (Delayed/Waitlist Intervention) | No Intervention | Participants will wait until Cohort 1 (Immediate Intervention) have completed the intervention before commencing themselves |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interoceptive-Based Group Intervention | Other | An 8-week online group intervention aiming to improve interoception. |
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| Measure | Description | Time Frame |
|---|---|---|
| Multidimensional Assessment of Interoceptive Awareness (MAIA-2) | 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. | Baseline (up to 4 weeks prior to intervention starting) and 8 weeks (during last intervention session) |
| Feasibility and Acceptability Questionnaire | 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. | At 8 weeks (during last intervention session) |
| Measure | Description | Time Frame |
|---|---|---|
| The Generalised Anxiety Disorders Scale (GAD-7) | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jason McBurnie | Contact | 07710885146 | +44 | 2272649m@student.gla.ac.uk |
| Katja Weides | Contact | Katja.Weides@glasgow.ac.uk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Golden Jubilee University National Hospital | Glasgow | G81 4DY | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39711816 | Background | Moons P, Van Bulck L, Daelman B, Luyckx K. Mental health in adult congenital heart disease. Int J Cardiol Congenit Heart Dis. 2023 Apr 1;12:100455. doi: 10.1016/j.ijcchd.2023.100455. eCollection 2023 Jun. | |
| 35862009 | Background | Kovacs AH, Brouillette J, Ibeziako P, Jackson JL, Kasparian NA, Kim YY, Livecchi T, Sillman C, Kochilas LK; American Heart Association Council on Lifelong Congenital Heart Disease and Heart Health in the Young; and Stroke Council. Psychological Outcomes and Interventions for Individuals With Congenital Heart Disease: A Scientific Statement From the American Heart Association. Circ Cardiovasc Qual Outcomes. 2022 Aug;15(8):e000110. doi: 10.1161/HCQ.0000000000000110. Epub 2022 Jul 14. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 25, 2026 | Jul 8, 2026 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 19, 2026 | Jun 23, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
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| Baseline (up to 4 weeks prior to intervention starting) and 8 weeks (during last intervention session) |
| Patient Health Questionnaire 9 (PHQ-9) | 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. | Baseline (up to 4 weeks prior to intervention starting) and 8 weeks (during last intervention session) |
| Short Form Health Survey (SF-12) | 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. | Baseline (up to 4 weeks prior to intervention starting) and 8 weeks (during last intervention session) |
| 38233017 | Background | Kovacs AH, Luyckx K, Thomet C, Budts W, Enomoto J, Sluman MA, Lu CW, Jackson JL, Khairy P, Cook SC, Chidambarathanu S, Alday L, Estensen ME, Dellborg M, Berghammer M, Johansson B, Mackie AS, Menahem S, Caruana M, Veldtman G, Soufi A, Jameson SM, Callus E, Kutty S, Oechslin E, Van Bulck L, Moons P; APPROACH-IS Consortium, International Society for Adult Congenital Heart Disease. Anxiety and Depression in Adults With Congenital Heart Disease. J Am Coll Cardiol. 2024 Jan 23;83(3):430-441. doi: 10.1016/j.jacc.2023.10.043. |
| 37421414 | Background | Heim N, Bobou M, Tanzer M, Jenkinson PM, Steinert C, Fotopoulou A. Psychological interventions for interoception in mental health disorders: A systematic review of randomized-controlled trials. Psychiatry Clin Neurosci. 2023 Oct;77(10):530-540. doi: 10.1111/pcn.13576. Epub 2023 Aug 9. |
| 15084550 | Background | Muller-Nordhorn J, Roll S, Willich SN. Comparison of the short form (SF)-12 health status instrument with the SF-36 in patients with coronary heart disease. Heart. 2004 May;90(5):523-7. doi: 10.1136/hrt.2003.013995. |
| 18388841 | Background | Lowe B, Decker O, Muller S, Brahler E, Schellberg D, Herzog W, Herzberg PY. Validation and standardization of the Generalized Anxiety Disorder Screener (GAD-7) in the general population. Med Care. 2008 Mar;46(3):266-74. doi: 10.1097/MLR.0b013e318160d093. |
| 15183601 | Background | Lowe B, Kroenke K, Herzog W, Grafe K. Measuring depression outcome with a brief self-report instrument: sensitivity to change of the Patient Health Questionnaire (PHQ-9). J Affect Disord. 2004 Jul;81(1):61-6. doi: 10.1016/S0165-0327(03)00198-8. |
| Background | Moore, D. (2025). Exploring the contribution of psychology in the self-management of pulmonary hypertension (Doctoral dissertation, University of Glasgow). |
| 30513087 | Background | Mehling WE, Acree M, Stewart A, Silas J, Jones A. The Multidimensional Assessment of Interoceptive Awareness, Version 2 (MAIA-2). PLoS One. 2018 Dec 4;13(12):e0208034. doi: 10.1371/journal.pone.0208034. eCollection 2018. |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |