Interoceptive Intervention for Congenital Heart Disease

NCT07697755 | Not Yet Recruiting

• 2 other identifiers: IRAS ID: 36753026/SC/0144
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Interoception; Congenital Heart Disease

Keywords

Adult Congenital Heart Disease; Interoception; Psychological Intervention; Group Intervention; Pilot Study; Feasibility Randomised Controlled Trial

Outcome Measures

Primary Outcomes (2)

• 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)

Secondary Outcomes (3)

• The Generalised Anxiety Disorders Scale (GAD-7)

  Baseline (up to 4 weeks prior to intervention starting) and 8 weeks (during last intervention session)

• Patient Health Questionnaire 9 (PHQ-9)

  Baseline (up to 4 weeks prior to intervention starting) and 8 weeks (during last intervention session)

• Short Form Health Survey (SF-12)

  Baseline (up to 4 weeks prior to intervention starting) and 8 weeks (during last intervention session)

Study Arms (2)

Cohort 1 (Immediate Intervention)

EXPERIMENTAL

An 8-week online group intervention where participants will learn skills to improve interoception and connect with their body.

Other: Interoceptive-Based Group Intervention

Cohort 2 (Delayed/Waitlist Intervention)

NO INTERVENTION

Participants will wait until Cohort 1 (Immediate Intervention) have completed the intervention before commencing themselves

Interventions

Interoceptive-Based Group Intervention OTHER

An 8-week online group intervention aiming to improve interoception.

Also known as: Group IBI

Cohort 1 (Immediate Intervention)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Glasgow: lead
• Golden Jubilee National Hospital: collaborator

Study Sites (1)

Golden Jubilee University National Hospital

Glasgow, G81 4DY, United Kingdom

Location

Related Publications (9)

• 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.

  PMID: 39711816 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.

  PMID: 35862009 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.

  PMID: 38233017 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.

  PMID: 37421414 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.

  PMID: 15084550 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.

  PMID: 18388841 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.

  PMID: 15183601 BACKGROUND

• Moore, D. (2025). Exploring the contribution of psychology in the self-management of pulmonary hypertension (Doctoral dissertation, University of Glasgow).

  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.

  PMID: 30513087 BACKGROUND

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Jason McBurnie

CONTACT

07710885146; 2272649m@student.gla.ac.uk

Katja Weides

CONTACT

Katja.Weides@glasgow.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Trainee Clinical Psychologist

Study Record Dates

• First Submitted: June 23, 2026
• First Posted: July 13, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 13, 2026

Record last verified: 2026-05

Locations

GB (1)