Interoceptive Intervention for Congenital Heart Disease

Official title

A Randomised Controlled Feasibility Trial Exploring an Interoceptive-Based Intervention in Patients With Congenital Heart Disease

Overview

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

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

Primary outcome measures

• 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)]
• Feasibility and Acceptability Questionnaire [Time frame: At 8 weeks (during last intervention session)]

Secondary outcome measures (3)

• The Generalised Anxiety Disorders Scale (GAD-7) [Time frame: Baseline (up to 4 weeks prior to intervention starting) and 8 weeks (during last intervention session)]
• Patient Health Questionnaire 9 (PHQ-9) [Time frame: Baseline (up to 4 weeks prior to intervention starting) and 8 weeks (during last intervention session)]
• Short Form Health Survey (SF-12) [Time frame: Baseline (up to 4 weeks prior to intervention starting) and 8 weeks (during last intervention session)]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

United Kingdom · 1 center

• Golden Jubilee University National Hospital — Glasgow

Publications

• 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
• 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 PMID 35862009
• 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 Depress PMID 38233017
• 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
• 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
• 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
• 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
• Moore, D. (2025). Exploring the contribution of psychology in the self-management of pulmonary hypertension (Doctoral dissertation, University of Glasgow).

Identifiers

NCT: NCT07697755 · IRAS ID: 367530 · 26/SC/0144

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗