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NCT Number: NCT07697755

Interoceptive Intervention for Congenital Heart Disease

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Golden Jubilee University National Hospital

Glasgow, G81 4DY, United Kingdom

Location contact

Catherine Sinclair

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Interoceptive-Based Group Intervention

Other

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

Other names: Group IBI

Primary outcomes

  1. 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)

    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.

  2. Feasibility and Acceptability Questionnaire

    Time frame: 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 outcomes

  1. 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)

    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.

  2. Patient Health Questionnaire 9 (PHQ-9)

    Time frame: 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.

  3. Short Form Health Survey (SF-12)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jason McBurnie

CONTACT

[email protected]

07710885146 ext. +44

Katja Weides

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Glasgow

Other

Collaborators

  • Golden Jubilee National Hospital

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 13, 2026
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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