InteroceptionNCT07697755
Interoceptive Intervention for Congenital Heart Disease
A study testing Interoceptive-Based Group Intervention in people with Interoception and Congenital Heart Disease, run by University of Glasgow at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Interoception, Congenital Heart Disease
- What is being tested?
- Interoceptive-Based Group Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Katja Weides contact
United Kingdom1 site
Golden Jubilee University National Hospital
Glasgow, G81 4DY
Catherine Sinclair, catherine.sinclair@goldenjubilee.scot.nhs.uk
About this study
Official title: A Randomised Controlled Feasibility Trial Exploring an Interoceptive-Based Intervention in Patients With 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.
Read more
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
- Being tested
- Interoceptive-Based Group Intervention
- Keywords
- Adult Congenital Heart Disease, Interoception, Psychological Intervention, Group Intervention, Pilot Study, Feasibility Randomised Controlled Trial
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interoceptive-Based Group InterventionOther
Also called Group IBI
An 8-week online group intervention aiming to improve interoception.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 (Immediate Intervention) | Experimental | An 8-week online group intervention where participants will learn skills to improve interoception and connect with their body. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At 8 weeks (during last intervention session)
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Baseline (up to 4 weeks prior to intervention starting) and 8 weeks (during last intervention session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study startJul 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for InteroceptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Glasgow
- Sponsor type
- University, hospital or other
- Collaborators
- Golden Jubilee National Hospital
- Responsible party
- Principal investigator, Jason McBurnie, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07697755
- Sponsor's protocol ID
- IRAS ID: 367530
- Other IDs
- 26/SC/0144
- Status last verified
- May 2026
- First submitted
- 23 Jun 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 39711816Kovacs 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.
PubMed 35862009Kovacs 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.
PubMed 38233017Heim 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.
PubMed 37421414Muller-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.
PubMed 15084550Lowe 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.
PubMed 18388841Lowe 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.
PubMed 15183601Moore, D. (2025). Exploring the contribution of psychology in the self-management of pulmonary hypertension (Doctoral dissertation, University of Glasgow).
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.
PubMed 30513087
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Feasibility Trial Exploring an Interoceptive-Based Intervention in Patients With Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT07697755
- Acronym / sponsor ID
- IRAS ID: 367530
- Conditions
- Interoception, Congenital Heart Disease
- Keywords
- Adult Congenital Heart Disease, Interoception, Psychological Intervention, Group Intervention, Pilot Study, Feasibility Randomised Controlled Trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- University of GlasgowUniversity, hospital or other
- Collaborators
- Golden Jubilee National Hospital
- Study start
- Jul 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 13 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 (Immediate Intervention) | Experimental | Other: Interoceptive-Based Group InterventionAn 8-week online group intervention where participants will learn skills to improve interoception and connect with their body. |
| Cohort 2 (Delayed/Waitlist Intervention) | No intervention | –Participants will wait until Cohort 1 (Immediate Intervention) have completed the intervention before commencing themselves |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interoceptive-Based Group InterventionAlso: Group IBIAn 8-week online group intervention aiming to improve interoception. | Other | Cohort 1 (Immediate Intervention) |
Primary outcome
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.
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.
3 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Background: PubMed 39711816Moons 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.
- Background: PubMed 35862009Kovacs 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.
- Background: PubMed 38233017Kovacs 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.
- Background: PubMed 37421414Heim 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.
- Background: PubMed 15084550Muller-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.
- Background: PubMed 18388841Lowe 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.
- Background: PubMed 15183601Lowe 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.
- BackgroundMoore, D. (2025). Exploring the contribution of psychology in the self-management of pulmonary hypertension (Doctoral dissertation, University of Glasgow).
- Background: PubMed 30513087Mehling 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Katja Weides contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interoceptive-Based Group Intervention in people with Interoception and Congenital Heart Disease, run by University of Glasgow at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jason McBurnie (07710885146 ext. +44, 2272649m@student.gla.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07697755, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.