Interoceptive Intervention for Congenital Heart Disease

July 8, 2026 updated by: Jason McBurnie, University of Glasgow

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.

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1 (Immediate Intervention)
An 8-week online group intervention where participants will learn skills to improve interoception and connect with their body.
Other: Interoceptive-Based Group Intervention
An 8-week online group intervention aiming to improve interoception.
Other Names:
  • Group IBI
No Intervention: Cohort 2 (Delayed/Waitlist Intervention)
Participants will wait until Cohort 1 (Immediate Intervention) have completed the intervention before commencing themselves

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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)
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)
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.
Baseline (up to 4 weeks prior to intervention starting) and 8 weeks (during last intervention session)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Glasgow

Collaborators

Golden Jubilee National Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

June 23, 2026

First Submitted That Met QC Criteria

July 8, 2026

First Posted (Actual)

July 13, 2026

Study Record Updates

Last Update Posted (Actual)

July 13, 2026

Last Update Submitted That Met QC Criteria

July 8, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRAS ID: 367530
  • 26/SC/0144 (Other Identifier: Health Research Authority (HRA))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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