Interoceptive Intervention for Congenital Heart Disease

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Glasgow

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Interoceptive-Based Group Intervention

    Other intervention

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

Treatment groups

32 Participants
are divided into 2 treatment groups
Group A: Cohort 1 (Immediate Intervention)Experimental treatment 1 intervention
Group B: Cohort 2 (Delayed/Waitlist Intervention)No intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline (up to 4 weeks prior to intervention starting) and 8 weeks (during last intervention session)
2

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.

Time frame
At 8 weeks (during last intervention session)

Secondary outcomes

1

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.

Time frame
Baseline (up to 4 weeks prior to intervention starting) and 8 weeks (during last intervention session)
2

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.

Time frame
Baseline (up to 4 weeks prior to intervention starting) and 8 weeks (during last intervention session)
3

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.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Glasgow

Lead sponsor

Golden Jubilee National Hospital

Collaborator

This trial is not recruiting at the moment. You can still explore other options: