Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

Interoceptive Intervention for Congenital Heart Disease

8 luglio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

32

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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)

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Cohort 1 (Immediate Intervention)
An 8-week online group intervention where participants will learn skills to improve interoception and connect with their body.
An 8-week online group intervention aiming to improve interoception.
Altri nomi:
  • Group IBI
Nessun intervento: Cohort 2 (Delayed/Waitlist Intervention)
Participants will wait until Cohort 1 (Immediate Intervention) have completed the intervention before commencing themselves

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Multidimensional Assessment of Interoceptive Awareness (MAIA-2)
Lasso di tempo: 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
Lasso di tempo: 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)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
The Generalised Anxiety Disorders Scale (GAD-7)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 luglio 2026

Completamento primario (Stimato)

1 dicembre 2026

Completamento dello studio (Stimato)

1 dicembre 2026

Date di iscrizione allo studio

Primo inviato

23 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

8 luglio 2026

Primo Inserito (Effettivo)

13 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

13 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

8 luglio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Cardiopatia congenita

Prove cliniche su Interoceptive-Based Group Intervention

3
Sottoscrivi