- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07697755
Interoceptive Intervention for Congenital Heart Disease
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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Jason McBurnie
- Telefonnummer: +44 07710885146
- E-Mail: 2272649m@student.gla.ac.uk
Studieren Sie die Kontaktsicherung
- Name: Katja Weides
- E-Mail: Katja.Weides@glasgow.ac.uk
Studienorte
-
-
-
Glasgow, Vereinigtes Königreich, G81 4DY
- Golden Jubilee University National Hospital
-
Kontakt:
- Catherine Sinclair
- E-Mail: catherine.sinclair@goldenjubilee.scot.nhs.uk
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
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)
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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.
Andere Namen:
|
|
Kein Eingriff: Cohort 2 (Delayed/Waitlist Intervention)
Participants will wait until Cohort 1 (Immediate Intervention) have completed the intervention before commencing themselves
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Multidimensional Assessment of Interoceptive Awareness (MAIA-2)
Zeitfenster: 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
Zeitfenster: 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)
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
The Generalised Anxiety Disorders Scale (GAD-7)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- 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.
- Lowe 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.
- Lowe 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.
- Muller-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.
- Heim 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.
- 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.
- Kovacs 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.
- Kovacs 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.
- Moore, D. (2025). Exploring the contribution of psychology in the self-management of pulmonary hypertension (Doctoral dissertation, University of Glasgow).
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- IRAS ID: 367530
- 26/SC/0144 (Andere Kennung: Health Research Authority (HRA))
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur Angeborenen Herzfehler
-
Region SkaneAnmeldung auf EinladungHerzinsuffizienz New York Heart Association (NYHA) Klasse II | Herzinsuffizienz New York Heart Association (NYHA) Klasse IIISchweden
-
Medical University of BialystokMedical University of Lodz; Poznan University of Medical Sciences; Nicolaus Copernicus... und andere MitarbeiterBeendetHerzinsuffizienz, systolisch | Herzinsuffizienz mit reduzierter Ejektionsfraktion | Herzinsuffizienz New York Heart Association Klasse IV | Herzinsuffizienz New York Heart Association Klasse IIIPolen
-
V-Wave LtdJohnson & JohnsonNoch keine RekrutierungHerzinsuffizienz kongestiv | Herzinsuffizienz und reduzierte Ejektionsfraktion | Herzinsuffizienz New York Heart Association Klasse III | Heart Failure Chronic
-
University of WashingtonAmerican Heart AssociationAbgeschlossenHerzinsuffizienz, kongestive | Mitochondriale Veränderung | Herzinsuffizienz New York Heart Association Klasse IVVereinigte Staaten
-
Abbott Medical DevicesThoratec CorporationAbgeschlossenDriveline Heart-assisted Device Related InfectionVereinigte Staaten
-
China National Center for Cardiovascular DiseasesChinese Academy of Medical Sciences, Fuwai HospitalAktiv, nicht rekrutierendLungenentzündung | Sepsis | Infektion | Driveline Heart-assisted Device Related InfectionChina
-
Portuguese Association of Interventional CardiologyMedtronicRekrutierungSchwere symptomatische Aortenstenose (definiert als New York Heart Association (NYHA) Klasse ≥ II)Portugal
-
University Hospital, GasthuisbergUnbekanntTransient Left Ventricular Ballooning SyndromeBelgien
-
NYU Langone HealthRekrutierungTako-Tsubo-Kardiomyopathie | Takotsubo-Kardiomyopathie | Broken-Heart-SyndromVereinigte Staaten
-
Medical University of South CarolinaAmerican Heart AssociationAbgeschlossenSingle Ventricle Heart Disease nach Fontan-OperationVereinigte Staaten
Klinische Studien zur Interoceptive-Based Group Intervention
-
Stanford UniversityBeendetBipolare Störung, NOSVereinigte Staaten
-
Eskisehir Osmangazi UniversityAbgeschlossen
-
Amasya UniversityAbgeschlossenAngst | Schwangerschaft bezogenTruthahn
-
Amasya UniversityAbgeschlossenBetonen | Schwangerschaft, hohes RisikoTruthahn
-
University of PaviaUniversità degli Studi di BresciaAbgeschlossenGeistiges WohlbefindenItalien
-
Hacettepe UniversityAbgeschlossenChronische Lebererkrankung und ZirrhoseTruthahn
-
Samsung Medical CenterNoch keine RekrutierungEltern | Entwicklungsverzögerung | Frühgeboren | Frühintervention | Extreme Frühgeburtlichkeit | Heimübung | Motorisches Ergebnis
-
The University of Hong KongRekrutierungSchwer erreichbare ältere MenschenHongkong
-
Amasya UniversityAbgeschlossenAngst | Schwangerschaft bezogenTruthahn