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Raising awareness of the bodily responses to stress (interoceptive awareness) with a psychological intervention

Interoceptive iNsight and Metacognitive Efficacy beliefs (InMe): RCT protocol for a biofeedback-assisted psychological intervention for interoceptive awareness.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN16762367
Enrollment
120
Registered
2022-07-06
Start date
2022-06-29
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy individuals with low levels of interoception awareness Other

Interventions

We aim to recruit 120 people experiencing low interoception awareness, as measured by the Bodily Awareness Questionnaire (BAQ), who will be individually randomised to receive InMe intervention ("InMe

Sponsors

University College London
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 30 years old 2. Low levels of interoception awareness with a score on the Bodily Awareness Questionnaire (BAQ) <25 percentile (Depending on recruitment rate we will need to consider less restrictive criterion of < 30/40 percentile)

Exclusion criteria

Exclusion criteria: 1. Existing substance dependency, moderate to severe cognitive impairment and severe mental health conditions (e.g., psychosis) 2. Existing severe neurological condition (e.g., epilepsy) 3. Existing diagnosis of heart-disease 4. Current use of neurological, cardiac (e.g., medications that influence blood pressure/cardiovascular functioning) or psychiatric medication (via self-report) 5. Body mass index (BMI) = 30, where BMI = kg/m2 6. Low vision/hearing that cannot be corrected 7. Unable to fluently understand English speakers 8. Pregnancy

Design outcomes

Primary

MeasureTime frame
Adaptive interoception measured using the 25 items from the Multidimensional Assessment of Interoceptive Awareness (MAIA) questionnaire at baseline, up to 5 days before the first visit/intervention (T0), at the end of the day of the second visit/intervention, scheduled 5 to 9 days following the first visit (T1b) and at follow-up 7 to 9 weeks after T0 (T2)

Secondary

MeasureTime frame
1. Measures of Interoception: 1.1. Interoceptive self-efficacy beliefs updating measured using computational methods (see https://osf.io/x4ysv) at baseline (T0) 1.2. Interoception accuracy measured by the Heart Rate Discrimination (HRD) task at T0, at the end of the day of the second visit/intervention, scheduled 5 to 9 days following the first visit (T1b) and at follow-up 7 to 9 weeks after T0 (T2) 1.3. Interoceptive global Metacognitive sensitivity measured by the HRD task at T0, T1b and T2 1.4 Interoception sensibility measured using the total score of “Multidimensional Assessment of Interoceptive Awareness” (MAIA) and its specific self-regulatory subscale at T0, T1b and T2 2. Measures of mental-health-related symptoms: 2.1. Disordered eating symptoms sum score measured using EDI-3 sub-scales (drive for thinness, bulimia and body dissatisfaction) at T0, T1b and T2 2.2. Self-reported psychological symptoms measured using the General Score Index of the BSI-53 and its specific sub-scales on somatisation symptoms, anxiety and depression at T0, T1b and T2 2.3. Affective and Interpersonal problems related to eating disorders measured using interoceptive deficits scale (EDI-3) at T0, T1b and T2 2.4. Emotional regulation measured using the Difficulties in emotion regulation scale (DERS) at T0, T1b and T2 3. Measures of Potential Moderators: 3.1. Core dimensions of obsessive compulsive disorder (OCD) harm avoidance and incompleteness as measured by OC-CDQ scoring at T0 3.2. Difficulty dealing with uncertainty measured using Intolerance for Uncertainty (IUS) scoring at T0 3.3. Measures of cardiac physiology measured using heart rate variability HRV at T0, T1b and T2

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026