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Is it effective to implement a self-monitoring smartwatch with goals to improve interoceptive processes and mental wellbeing within an existing treatment for personality disorders?

Can Biocueing Technologies Enhance Interoceptive Processes among Individuals with Personality Disorders: A Optimization Pilot Study and Randomized-Controlled Single-Case Experimental Design follow-up - Biocueing Pilot

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON58144
Enrollment
11
Registered
2025-04-04
Start date
2026-02-03
Completion date
Unknown
Last updated
2026-06-22

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

Conditions

Borderline Personality Disorder, Emotion regulation disorder, unstable emotional personality disorder Unstable Emotional Personality Disorder, Emotional Dysregulation Disorder,

Interventions

Nowatch Wearable Technology The biocueing wearable to be used in this study is the Nowatch. Nowatch B.V. is a Dutch company that develops stress wearables. The wearable collects data obtained from a n
a purple line denotes stress unrelated to physical activity
and an orange line represents a combination of both stress and physical activity that cannot be accurately separated. Figure 1. Nowatch application displaying the stress gaugeBiocueing settings The No

Sponsors

GGNet
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Diagnosis of a borderline personality disorderIn possession of an android / IOs smartphone

Exclusion criteria

Exclusion criteria: Acute suïcidal episodePsychotic disorderBipolar disorderHypochrondriasis / anxious somatic preoccupation with body sensations

Design outcomes

Primary

MeasureTime frame
The primary outcome measure of this study is the assessment of interoceptive processes, as captured through Ecological Momentary Assessment.Ecological Momentary Assessment Ecological Momentary Assessment (EMA) is a method for capturing real-time, within-day fluctuations in psychological and physiological states. By assessing individuals in their natural environments, EMA provides a more ecologically valid representation of phenomena as they unfold in daily life. In this study, participants will receive randomized prompts throughout the day via the M-path mobile application, developed by KU Leuven, which supports ecological sampling through SMS and push notifications(Mestdagh et al., 2023). To achieve the preferred 80% compliance rates, it is necessary to find a balance between total duration (duration), the number of prompts per day (density), and the number of questions per prompt (depth). Given the length of the study period (42-49 days), a low number of prompts (three times a day) and few questions (six at a time) was deemed appropriate and somewhat similar to other EMA studies among individuals with BPD (Davanzo et al., 2023).The EMA questions were selected to capture momentary states rather than stable traits, as per best practices in EMA research. Participants will be provided with detailed instructions on how to use the EMA. They will be informed that, although the questions are phrased to capture momentary states (e.g., ‘at the moment’, ‘currently’), they are intended to assess participants’ experiences during the period immediately preceding the notification ('beep'), rather than at the exact moment of responding. Candidate items were drawn from the ESM Item Repository and adapted as needed in collaboration with field experts (Kirtley et al., 2024). Momentary Cardiac Interoceptive Attention In order to collect information on momentary cardiac interoceptive attention, a recent paper chose to design a Likert-scale question to capture momen

Secondary

MeasureTime frame
Self-report questionnaires Scale of Body Connection (SBC) The Scale of Body Connection assess interoceptive sensibility and consists of two subscales: body dissociation and body awareness. This instrument has been used in previous studies on interoception in individuals with BPD(Schmitz et al., 2021, 2023). The questionnaire contains two different subscales: body dissociation and body awareness. While the English version demonstrates good psychometric properties, the Dutch translation yields mixed reliability outcomes. The Body Awareness subscale demonstrates acceptable internal consistency (Cronbach’s a = .71 among students, a = .82 in primary care patients), whereas the Body Dissociation subscale shows only fair reliability (a = .64). Therefore, the Body Dissociation subscale was fair (a = .64), and therefore, will not be analyzed seperately. Multidimensional Assessment of Interoceptive Awareness-2 (MAIA-2) The MAIA-2 is a widely used 37-item self-report questionnaire designed to measure different areas of interoception. The questionnaire has good reliability and internal consistency(Mehling et al., 2012, 2018). The questionnaire contains 8 different subscales, including 'Noticing', 'Not-Distracting', 'Not-worrying, 'Attention regulation', 'Emotional awareness', 'Self-regulation', 'Body listening' and 'Trusting, with internal reliability (conbrach a ) ranging between .64 and .83. The Dutch version of the MAIA-2 has been validated and demonstrates good internal consistency and fair to good test-retest reliability (Scheffers et al., 2024). In this study, both the subscales and total scores will be examined.Brief Symptom Inventory The Brief Symptom Inventory is a widely used self-report questionnaires to broadly assess the intensity of psychiatric symptoms in the prior week(Derogatis & Melisaratos, 1983). The questionnaire consists of 53 items that can be divided into 9 subscales: somatisation, obsessive-compulsive, interpersonal sensitivity,

Countries

Netherlands

Contacts

Public ContactL.L. Lans

GGNet

L.L.Lans@utwente.nl088 933 1100

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jun 29, 2026