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ID
Source
Brief title
Health condition
Borderline personality disorder
Sponsors and support
Intervention
Outcome measures
Primary outcome
Body awareness (MAIA-2)
Secondary outcome
Emotion regulation (DERS)
Background summary
The current study will examine the feasibility, acceptance and potential (clinical) added value of Sense-IT, an ambulatory biofeedback (heart rate based) application for smartwatch and smartphone, for patients with borderline personality disorder.
Study objective
1. Patients with BPD experience the Sense-IT as user friendly.
2. Patients with BPD accept the Sense-IT technology, measured in compliance and satisfaction.
3. Therapists are satisfied with the use of Sense-IT during treatment.
4. Sense-IT improves body-awareness in patients with BPD.
5. Sense-IT improves emotion regulation in patients with BPD.
Study design
The baseline duration will vary from 2 to 6 weeks over the participants, with participants randomly allocated to baseline lengths. The SENSE-IT intervention consists of 2 weeks. The last phase is a 2 weeks follow-up phase.
Intervention
The Sense-IT consists of an application with two sides:
1. The smartwatch side of the application displays heart rate as measured by the smartwatch internal sensors on a scale from 1 to 10. At first use, an individual mean baseline heart rate and standard deviation during rest is determined. Then a threshold criterion can be established for informing users of rising and falling heart rates (i.e. a change of .5, 1 or 1.5 times the standard deviation). The user is visually and (optionally) tactilely informed of this change via the watch. The smartwatch application serves as a monitor to become aware of the change in heart rate where changes are only indicated when subjects are not involved in medium to intense physical activity as measured with the on-board accelerometer.
2. The smartphone side of the application: after the smartwatch vibrated as a signal of a significant change in heart rate, the smartphone application serves as a diary that can be used to make notes about the change in physiological arousal.
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
1) is admitted to inpatient care at Scelta, GGNet, Apeldoorn
2) is diagnosed with BPD according to DSM-5 criteria (APA, 2013)
3) is mentally competent and willing to participate in the study
Exclusion criteria
Patients
A potential subject who meets any of the following criteria will be excluded from participation in this study:
1) is unable to read, speak or write the Dutch language
2) is using beta-blockers
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9597 |
| CCMO | NL65285.044.18 |
| OMON | NL-OMON50372 |