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| ID | Type | Description | Link |
|---|---|---|---|
| 10.17605/OSF.IO/4UKFW | Other Identifier | OSF |
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The purpose of this study is to explore the potential therapeutic benefits of the Purrble intervention, a tangible device designed to assist with in-situ emotion regulation, for individuals on the South London and Maudsley NHS Trust (SLaM) Eating Disorders outpatient service waiting list. By examining its effects on emotion regulation, sensory sensitivity, depression, anxiety, and motivation for treatment engagement, the study seeks to offer empirical evidence on the efficacy of the Purrble as a supportive tool while patients are on the waiting list for formal outpatient treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group (Purrble) | Experimental | Participants in this group will be provided with the Purrble device, while waitlisted for eating disorder treatment. |
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| Control Group | No Intervention | The control condition will be waitlist as usual. Participants in this arm will not receive the Purrble intervention and will serve as a reference group for comparison. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Purrble | Device | The intervention takes the form of an interactive plush toy, which was co-designed with children to support in-the-moment soothing. The device is framed as an anxious creature, in need of care and attention when it feels distressed. This distress is indicated by a simulated heartbeat using embedded electronics to produce vibration patterns of i) frantic and anxious, to ii) slow, steady and relaxed. When held, the device emits a frantic heartbeat which can be slowed by stroking movements registered by embedded sensors. Once the device has been "soothed" for long enough, the heartbeat transitions into a purring vibration indicating a relaxed state. This transition can be achieved in under 1 minute but is dependent on the device-human interaction. |
| Measure | Description | Time Frame |
|---|---|---|
| Difficulties in Emotion Regulation Scale DERS-8 | DERS-8 is a unidimensional measure of emotion regulation difficulties in adolescents and adults. | From enrollment to the end of intervention at 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kate Tchantura, PhD | King's College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| South London and Maudsley NHS Foundation Trust | London | SE5 8AZ | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34751666 | Background | Slovak P, Ford BQ, Widen S, Dauden Roquet C, Theofanopoulou N, Gross JJ, Hankin B, Klasnja P. An In Situ, Child-Led Intervention to Promote Emotion Regulation Competence in Middle Childhood: Protocol for an Exploratory Randomized Controlled Trial. JMIR Res Protoc. 2021 Nov 9;10(11):e28914. doi: 10.2196/28914. | |
| 32326069 | Background |
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IPD sharing may be considered in the future upon request and pending appropriate approvals.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 12, 2023 | May 28, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 5, 2024 | May 28, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D001068 | Feeding and Eating Disorders |
| D000067877 | Autism Spectrum Disorder |
| D001321 | Autistic Disorder |
| D000080103 | Emotional Regulation |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
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| Kinnaird E, Dandil Y, Li Z, Smith K, Pimblett C, Agbalaya R, Stewart C, Tchanturia K. Pragmatic Sensory Screening in Anorexia Nervosa and Associations with Autistic Traits. J Clin Med. 2020 Apr 20;9(4):1182. doi: 10.3390/jcm9041182. |
| 24411653 | Background | Brockmeyer T, Skunde M, Wu M, Bresslein E, Rudofsky G, Herzog W, Friederich HC. Difficulties in emotion regulation across the spectrum of eating disorders. Compr Psychiatry. 2014 Apr;55(3):565-71. doi: 10.1016/j.comppsych.2013.12.001. Epub 2013 Dec 7. |
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D000068356 | Self-Control |
| D012919 | Social Behavior |
| D001519 | Behavior |