Purrble's Soothing Touch for Eating Disorders and Autism
SOOTH-ED
SOOTH-ED: Purrble's Soothing Touch for Eating Disorders and Autism
2 other identifiers
interventional
200
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 8, 2024
CompletedFirst Submitted
Initial submission to the registry
May 28, 2025
CompletedFirst Posted
Study publicly available on registry
June 5, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2025
CompletedJune 5, 2025
May 1, 2025
1.6 years
May 28, 2025
May 28, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Intervention Group (Purrble)
EXPERIMENTALParticipants in this group will be provided with the Purrble device, while waitlisted for eating disorder treatment.
Control Group
NO INTERVENTIONThe 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Currently enrolled on the South London and Maudsley NHS Foundation Trust (SLaM) Eating Disorders Outpatient Service waiting list
- Confirmed diagnosis of an ED.
- Participants aged 18 and above.
- Willing to commit to the duration of the study and provide informed consent.
You may not qualify if:
- Individuals currently dealing with substance abuse issues.
- Individuals with active psychosis.
- Individuals currently experiencing high suicidality or deemed to be at a high risk of self-harm.
- Individuals currently undergoing a separate ED treatment.
- Individuals who have previously been exposed to the Purrble intervention.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
South London and Maudsley NHS Foundation Trust
London, SE5 8AZ, United Kingdom
Related Publications (3)
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.
PMID: 34751666BACKGROUNDKinnaird 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.
PMID: 32326069BACKGROUNDBrockmeyer 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.
PMID: 24411653BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kate Tchantura, PhD
King's College London
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 28, 2025
First Posted
June 5, 2025
Study Start
February 8, 2024
Primary Completion
October 1, 2025
Study Completion
November 30, 2025
Last Updated
June 5, 2025
Record last verified: 2025-05