NCT07007481

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

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

May 28, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 5, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2025

Completed
Last Updated

June 5, 2025

Status Verified

May 1, 2025

Enrollment Period

1.6 years

First QC Date

May 28, 2025

Last Update Submit

May 28, 2025

Conditions

Keywords

Eating DisordersAutismSensory PorcessingEmotion RegulationPurrble

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)

EXPERIMENTAL

Participants in this group will be provided with the Purrble device, while waitlisted for eating disorder treatment.

Device: Purrble

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.

Interventions

PurrbleDEVICE

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.

Intervention Group (Purrble)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

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: 34751666BACKGROUND
  • 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.

    PMID: 32326069BACKGROUND
  • 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.

    PMID: 24411653BACKGROUND

MeSH Terms

Conditions

Feeding and Eating DisordersAutism Spectrum DisorderAutistic DisorderEmotional Regulation

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersChild Development Disorders, PervasiveNeurodevelopmental DisordersSelf-ControlSocial BehaviorBehavior

Study Officials

  • Kate Tchantura, PhD

    King's College London

    PRINCIPAL INVESTIGATOR

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

Locations