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Active, Not Recruiting

NCT Number: NCT07007481

Purrble's Soothing Touch for Eating Disorders and Autism

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

South London and Maudsley NHS Foundation Trust

London, SE5 8AZ, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Difficulties in Emotion Regulation Scale DERS-8

    Time frame: From enrollment to the end of intervention at 4 weeks

    DERS-8 is a unidimensional measure of emotion regulation difficulties in adolescents and adults.

Sponsors and collaborators

Lead sponsor

King's College London

Other

Registry information

Official study title

SOOTH-ED: Purrble's Soothing Touch for Eating Disorders and Autism

Acronym: SOOTH-ED

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 5, 2025
Registry last updated
Jun 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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