Purrble's Soothing Touch for Eating Disorders and Autism

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-08

Study Completion Date

2025-11-30

Brief Summary

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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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Detailed Description

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Conditions

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Eating Disorders Autism Spectrum Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Intervention Group (Purrble)

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

Group Type EXPERIMENTAL

Purrble

Intervention Type 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.

Control Group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Purrble

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 Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No