Eating DisordersSOOTH-EDNCT07007481
Purrble's Soothing Touch for Eating Disorders and Autism
A study testing Purrble in people with Eating Disorders and Autism Spectrum Disorder, run by King's College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Eating Disorders, Autism Spectrum Disorder
- What is being tested?
- Purrble
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 Feb 2024to 30 Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
South London and Maudsley NHS Foundation Trust
London, SE5 8AZ
About this study
Official title: SOOTH-ED: 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.
- Conditions
- Eating Disorders, Autism Spectrum Disorder
- Being tested
- Purrble
- Keywords
- Eating Disorders, Autism, Sensory Porcessing, Emotion Regulation, Purrble
- Medical subject headings
- Feeding and Eating Disorders, Autism Spectrum Disorder, Autistic Disorder, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group (Purrble) | Experimental | Participants in this group will be provided with the Purrble device, while waitlisted for eating disorder treatment. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difficulties in Emotion Regulation Scale DERS-8
DERS-8 is a unidimensional measure of emotion regulation difficulties in adolescents and adults.
Measured: From enrollment to the end of intervention at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start8 Feb 2024
- Primary completionOct 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Eating DisordersStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kate Tchantura, PhD, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07007481
- Sponsor's protocol ID
- 333898
- Other IDs
- 10.17605/OSF.IO/4UKFW
- Acronym
- SOOTH-ED
- Status last verified
- May 2025
- First submitted
- 28 May 2025
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD sharing may be considered in the future upon request and pending appropriate approvals.
Publications
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.
PubMed 34751666Kinnaird 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.
PubMed 32326069Brockmeyer 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.
PubMed 24411653
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SOOTH-ED: Purrble's Soothing Touch for Eating Disorders and Autism
- ClinicalTrials.gov ID
- NCT07007481
- Acronym / sponsor ID
- SOOTH-ED / 333898
- Conditions
- Eating Disorders, Autism Spectrum Disorder
- Keywords
- Eating Disorders, Autism, Sensory Porcessing, Emotion Regulation, Purrble
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- 8 Feb 2024 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 5 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group (Purrble) | Experimental | Device: PurrbleParticipants in this group will be provided with the Purrble device, while waitlisted for eating disorder treatment. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PurrbleThe 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. | Device | Intervention Group (Purrble) |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- Background: PubMed 34751666Slovak 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.
- Background: PubMed 32326069Kinnaird 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.
- Background: PubMed 24411653Brockmeyer 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.
- Individual participant dataSharing planned: Undecided. IPD sharing may be considered in the future upon request and pending appropriate approvals.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kate Tchantura, PhD principal investigator
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Purrble in people with Eating Disorders and Autism Spectrum Disorder, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difficulties in Emotion Regulation Scale DERS-8 (time frame: From enrollment to the end of intervention at 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07007481, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2025.