Emotion RegulationNCT06025942
Purrble With LGBTQ+ Youth Who Have Self-harmful Thoughts
A study testing Purrble intervention in people with Emotion Regulation and Self Harm, run by King's College London at 1 site in United Kingdom.
Trial summary
The primary aim of the proposed Randomised Control study is to investigate the effects of a socially assisted robot (i.e. Purrble) on emotional regulation difficulties (measured by DERS8) with young LGBTQ+ people who have self-harmful (with or without suicidal intention) (in comparison to a wait-listed control). Read more about this study
- Who is it for?
- Ages 16 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Emotion Regulation, Self Harm
- What is being tested?
- Purrble intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 Jan 2024to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 16 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Currently experiencing self-harmful thoughts (within the last month) Identify as sexual orientation or gender identity minority (LGBTQ+) Aged 16-25 years Currently living in the UK at the time of the study Able to read and write in English
Who cannot join
- Young people who live outside the UK, are not within the 16-25 year age bracket, and are not experiencing self-harmful thoughts will not be included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Enhancing Emotion Regulation With an In-situ Socially Assistive Robot Among LGBTQ+ Youth With Self-harm Ideation: a Randomised Control Trial
The primary aim of the proposed Randomised Control study is to investigate the effects of a socially assisted robot (i.e. Purrble) on emotional regulation difficulties (measured by DERS8) with young LGBTQ+ people who have self-harmful (with or without suicidal intention) (in comparison to a wait-listed control).
Secondary aims include investigating the effects of the Purrble on young people's self-harmful thoughts, symptoms of anxiety and depression, alongside quantitative and qualitative (interviews) measures of engagement with the intervention.
Read the detailed description
Self-harm is a key concern among young people, this is highlighted by the rising rates self-harm and suicide attempts in recent years. Internationally, young LGBTQ+ people are recognised to report higher prevalence of self-harmful thoughts, behaviours, anxiety and depression than their cisgender, heterosexual peers. Emotion regulation (ER) is known to be a transdiagnostic risk factor, which is widely associated with higher risk of self-harm. Typically, LGBTQ+ populations also report greater difficulties with ER which partially explains association with self-harm.
While LGBTQ+ youth are frequent users of digital technologies and digital interventions are often considered feasible and acceptable, there is limited evidence of the effectiveness of such within these populations. Currently, there is no evidence-based digital interventions targeting LGBTQ+ youth who struggle with self-harm.
To address this gap, the investigators have conducted a small pilot study (n=21) to evaluated one such possible tool - Purrble - as a means to offer in-the-moment emotional support for those with high levels of self-harm risk (high symptoms of anxiety, depression, or self-harmful experiences in the last 6 months). The goals of the study centre around testing the feasibility, acceptability, and usage of Purrble across a 2-week deployment period. These results have been promising, indicating Purrble as a feasible and acceptable intervention, alongside indicators of clinical value during Purrble deployment: i) reduction of anxiety and depression symptoms during deployment and ii) reduced prevalence of self-harm thoughts.
From previous interviews, participants highlighted the positive outcomes which were associated with Purrble use (stopping them reaching the point of thinking about self-harm, being a barrier to self-harm behaviours, and encouraging emotional regulation coping strategies; e.g. grounding, self-soothing). However, these pilot studies did not include a controlled waitlist group, and thus more rigorous investigation of these promising effects is needed - leading to the current study.
- Conditions
- Emotion Regulation, Self Harm
- Being tested
- Purrble intervention
- Keywords
- LGBTQ, Self-harm, Emotion regulation, Young people, RCT
- Medical subject headings
- Emotional Regulation, Self-Injurious Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Purrble interventionBehavioural
When the Purrble is picked up, it emits a frantic heartbeat that slows down if the person uses calm stroking movements. If the Purrble is soothed for long enough, it transitions into a purring vibration indicating a calm, content state.
Logic model underlying the intervention:
Level 1: in-the-moment soothing support to young people in emotional moments when they would attempt to utilise emotion regulation (ER) strategies to calm down.
Level 2: mechanisms that facilitate long-term engagement with the intervention, building on positive subjective experience of Level 1.
Level 3: shift in young peoples' ER practices and implicit beliefs about emotion, after repeated experience of Levels 1-2.
- see JMIR Res Protoc 2021;10(11):e28914 (doi: 10.2196/28914)
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The Purrble intervention takes the form of an interactive plush toy, designed to be handed over to the young person and support in-the-moment soothing. Receives: Behavioral: Purrble intervention |
| Control | No intervention | Wait-list control (access to services as usual) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emotion regulation (DERS8)
Across the trial, we hypothesise that access to the Purrble intervention (compared to the waitlist control) will lead to a decrease in self-reported difficulties with emotion regulation as measured by the primary outcome (DERS8). We will compare the DERS8 assessment pre-deployment (calculated as the average of DERS scores across baseline weeks 1-3) and final deployment assessments (averaged across weeks 11-13).
Measured by: Difficulties with Emotional Regulation Scale-8 (DERS8), an 8-item instrument used to measure or assess the difficulties with regulating emotion [22].
The DERS8 score is calculated using a 5-point Likert scale, ranging from 1 (almost never, 0-10%) to 5 (almost always 91-100%). These scores are added together to form a total score (8-40). Higher scores indicate greater levels of difficulty associated with response to situations eliciting negative emotions.
Measured: all timepoints [Time Frame: Three times during pre-deployment (week 1-3) and ten times during the 10-week long deployment period (week 4-13) = total of 13 times]
Secondary outcomes (3)
Self-harmful thoughts (SHQ)
A secondary aim to evaluate the impact of the Purrble intervention on young LGBTQ+ people's self-harmful ideation (with and without suicidal intention), compared to waiting list controls.
Measured by: The Self-Harm Questionnaire (SHQ; [23]). While the whole instrument is used at baseline (T0), offering a greater level of detail as to why someone has self-harmed, and only the three screener items will be used across deployment. These question the presence of self-harmful thoughts (without suicidal intentions), suicidal thoughts, and whether the young person has harmed themselves on purpose. The screener assigns scores of 1 (no), 2 (yes, once), 3 (yes, two, three or four times), and 4 (yes, five or more times) - offering a general idea of frequency of self-harmful thoughts.
Measured: all timepoints [Time Frame: Three times during pre-deployment (week 1-3) and ten times during the 10-week long deployment period (week 4-12) = total of 13 times]
Anxiety (GAD7)
A secondary aim is to investigate the effects of Purrble on reports of anxiety symptoms within young LGBTQ+ people who have current experiences of self-harmful ideation (in comparison to a wait-listed group).
Measured by: Generalised Anxiety Disorder Assessment (GAD-7; [24]), a seven-item instrument that is used to measure or assess the severity of generalised anxiety disorder. Each item asks the individual to rate the severity of their symptoms over the past two weeks.
The GAD-7 score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of "not at all," "several days," "more than half the days," and "nearly every day," respectively, and then adding together the scores for the seven questions (score range: 0-21). Scores of 5, 10, and 15 represent cut-points for mild, moderate, and severe anxiety, respectively.
Measured: all timepoints [Time Frame: Three times during pre-deployment (week 1-3) and ten times during the 10-week long deployment period (week 4-13) = total of 13 times]
Depression (PHQ-9)
A secondary aim is to investigate the effects of Purrble on reports of depressive symptoms within young people who have current experiences of self-harmful ideation (in comparison to a wait-listed group).
Measured by: Patient Health Questionnaire-9 (PHQ-9; [25]) , a depression module which scores each of the nine DSM-IV criteria as "0" (not at all) to "3" (nearly every day). It is not a screening tool for depression but it is used to monitor the severity of depression and response to treatment. The maximum score is 27 (9 questions x maximum 3 points per question). Depression severity is graded based on the PHQ-9 score: None 0-4 Mild 5-9 Moderately 10-14 Moderately severe 15-19 Severe 20-27.
Measured: all timepoints [Time Frame: Three times during pre-deployment (week 1-3) and ten times during the 10-week long deployment period (week 4-13) = total of 13 times]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study start11 Jan 2024
- Primary completion23 Oct 2024
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Emotion RegulationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oxford, University of Nottingham, University of Glasgow, Stanford University, University of Melbourne
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06025942
- Sponsor's protocol ID
- RESCM-22/23-34570
- Status last verified
- Mar 2025
- First submitted
- 29 Aug 2023
- Last updated
- 4 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be available upon reasonable request once the trial is complete. To date there is no data that has been collected or analysed for this study. The data will be held at King's College London, following the data management agreement of Digital Youth.
Publications
Gillies D, Christou MA, Dixon AC, Featherston OJ, Rapti I, Garcia-Anguita A, Villasis-Keever M, Reebye P, Christou E, Al Kabir N, Christou PA. Prevalence and Characteristics of Self-Harm in Adolescents: Meta-Analyses of Community-Based Studies 1990-2015. J Am Acad Child Adolesc Psychiatry. 2018 Oct;57(10):733-741. doi: 10.1016/j.jaac.2018.06.018. Epub 2018 Aug 21.
PubMed 30274648Griffin E, McMahon E, McNicholas F, Corcoran P, Perry IJ, Arensman E. Increasing rates of self-harm among children, adolescents and young adults: a 10-year national registry study 2007-2016. Soc Psychiatry Psychiatr Epidemiol. 2018 Jul;53(7):663-671. doi: 10.1007/s00127-018-1522-1. Epub 2018 May 2.
PubMed 29721594Coker TR, Austin SB, Schuster MA. The health and health care of lesbian, gay, and bisexual adolescents. Annu Rev Public Health. 2010;31:457-77. doi: 10.1146/annurev.publhealth.012809.103636.
PubMed 20070195Haas AP, Eliason M, Mays VM, Mathy RM, Cochran SD, D'Augelli AR, Silverman MM, Fisher PW, Hughes T, Rosario M, Russell ST, Malley E, Reed J, Litts DA, Haller E, Sell RL, Remafedi G, Bradford J, Beautrais AL, Brown GK, Diamond GM, Friedman MS, Garofalo R, Turner MS, Hollibaugh A, Clayton PJ. Suicide and suicide risk in lesbian, gay, bisexual, and transgender populations: review and recommendations. J Homosex. 2011;58(1):10-51. doi: 10.1080/00918369.2011.534038.
PubMed 21213174Marshal MP, Dietz LJ, Friedman MS, Stall R, Smith HA, McGinley J, Thoma BC, Murray PJ, D'Augelli AR, Brent DA. Suicidality and depression disparities between sexual minority and heterosexual youth: a meta-analytic review. J Adolesc Health. 2011 Aug;49(2):115-23. doi: 10.1016/j.jadohealth.2011.02.005. Epub 2011 May 26.
PubMed 21783042Saewyc EM. RESEARCH ON ADOLESCENT SEXUAL ORIENTATION: DEVELOPMENT, HEALTH DISPARITIES, STIGMA AND RESILIENCE. J Res Adolesc. 2011 Feb 15;21(1):256-272. doi: 10.1111/j.1532-7795.2010.00727.x.
PubMed 27099454McDermott E, Hughes E, Rawlings V. Norms and normalisation: understanding lesbian, gay, bisexual, transgender and queer youth, suicidality and help-seeking. Cult Health Sex. 2018 Feb;20(2):156-172. doi: 10.1080/13691058.2017.1335435. Epub 2017 Jun 23.
PubMed 28641479Irish M, Solmi F, Mars B, King M, Lewis G, Pearson RM, Pitman A, Rowe S, Srinivasan R, Lewis G. Depression and self-harm from adolescence to young adulthood in sexual minorities compared with heterosexuals in the UK: a population-based cohort study. Lancet Child Adolesc Health. 2019 Feb;3(2):91-98. doi: 10.1016/S2352-4642(18)30343-2. Epub 2018 Dec 12.
PubMed 30552054Chan MK, Bhatti H, Meader N, Stockton S, Evans J, O'Connor RC, Kapur N, Kendall T. Predicting suicide following self-harm: systematic review of risk factors and risk scales. Br J Psychiatry. 2016 Oct;209(4):277-283. doi: 10.1192/bjp.bp.115.170050. Epub 2016 Jun 23.
PubMed 27340111Sloan E, Hall K, Moulding R, Bryce S, Mildred H, Staiger PK. Emotion regulation as a transdiagnostic treatment construct across anxiety, depression, substance, eating and borderline personality disorders: A systematic review. Clin Psychol Rev. 2017 Nov;57:141-163. doi: 10.1016/j.cpr.2017.09.002. Epub 2017 Sep 11.
PubMed 28941927Wolff JC, Thompson E, Thomas SA, Nesi J, Bettis AH, Ransford B, Scopelliti K, Frazier EA, Liu RT. Emotion dysregulation and non-suicidal self-injury: A systematic review and meta-analysis. Eur Psychiatry. 2019 Jun;59:25-36. doi: 10.1016/j.eurpsy.2019.03.004. Epub 2019 Apr 12.
PubMed 30986729Fox KR, Franklin JC, Ribeiro JD, Kleiman EM, Bentley KH, Nock MK. Meta-analysis of risk factors for nonsuicidal self-injury. Clin Psychol Rev. 2015 Dec;42:156-67. doi: 10.1016/j.cpr.2015.09.002. Epub 2015 Sep 12.
PubMed 26416295Kapatais A, Williams AJ, Townsend E. The Mediating Role of Emotion Regulation on Self-harm among Gender Identity and Sexual Orientation Minority (LGBTQ+) Individuals. Arch Suicide Res. 2023 Apr-Jun;27(2):165-178. doi: 10.1080/13811118.2022.2064254. Epub 2022 Apr 21.
PubMed 35446245Fraser G, Wilson MS, Garisch JA, Robinson K, Brocklesby M, Kingi T, O'Connell A, Russell L. Non-Suicidal Self-Injury, Sexuality Concerns, and Emotion Regulation among Sexually Diverse Adolescents: A Multiple Mediation Analysis. Arch Suicide Res. 2018 Jul-Sep;22(3):432-452. doi: 10.1080/13811118.2017.1358224. Epub 2017 Sep 7.
PubMed 28759324Steinke J, Root-Bowman M, Estabrook S, Levine DS, Kantor LM. Meeting the Needs of Sexual and Gender Minority Youth: Formative Research on Potential Digital Health Interventions. J Adolesc Health. 2017 May;60(5):541-548. doi: 10.1016/j.jadohealth.2016.11.023. Epub 2017 Jan 17.
PubMed 28108088
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Emotion Regulation With an In-situ Socially Assistive Robot Among LGBTQ+ Youth With Self-harm Ideation: a Randomised Control Trial
- ClinicalTrials.gov ID
- NCT06025942
- Acronym / sponsor ID
- RESCM-22/23-34570
- Conditions
- Emotion Regulation, Self Harm
- Keywords
- LGBTQ, Self-harm, Emotion regulation, Young people, RCT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- University of Oxford, University of Nottingham, University of Glasgow, Stanford University, University of Melbourne
- Study start
- 11 Jan 2024 (actual)
- Primary completion
- 23 Oct 2024 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 6 Sep 2023 (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 primary aim of the proposed Randomised Control study is to investigate the effects of a socially assisted robot (i.e. Purrble) on emotional regulation difficulties (measured by DERS8) with young LGBTQ+ people who have self-harmful (with or without suicidal intention) (in comparison to a wait-listed control).
Secondary aims include investigating the effects of the Purrble on young people's self-harmful thoughts, symptoms of anxiety and depression, alongside quantitative and qualitative (interviews) measures of engagement with the intervention.
Detailed description
Self-harm is a key concern among young people, this is highlighted by the rising rates self-harm and suicide attempts in recent years. Internationally, young LGBTQ+ people are recognised to report higher prevalence of self-harmful thoughts, behaviours, anxiety and depression than their cisgender, heterosexual peers. Emotion regulation (ER) is known to be a transdiagnostic risk factor, which is widely associated with higher risk of self-harm. Typically, LGBTQ+ populations also report greater difficulties with ER which partially explains association with self-harm.
While LGBTQ+ youth are frequent users of digital technologies and digital interventions are often considered feasible and acceptable, there is limited evidence of the effectiveness of such within these populations. Currently, there is no evidence-based digital interventions targeting LGBTQ+ youth who struggle with self-harm.
To address this gap, the investigators have conducted a small pilot study (n=21) to evaluated one such possible tool - Purrble - as a means to offer in-the-moment emotional support for those with high levels of self-harm risk (high symptoms of anxiety, depression, or self-harmful experiences in the last 6 months). The goals of the study centre around testing the feasibility, acceptability, and usage of Purrble across a 2-week deployment period. These results have been promising, indicating Purrble as a feasible and acceptable intervention, alongside indicators of clinical value during Purrble deployment: i) reduction of anxiety and depression symptoms during deployment and ii) reduced prevalence of self-harm thoughts.
From previous interviews, participants highlighted the positive outcomes which were associated with Purrble use (stopping them reaching the point of thinking about self-harm, being a barrier to self-harm behaviours, and encouraging emotional regulation coping strategies; e.g. grounding, self-soothing). However, these pilot studies did not include a controlled waitlist group, and thus more rigorous investigation of these promising effects is needed - leading to the current study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Purrble interventionThe Purrble intervention takes the form of an interactive plush toy, designed to be handed over to the young person and support in-the-moment soothing. |
| Control | No intervention | –Wait-list control (access to services as usual) |
Who may qualify
- Ages
- 16 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Currently experiencing self-harmful thoughts (within the last month) Identify as sexual orientation or gender identity minority (LGBTQ+) Aged 16-25 years Currently living in the UK at the time of the study Able to read and write in English
Key exclusion criteria (1 listed)
- Young people who live outside the UK, are not within the 16-25 year age bracket, and are not experiencing self-harmful thoughts will not be included in the study.
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 |
|---|---|---|
| Purrble interventionWhen the Purrble is picked up, it emits a frantic heartbeat that slows down if the person uses calm stroking movements. If the Purrble is soothed for long enough, it transitions into a purring vibration indicating a calm, content state. Logic model underlying the intervention: Level 1: in-the-moment soothing support to young people in emotional moments when they would attempt to utilise emotion regulation (ER) strategies to calm down. Level 2: mechanisms that facilitate long-term engagement with the intervention, building on positive subjective experience of Level 1. Level 3: shift in young peoples' ER practices and implicit beliefs about emotion, after repeated experience of Levels 1-2. * see JMIR Res Protoc 2021;10(11):e28914 (doi: 10.2196/28914) | Behavioural | Intervention |
Primary outcome
Emotion regulation (DERS8)
Time frame: all timepoints [Time Frame: Three times during pre-deployment (week 1-3) and ten times during the 10-week long deployment period (week 4-13) = total of 13 times]
Across the trial, we hypothesise that access to the Purrble intervention (compared to the waitlist control) will lead to a decrease in self-reported difficulties with emotion regulation as measured by the primary outcome (DERS8). We will compare the DERS8 assessment pre-deployment (calculated as the average of DERS scores across baseline weeks 1-3) and final deployment assessments (averaged across weeks 11-13). Measured by: Difficulties with Emotional Regulation Scale-8 (DERS8), an 8-item instrument used to measure or assess the difficulties with regulating emotion [22]. The DERS8 score is calculated using a 5-point Likert scale, ranging from 1 (almost never, 0-10%) to 5 (almost always 91-100%). These scores are added together to form a total score (8-40). Higher scores indicate greater levels of difficulty associated with response to situations eliciting negative emotions.
3 secondary outcomes
Self-harmful thoughts (SHQ)
Time frame: all timepoints [Time Frame: Three times during pre-deployment (week 1-3) and ten times during the 10-week long deployment period (week 4-12) = total of 13 times]
Anxiety (GAD7)
Time frame: all timepoints [Time Frame: Three times during pre-deployment (week 1-3) and ten times during the 10-week long deployment period (week 4-13) = total of 13 times]
Depression (PHQ-9)
Time frame: all timepoints [Time Frame: Three times during pre-deployment (week 1-3) and ten times during the 10-week long deployment period (week 4-13) = total of 13 times]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
- Background: PubMed 30274648Gillies D, Christou MA, Dixon AC, Featherston OJ, Rapti I, Garcia-Anguita A, Villasis-Keever M, Reebye P, Christou E, Al Kabir N, Christou PA. Prevalence and Characteristics of Self-Harm in Adolescents: Meta-Analyses of Community-Based Studies 1990-2015. J Am Acad Child Adolesc Psychiatry. 2018 Oct;57(10):733-741. doi: 10.1016/j.jaac.2018.06.018. Epub 2018 Aug 21.
- Background: PubMed 29721594Griffin E, McMahon E, McNicholas F, Corcoran P, Perry IJ, Arensman E. Increasing rates of self-harm among children, adolescents and young adults: a 10-year national registry study 2007-2016. Soc Psychiatry Psychiatr Epidemiol. 2018 Jul;53(7):663-671. doi: 10.1007/s00127-018-1522-1. Epub 2018 May 2.
- Background: PubMed 20070195Coker TR, Austin SB, Schuster MA. The health and health care of lesbian, gay, and bisexual adolescents. Annu Rev Public Health. 2010;31:457-77. doi: 10.1146/annurev.publhealth.012809.103636.
- Background: PubMed 21213174Haas AP, Eliason M, Mays VM, Mathy RM, Cochran SD, D'Augelli AR, Silverman MM, Fisher PW, Hughes T, Rosario M, Russell ST, Malley E, Reed J, Litts DA, Haller E, Sell RL, Remafedi G, Bradford J, Beautrais AL, Brown GK, Diamond GM, Friedman MS, Garofalo R, Turner MS, Hollibaugh A, Clayton PJ. Suicide and suicide risk in lesbian, gay, bisexual, and transgender populations: review and recommendations. J Homosex. 2011;58(1):10-51. doi: 10.1080/00918369.2011.534038.
- Background: PubMed 21783042Marshal MP, Dietz LJ, Friedman MS, Stall R, Smith HA, McGinley J, Thoma BC, Murray PJ, D'Augelli AR, Brent DA. Suicidality and depression disparities between sexual minority and heterosexual youth: a meta-analytic review. J Adolesc Health. 2011 Aug;49(2):115-23. doi: 10.1016/j.jadohealth.2011.02.005. Epub 2011 May 26.
- Background: PubMed 27099454Saewyc EM. RESEARCH ON ADOLESCENT SEXUAL ORIENTATION: DEVELOPMENT, HEALTH DISPARITIES, STIGMA AND RESILIENCE. J Res Adolesc. 2011 Feb 15;21(1):256-272. doi: 10.1111/j.1532-7795.2010.00727.x.
- Background: PubMed 28641479McDermott E, Hughes E, Rawlings V. Norms and normalisation: understanding lesbian, gay, bisexual, transgender and queer youth, suicidality and help-seeking. Cult Health Sex. 2018 Feb;20(2):156-172. doi: 10.1080/13691058.2017.1335435. Epub 2017 Jun 23.
- Background: PubMed 30552054Irish M, Solmi F, Mars B, King M, Lewis G, Pearson RM, Pitman A, Rowe S, Srinivasan R, Lewis G. Depression and self-harm from adolescence to young adulthood in sexual minorities compared with heterosexuals in the UK: a population-based cohort study. Lancet Child Adolesc Health. 2019 Feb;3(2):91-98. doi: 10.1016/S2352-4642(18)30343-2. Epub 2018 Dec 12.
- Background: PubMed 27340111Chan MK, Bhatti H, Meader N, Stockton S, Evans J, O'Connor RC, Kapur N, Kendall T. Predicting suicide following self-harm: systematic review of risk factors and risk scales. Br J Psychiatry. 2016 Oct;209(4):277-283. doi: 10.1192/bjp.bp.115.170050. Epub 2016 Jun 23.
- Background: PubMed 28941927Sloan E, Hall K, Moulding R, Bryce S, Mildred H, Staiger PK. Emotion regulation as a transdiagnostic treatment construct across anxiety, depression, substance, eating and borderline personality disorders: A systematic review. Clin Psychol Rev. 2017 Nov;57:141-163. doi: 10.1016/j.cpr.2017.09.002. Epub 2017 Sep 11.
- Background: PubMed 30986729Wolff JC, Thompson E, Thomas SA, Nesi J, Bettis AH, Ransford B, Scopelliti K, Frazier EA, Liu RT. Emotion dysregulation and non-suicidal self-injury: A systematic review and meta-analysis. Eur Psychiatry. 2019 Jun;59:25-36. doi: 10.1016/j.eurpsy.2019.03.004. Epub 2019 Apr 12.
- Background: PubMed 26416295Fox KR, Franklin JC, Ribeiro JD, Kleiman EM, Bentley KH, Nock MK. Meta-analysis of risk factors for nonsuicidal self-injury. Clin Psychol Rev. 2015 Dec;42:156-67. doi: 10.1016/j.cpr.2015.09.002. Epub 2015 Sep 12.
- Individual participant dataSharing planned: Yes. Data will be available upon reasonable request once the trial is complete. To date there is no data that has been collected or analysed for this study. The data will be held at King's College London, following the data management agreement of Digital Youth.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 intervention in people with Emotion Regulation and Self Harm, 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 4 Mar 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Emotion regulation (DERS8) (time frame: all timepoints [Time Frame: Three times during pre-deployment (week 1-3) and ten times during the 10-week long deployment period (week 4-13) = total of 13 times]). 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 NCT06025942, which also lists 27 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 4 Mar 2025.