AnxietyNCT05376735

Randomised Control Trial of an Intervention to Promote Emotion Regulation Strategies in University Students

A study testing Purrble intervention and Single Session Intervention in people with Anxiety and Emotion Regulation, run by King's College London.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

The primary aim of the proposed Randomised Control study is to investigate the effects of a socially assisted robot (i.e. Purrble) and a bespoke Single Session Intervention (SSI) on students' anxiety (measured by GAD7) over the period of the academic term (in comparison to a wait-listed student group). Read more about this study

Who is it for?: Ages 18 to 25 yearsHealthy volunteers can take part
Conditions the study is for: Anxiety, Emotion Regulation
What is being tested?: Purrble intervention and Single Session Intervention
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: No sites listed yet
Study dates: 16 May 2022to 19 Sep 2022
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 18 to 25 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Currently registered as a student at Oxford University (under- or postgraduate) at the time of the study
Currently living in the UK at the time of the study
Aged 18-25
GAD7 score >= 10 (Löwe, 2008)
Consistent internet and computer/laptop/smartphone access
Able to read and write in English

Who cannot join

Not an Oxford University student currently living in the UK at the time of the study
Not within age range
GAD7 score < 10 (Löwe, 2008)

Trial locations and contacts

No sites are listed yet.

Petr Slovak, Dr contact

+44 020 7848 1988

petr.slovak@kcl.ac.uk

About this study

Official title: An Exploratory Randomised Control Trial of a Single Session Intervention Combined With In-situ Socially Assistive Robot to Promote Emotion Regulation Competence in University Students

Secondary aims include investigating the effects of the Purrble and SSI on students' depression, emotion regulation processes, and quantitative and qualitative (interviews) measures of engagement with the intervention.

Read the detailed description

Need among college students for accessible mental health support is high: for example, the WHO World Mental Health International College Student project,(Auerbach et al., 2018) involving 13,984 first-year college students from eight countries, found that 31% of the respondents screened positive for depression, anxiety, or alcohol use disorder. Yet, access to professional support has long remained low, with waitlists for counseling on many campuses being weeks to months long (cf., for example Brown 2018). Digital technologies, including apps, have been proposed as one possible means of 'filling in the gaps' in extant mental health care support for college students - but most apps suffer from low usability in real-world settings (Torous et al, 2018), are not equipped to serve in-the-moment coping needs (e.g., they involve user-initiated psychoeducation modules rather than opportunities to practice and grow skills when they are needed most) and often show high drop-out rates (Musiat et al, 2014).

There thus is a clear need to harness digital technologies to create usable, engaging, evidence-supported mental health supports that may be used flexibly based on when students need them most (e.g. when stress levels are particularly high and coping skills most warrant deployment); ideally also as an adjunct completing existing counselling service.

In the pilot work last year (n=80, open trial at Oxford) the investigators evaluated one such possible tool-Purrble-designed to provide a student-centred, in-the-moment emotion regulation support. Study goals centred on testing usability/usage patterns during 8-week in-situ deployment, perceived usefulness over the same period, and links between use and symptoms in high-anxiety university students (GAD-7 > 10 at sign-up). The results have been promising, with large effects sizes on GAD7 scores over the period of the term (d~0.9), the majority of students perceived the Purrble intervention as useful with 61% reporting in the last survey that it helped their mental health, and detailed a range of positive outcomes in qualitative interviews (e.g., it helped them calm down and ground themselves in the present moment when they are feeling anxious, stressed or lonely, or be more gentle and kind with themselves -rather than harsh and judgmental- when feeling overwhelmed).

However, the open trial pilot study did not include a control or waitlisted group and thus more rigorous investigation of these promising effects is needed - leading to the current study.

Conditions: Anxiety, Emotion Regulation
Being tested: Purrble intervention, Single Session Intervention
Keywords: emotion regulation, in-situ intervention, university students
Medical subject headings: Anxiety Disorders, Emotional Regulation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Purrble interventionBehavioural
The intervention takes the form of an interactive plush toy, designed to be handed over to the child and support in-the-moment soothing.
The Purrble is introduced to the student as an anxious creature that may need kind attention from humans. When picked up, the Purrble emits a frantic heartbeat that slows down if the child uses calm stroking movements. If it's 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 students in emotional moments when they would attempt to practice 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 students' ER practices and implicit beliefs about emotion, after repeated experience of Levels 1-2.
Single Session InterventionBehavioural
Also called SSI
The SSI has been co-produced with university students and clinical experts, combining the theories of ER with the qualitative experiences of students in open trial.
The result follows a traditional SSI structure (cf., Schleider et al 2020), including
- Initial guided reflection exercise (helping understand one's experience with Purrble in the 1st week).
- Short interactive psychoeducation, introducing the concept of window of tolerance, the Process Model of Emotions (Gross2015), and specific ways in which Purrble can help students down-regulate emotions within the context of the process model.
- Action plan to identify: moments when Purrble could be useful, what ER strategies they would like to use in those moments, what obstacles they may encounter, and how to overcome them.
The SSI will be accessible by students on a website and be both desktop and mobile browser friendly. The full process should not take students longer than 30 minutes.

Study groups in NCT05376735
Study group	Role	What they receive
Purrble intervention + Single Session Intervention	Experimental	The Purrble intervention takes the form of an interactive plush toy, designed to be handed over to the child and support in-the-moment soothing. 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. The Single Session Intervention has been co-produced with university students and clinical experts (Prof Jessica Schleider), combining the theories of emotion regulation with the qualitative experiences of students in open trial. The result follows a traditional SSI structure (cf., Schleider et al 2020), including 1. Initial guided reflection exercise 2. Short interactive psychoeducation 3. Personalised action plan The SSI will be accessible by students on a website and be both desktop and mobile browser friendly. The full process should not take students longer than 30 minutes. Receives: Behavioral: Purrble intervention; Behavioral: Single Session Intervention
Treatment as usual / Waiting list	No intervention	Participants in the control group will be given a Purrble \& access to the online SSI intervention before the academic term ends, after 4 week follow-up questionnaires are completed.

What is being measured

The primary outcome is the main question the study is designed to answer.

Anxiety (measured by GAD7) -- pre/mid/post
The primary aim is to investigate the effects of Purrble + SSI intervention on students' changes in anxiety over the period of academic term (in comparison to a wait-listed student group).
Overall changes in anxiety throughout the deployment will be measured by the Generalised Anxiety Disorder Assessment (GAD-7), 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 (Splitzer et al 2006).
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.
Scores of 5, 10, and 15 represent cut-points for mild, moderate, and severe anxiety, respectively. When used as a screening tool, further evaluation is recommended when the score is 10 or greater.
Measured: Three times during the 4-week long deployment period: pre, mid and post deployment
Anxiety (measured by GAD2) -- weekly
The primary aim is to investigate the effects of Purrble + SSI intervention on students' changes in anxiety over the period of academic term (in comparison to a wait-listed student group).
Weekly changes in anxiety will be measured with the Generalized Anxiety Disorder 2-item (GAD-2): a very brief and easy to perform initial screening tool for generalized anxiety disorder. Each item asks the individual to rate the severity of their symptoms over the past two weeks (Kroenke et al 2007). A score of 3 points is the preferred cut-off for identifying possible cases and in which further diagnostic evaluation for generalized anxiety disorder is warranted. Using a cut-off of 3 the GAD-2 has a sensitivity of 86% and specificity of 83% for diagnosis generalized anxiety disorder.
Measured: Once a week for the 4-week long deployment period

Secondary outcomes (10)

Depression -- pre/mid/post
A secondary aim includes investigating the effects of Purrble + SSI intervention on changes in students' depression over the period of academic term (in comparison to a wait-listed student group).
Measured by the PHQ-9: 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: Three times during the 4-week long deployment period: pre, mid and post deployment
Depression -- weekly
We will also track changes in depression on the PHQ-2 (Kroenke et al, 2003) on a weekly basis. This module uses a subset of the PHQ-9 questions ("Little interest or pleasure in doing things", "Feeling down, depressed or hopeless") on the same scoring scale ("0" (not at all) to "3" (nearly every day)).
Measured: Once a week for the 4-week long deployment period
Emotion regulation (beliefs ) -- pre/mid/post
A secondary aim includes investigating the effects of Purrble + SSI intervention on changes in students' emotion regulation processes over the period of academic term (in comparison to a wait-listed student group).
Student-reported beliefs about emotion regulation will be measured by ER beliefs 'questionnaire (Ford et al 2018). Specifically, students will answer 4 questions on a five point likert scale (strongly disagree --> strongly agree): "If I want to, I can change the emotions that I have."; "I can learn to control my feelings."; "No matter how hard I try, I can't really change the emotions that I have."; "The truth is, I have very little control over my emotions."
Measured: Three times during the 4-week long deployment period: pre, mid and post deployment
Emotion regulation (self-efficacy) -- pre/mid/post
A secondary aim includes investigating the effects of Purrble + SSI intervention on changes in students' emotion regulation processes over the period of academic term (in comparison to a wait-listed student group).
Student-reported capability of regulating / managing own emotion will be measured by the self-efficacy version of the Emotion Regulation Questionnaire (ERQ-SE; Goldin 2012).
Measured: Three times during the 4-week long deployment period: pre, mid and post deployment
Engagement with the Purrble intervention - open ended
A secondary aim includes investigating the engagements with the Purrble + SSI intervention over the period of academic term.
Measured by a bespoke survey informed by the pilot study (Dauden Roquet et al 2022). The questions inquire about Purrble use and perceived usefulness. Items are rated on a 0 to 4 scale unless otherwise specified.
1. How often did participants engage with Purrble this week? If not at all, why do participants think that was?
2. On average, did engaging with Purrble make any difference to how participants felt at the time?
3. In what contexts has Purrble been most useful to participants? <open-ended> Have there been any situations in which Purrble has been useful to participants? <open-ended>
4. Have there been any situations participants hoped Purrble could help with, but it didn't really work? <open-ended>
In what contexts has Purrble been least useful to participants? <open-ended>
Measured: Once a week for the 4-week long deployment period
Engagement with the Purrble intervention - TWEETS
A secondary aim includes investigating the engagements with the Purrble + SSI intervention over the period of academic term .
Measured by an adapted version of Twente Engagement with eHealth Technologies Scale (TWEETS; Kelders et al 2020)
Measured: week 2 and week 4 of the active deployment phase
Engagement with the Single Session Intervention
Measured by a program feedback scale (adapted for this study). Items rated on a 0 (really disagree) to 4 (really agree) scale unless otherwise specified.
1. I enjoyed the program
2. I understood the program
3. This program was easy to use
4. I tried my hardest during the program
5. I think the program would be helpful to other university students
6. I would recommend this program to a friend going through a hard time
7. I agree with the program's message
8. What did participants like about the program? Please share as many true thoughts and feelings as participants would like << open-ended, text area >>
9. What would participants change about the program? Please share as many true thoughts and feelings as participants would like << open-ended, text area >>
Measured: Once after completing the online SSI programme (week 1)
Hopefulness -- weekly
A secondary aim includes investigating the effects of Purrble + SSI intervention on changes in students' depression over the period of academic term (in comparison to a wait-listed student group).
Measured by:
--> The State Hope Scale (Snyder et al, 1996) is a 6-item self-report measure of ongoing goal-directed thinking (agency and pathways). Responses are rated on an 8-point Likert scale ranging from 1 (Definitely True) to 8 (Definitely False) with higher scores indicative of greater state hopefulness.
Measured: Once a week for the 4-week long deployment period
Hopelesness -- weekly
A secondary aim includes investigating the effects of Purrble + SSI intervention on changes in students' depression over the period of academic term (in comparison to a wait-listed student group).
Measured by:
--> The Beck Hopelessness Scale (Beck, 1988) provides a self-report measure of one's negative expectations regarding the future. It consists of 20 true-false items arrayed within three factors: Feelings about the future, loss of motivation, and future expectations. The total score is a sum of item responses. Scores ranging from: 0 to 3 within the normal range, 4 to 8 mild hopelessness, 9 to 14 moderate hopelessness, and scores greater than 14 identify severe hopelessness.
Measured: Once a week for the 4-week long deployment period
Emotion regulation -- weekly
A secondary aim includes investigating the effects of Purrble + SSI intervention on changes in students' emotion regulation processes over the period of academic term (in comparison to a wait-listed student group).
We will administer weekly a single item anchoring item measuring the perceived change in their ability to cope with emotions 'this week'. Item is rated on a 0 (much less able) to 4 (a lot more able) scale unless otherwise specified: Since participants' last survey (one week ago), how much have participants felt able to cope with their emotions?
Measured: Once a week for the 4-week long deployment period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 May 202219 Sep 2022

First posted17 May 2022
Study start16 May 2022 (estimated)
Primary completion17 Jul 2022 (estimated)
Study completion19 Sep 2022 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (9)Papers the sponsor has linked to this study.
Other trials for AnxietyStudies 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: Single blind
Who is masked: Participant
Enrolment: 100 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05376735
Sponsor's protocol ID: HR/DP-21/22-28406
Status last verified: Apr 2022
First submitted: 3 May 2022
Last updated: 27 May 2022
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Auerbach RP, Mortier P, Bruffaerts R, Alonso J, Benjet C, Cuijpers P, Demyttenaere K, Ebert DD, Green JG, Hasking P, Murray E, Nock MK, Pinder-Amaker S, Sampson NA, Stein DJ, Vilagut G, Zaslavsky AM, Kessler RC; WHO WMH-ICS Collaborators. WHO World Mental Health Surveys International College Student Project: Prevalence and distribution of mental disorders. J Abnorm Psychol. 2018 Oct;127(7):623-638. doi: 10.1037/abn0000362. Epub 2018 Sep 13.
PubMed 30211576
Torous J, Nicholas J, Larsen ME, Firth J, Christensen H. Clinical review of user engagement with mental health smartphone apps: evidence, theory and improvements. Evid Based Ment Health. 2018 Aug;21(3):116-119. doi: 10.1136/eb-2018-102891. Epub 2018 Jun 5.
PubMed 29871870
Brown JSL. Student mental health: some answers and more questions. J Ment Health. 2018 Jun;27(3):193-196. doi: 10.1080/09638237.2018.1470319. Epub 2018 May 16. No abstract available.
PubMed 29768071
Musiat P, Goldstone P, Tarrier N. Understanding the acceptability of e-mental health--attitudes and expectations towards computerised self-help treatments for mental health problems. BMC Psychiatry. 2014 Apr 11;14:109. doi: 10.1186/1471-244X-14-109.
PubMed 24725765
Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
PubMed 16717171
Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
PubMed 11556941
Goldin PR, Ziv M, Jazaieri H, Werner K, Kraemer H, Heimberg RG, Gross JJ. Cognitive reappraisal self-efficacy mediates the effects of individual cognitive-behavioral therapy for social anxiety disorder. J Consult Clin Psychol. 2012 Dec;80(6):1034-40. doi: 10.1037/a0028555. Epub 2012 May 14.
PubMed 22582765
Ford BQ, Lwi SJ, Gentzler AL, Hankin B, Mauss IB. The cost of believing emotions are uncontrollable: Youths' beliefs about emotion predict emotion regulation and depressive symptoms. J Exp Psychol Gen. 2018 Aug;147(8):1170-1190. doi: 10.1037/xge0000396. Epub 2018 Apr 5.
PubMed 29620380
Kelders SM, Kip H, Greeff J. Psychometric Evaluation of the TWente Engagement with Ehealth Technologies Scale (TWEETS): Evaluation Study. J Med Internet Res. 2020 Oct 9;22(10):e17757. doi: 10.2196/17757.
PubMed 33021487

Want to know more?

Petr Slovak, Dr

+44 020 7848 1988

petr.slovak@kcl.ac.uk

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Anxiety trials

Study at a glance

From the registry record, last updated by the sponsor on 27 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Exploratory Randomised Control Trial of a Single Session Intervention Combined With In-situ Socially Assistive Robot to Promote Emotion Regulation Competence in University Students
ClinicalTrials.gov ID: NCT05376735
Acronym / sponsor ID: HR/DP-21/22-28406
Conditions: Anxiety, Emotion Regulation
Keywords: emotion regulation, in-situ intervention, university students
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 100 participants (estimated)
Lead sponsor: King's College LondonUniversity, hospital or other
Collaborators: University of Oxford, Stony Brook University, Stanford University
Study start: 16 May 2022 (estimated)
Primary completion: 17 Jul 2022 (estimated)
Study completion: 19 Sep 2022 (estimated)
First posted: 17 May 2022 (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.

Detailed description

However, the open trial pilot study did not include a control or waitlisted 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: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Purrble intervention + Single Session Intervention	Experimental	Behavioral: Purrble intervention, Behavioral: Single Session InterventionThe Purrble intervention takes the form of an interactive plush toy, designed to be handed over to the child and support in-the-moment soothing. 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. The Single Session Intervention has been co-produced with university students and clinical experts (Prof Jessica Schleider), combining the theories of emotion regulation with the qualitative experiences of students in open trial. The result follows a traditional SSI structure (cf., Schleider et al 2020), including 1. Initial guided reflection exercise 2. Short interactive psychoeducation 3. Personalised action plan The SSI will be accessible by students on a website and be both desktop and mobile browser friendly. The full process should not take students longer than 30 minutes.
Treatment as usual / Waiting list	No intervention	–Participants in the control group will be given a Purrble \& access to the online SSI intervention before the academic term ends, after 4 week follow-up questionnaires are completed.

Who may qualify

Ages: 18 to 25 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Currently registered as a student at Oxford University (under- or postgraduate) at the time of the study
Currently living in the UK at the time of the study
Aged 18-25
GAD7 score >= 10 (Löwe, 2008)
Consistent internet and computer/laptop/smartphone access

Key exclusion criteria (3 listed)

Not an Oxford University student currently living in the UK at the time of the study
Not within age range
GAD7 score < 10 (Löwe, 2008)

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 interventionThe intervention takes the form of an interactive plush toy, designed to be handed over to the child and support in-the-moment soothing. The Purrble is introduced to the student as an anxious creature that may need kind attention from humans. When picked up, the Purrble emits a frantic heartbeat that slows down if the child uses calm stroking movements. If it's 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 students in emotional moments when they would attempt to practice 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 students' ER practices and implicit beliefs about emotion, after repeated experience of Levels 1-2.	Behavioural	Purrble intervention + Single Session Intervention
Single Session InterventionAlso: SSIThe SSI has been co-produced with university students and clinical experts, combining the theories of ER with the qualitative experiences of students in open trial. The result follows a traditional SSI structure (cf., Schleider et al 2020), including * Initial guided reflection exercise (helping understand one's experience with Purrble in the 1st week). * Short interactive psychoeducation, introducing the concept of window of tolerance, the Process Model of Emotions (Gross2015), and specific ways in which Purrble can help students down-regulate emotions within the context of the process model. * Action plan to identify: moments when Purrble could be useful, what ER strategies they would like to use in those moments, what obstacles they may encounter, and how to overcome them. The SSI will be accessible by students on a website and be both desktop and mobile browser friendly. The full process should not take students longer than 30 minutes.	Behavioural	Purrble intervention + Single Session Intervention

Primary outcome

Anxiety (measured by GAD7) -- pre/mid/post
Time frame: Three times during the 4-week long deployment period: pre, mid and post deployment
The primary aim is to investigate the effects of Purrble + SSI intervention on students' changes in anxiety over the period of academic term (in comparison to a wait-listed student group). Overall changes in anxiety throughout the deployment will be measured by the Generalised Anxiety Disorder Assessment (GAD-7), 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 (Splitzer et al 2006). 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. Scores of 5, 10, and 15 represent cut-points for mild, moderate, and severe anxiety, respectively. When used as a screening tool, further evaluation is recommended when the score is 10 or greater.
Anxiety (measured by GAD2) -- weekly
Time frame: Once a week for the 4-week long deployment period
The primary aim is to investigate the effects of Purrble + SSI intervention on students' changes in anxiety over the period of academic term (in comparison to a wait-listed student group). Weekly changes in anxiety will be measured with the Generalized Anxiety Disorder 2-item (GAD-2): a very brief and easy to perform initial screening tool for generalized anxiety disorder. Each item asks the individual to rate the severity of their symptoms over the past two weeks (Kroenke et al 2007). A score of 3 points is the preferred cut-off for identifying possible cases and in which further diagnostic evaluation for generalized anxiety disorder is warranted. Using a cut-off of 3 the GAD-2 has a sensitivity of 86% and specificity of 83% for diagnosis generalized anxiety disorder.

10 secondary outcomes

Depression -- pre/mid/post
Time frame: Three times during the 4-week long deployment period: pre, mid and post deployment
Depression -- weekly
Time frame: Once a week for the 4-week long deployment period
Emotion regulation (beliefs ) -- pre/mid/post
Time frame: Three times during the 4-week long deployment period: pre, mid and post deployment
Emotion regulation (self-efficacy) -- pre/mid/post
Time frame: Three times during the 4-week long deployment period: pre, mid and post deployment
Engagement with the Purrble intervention - open ended
Time frame: Once a week for the 4-week long deployment period
Engagement with the Purrble intervention - TWEETS
Time frame: week 2 and week 4 of the active deployment phase
Engagement with the Single Session Intervention
Time frame: Once after completing the online SSI programme (week 1)
Hopefulness -- weekly
Time frame: Once a week for the 4-week long deployment period
Hopelesness -- weekly
Time frame: Once a week for the 4-week long deployment period
Emotion regulation -- weekly
Time frame: Once a week for the 4-week long deployment period

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2022.
Background: PubMed 30211576Auerbach RP, Mortier P, Bruffaerts R, Alonso J, Benjet C, Cuijpers P, Demyttenaere K, Ebert DD, Green JG, Hasking P, Murray E, Nock MK, Pinder-Amaker S, Sampson NA, Stein DJ, Vilagut G, Zaslavsky AM, Kessler RC; WHO WMH-ICS Collaborators. WHO World Mental Health Surveys International College Student Project: Prevalence and distribution of mental disorders. J Abnorm Psychol. 2018 Oct;127(7):623-638. doi: 10.1037/abn0000362. Epub 2018 Sep 13.
Background: PubMed 29871870Torous J, Nicholas J, Larsen ME, Firth J, Christensen H. Clinical review of user engagement with mental health smartphone apps: evidence, theory and improvements. Evid Based Ment Health. 2018 Aug;21(3):116-119. doi: 10.1136/eb-2018-102891. Epub 2018 Jun 5.
Background: PubMed 29768071Brown JSL. Student mental health: some answers and more questions. J Ment Health. 2018 Jun;27(3):193-196. doi: 10.1080/09638237.2018.1470319. Epub 2018 May 16. No abstract available.
Background: PubMed 24725765Musiat P, Goldstone P, Tarrier N. Understanding the acceptability of e-mental health--attitudes and expectations towards computerised self-help treatments for mental health problems. BMC Psychiatry. 2014 Apr 11;14:109. doi: 10.1186/1471-244X-14-109.
Background: PubMed 16717171Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
Background: PubMed 11556941Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
Background: PubMed 22582765Goldin PR, Ziv M, Jazaieri H, Werner K, Kraemer H, Heimberg RG, Gross JJ. Cognitive reappraisal self-efficacy mediates the effects of individual cognitive-behavioral therapy for social anxiety disorder. J Consult Clin Psychol. 2012 Dec;80(6):1034-40. doi: 10.1037/a0028555. Epub 2012 May 14.
Background: PubMed 29620380Ford BQ, Lwi SJ, Gentzler AL, Hankin B, Mauss IB. The cost of believing emotions are uncontrollable: Youths' beliefs about emotion predict emotion regulation and depressive symptoms. J Exp Psychol Gen. 2018 Aug;147(8):1170-1190. doi: 10.1037/xge0000396. Epub 2018 Apr 5.
Background: PubMed 33021487Kelders SM, Kip H, Greeff J. Psychometric Evaluation of the TWente Engagement with Ehealth Technologies Scale (TWEETS): Evaluation Study. J Med Internet Res. 2020 Oct 9;22(10):e17757. doi: 10.2196/17757.
Individual participant dataSharing planned: No

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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.

Petr Slovak, Dr contact

+44 020 7848 1988

petr.slovak@kcl.ac.uk

Questions about this trial

What is this clinical trial studying?

A study testing Purrble intervention and Single Session Intervention in people with Anxiety and Emotion Regulation, run by King's College London.

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 6 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 27 May 2022. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Petr Slovak, Dr (+44 020 7848 1988, petr.slovak@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Anxiety (measured by GAD7) -- pre/mid/post (time frame: Three times during the 4-week long deployment period: pre, mid and post deployment). The study lists 2 primary outcomes in all. 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 NCT05376735, which also lists 9 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 27 May 2022.