How do You Feelee? Emotion-based Smartphone App in the Forensic Outpatient Setting

NCT06509360 | Recruiting DMC

• 1 other identifier: NL78889.029.22
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

Brief Summary

This intervention study aims to explore the addition of the Feelee app (using active emoji data with passive behavioral data through phone sensing) in treatment as usual for adolescents in the forensic outpatient setting. Participants will use Feelee for 4 weeks, which means specifying an emoji each day and collecting the passive data on the background. The collected active and passive data will be discussed through the clinicians during the participants' weekly treatment sessions.

Conditions

Emotion Regulation; Emotional Neglect

Keywords

Smartphone data; Emoji; Emotion regulation; Adolescents; Forensic outpatient care

Outcome Measures

Primary Outcomes (1)

• Emotion regulation: measured by a composite of items from the Difficulties in Emotional Dysregulation Scale (DERS-36) and Regulation of Emotion Systems Survey for daily usage (RESS-EMA)

  Emotion regulation involves the ability to recognize, comprehends and manage emotions. The first 2 items are from the DERS-36 scale and measure construct recognize (clarity) and manage (impulse) of emotion regulation. Answers on these scales can be given on a 5-point Likert-scale (0= almost never too 5= almost always). The other 4 items are from the RESS-EMA survey The RESS-EMA questionnaire consists of different aspects of the emotion regulation systems and strategies that are suitable for daily usage. The items included in the daily questionnaire are: comprehends (rumination), comprehends (reappraisal), manage (distraction) and manage (suppression). Answers can be given from 0 = not at all to 10 = very much.

  Daily questionnaire (24 hour interval). From Day 0 (Week 1) up to Day 56 (Week 8).

Secondary Outcomes (3)

• Emotional differentiation: Positive and Negative Affect Schedule (PANAS)

  Pre-measurement (T0) at Week 1, post-measurement (T1) at Week 6 and follow-up-measurement at Week 8

• Self-reflection: Self-Reflection and Insight Scale for Youth (SRIS-Y)

  Pre-measurement (T0) at Week 1, post-measurement (T1) at Week 6 and follow-up-measurement at Week 8.

• Emotional awareness: Emotional awareness subscale of the Multidimensional Assessment of Interoceptive Awareness (MAIA)

  Pre-measurement (T0) at Week 1, post-measurement (T1) at Week 6 and follow-up-measurement at Week 8.

Other Outcomes (4)

• Motivation for treatment: Dutch Adolescent Treatment Motivation Questionnaire (ATMQ)

  Pre-measurement (T0) at Week 1, post-measurement (T1) at Week 6 and follow-up-measurement at Week 8.

• Treatment alliance: Dutch translation of the Working Alliance Inventory (WAV-12)

  Pre-measurement (T0) at Week 1, post-measurement (T1) at Week 6 and follow-up-measurement at Week 8.

• Evaluation smartphone usage in treatment: the TWente Engagement with E-health Technologies Scales (TWEETS)

  Follow-up measurement (Tf1) at Week 8 and 3 months follow-up measurement (Tf2) at Week 21 (3 months after Tf1)

Study Arms (1)

Feelee app

OTHER

Following a Single Case Experimental Design, all participants will follow a ABA baseline: 2-weeks baseline phase without intervention (A), 4-weeks intervention phase using the Feelee app (B) and a 2-weeks follow-up phase without intervention again (B).

Device: Feelee app

Interventions

Feelee app DEVICE

Adolescents uses the Feelee app for 4-weeks in addition to treatment as usual in the forensic outpatient setting. The use of Feelee involves: submitting one emoji every day and allow the Feelee app to read the following passive data from the health app on the smartphone: number of steps and number of hours of sleep. The collected Feelee data will be presented in a dashboard in the Feelee app itself which will be discussed by the clinician in the weekly treatment session (in case the adolescents agreed to show the Feelee data to the clinician).

Feelee app

Eligibility Criteria

• Age: 12 Years - 23 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• At the time of the study in treatment at a forensic outreach youth care organization.
• Expected to be in treatment for at least another 3 months.
• Using a smartphone with Android or IOS operating system.
• Have basic understanding about the use of a smartphone

You may not qualify if:

• Adolescents with serious psychiatric problems, such as psychosis or high risk of suicide
• Insufficient understanding of spoken and written Dutch language.
• Adolescents without a smartphone.

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead
• Levvel: collaborator
• Arkin: collaborator
• KFZ-J: collaborator

Study Sites (2)

Inforsa

Amsterdam, North Holland, 1058 AA, Netherlands

RECRUITING

Levvel

Amsterdam, North Holland, 1076 EC, Netherlands

RECRUITING

Related Publications (12)

• Van Dam L, Rietstra S, Van der Drift E, Stams GJJM, Van der Mei R, Mahfoud M, Popma A, Schlossberg E, Pentland A, Reid TG. Can an Emoji a Day Keep the Doctor Away? An Explorative Mixed-Methods Feasibility Study to Develop a Self-Help App for Youth With Mental Health Problems. Front Psychiatry. 2019 Aug 23;10:593. doi: 10.3389/fpsyt.2019.00593. eCollection 2019.

  PMID: 31507464 BACKGROUND

• Krasny-Pacini A, Evans J. Single-case experimental designs to assess intervention effectiveness in rehabilitation: A practical guide. Ann Phys Rehabil Med. 2018 May;61(3):164-179. doi: 10.1016/j.rehab.2017.12.002. Epub 2017 Dec 15.

  PMID: 29253607 BACKGROUND

• Victor SE, Klonsky ED. Validation of a Brief Version of the Difficulties in Emotion Regulation Scale (DERS-18) in Five Samples. Journal Psychopathologic behavior Assess. 2016; 38(4): 582-589. doi: 10.1007/s10862-016-9547-9

  BACKGROUND

• Medland H, De France K, Hollenstein T, Mussoff D, Koval P. Regulating emotion systems in everyday life: Reliability and validity of the RESS-EMA scale. European Journal of Psychological Assessment. 2020; 36(3): 437-446. doi:10.1027/1015-5759/a000595

  BACKGROUND

• Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.

  PMID: 3397865 BACKGROUND

• Sauter FM, Heyne D, Blote AW, van Widenfelt BM, Westenberg PM. Assessing therapy-relevant cognitive capacities in young people: development and psychometric evaluation of the self-reflection and insight scale for youth. Behav Cogn Psychother. 2010 May;38(3):303-17. doi: 10.1017/S1352465810000020. Epub 2010 Apr 12.

  PMID: 20380777 BACKGROUND

• Mehling WE, Price C, Daubenmier JJ, Acree M, Bartmess E, Stewart A. The Multidimensional Assessment of Interoceptive Awareness (MAIA). PLoS One. 2012;7(11):e48230. doi: 10.1371/journal.pone.0048230. Epub 2012 Nov 1.

  PMID: 23133619 BACKGROUND

• Van der Helm GH, Wissink IB, De Jongh T, Stams GJ. Measuring treatment motivation in secure juvenile facilities. Int J Offender Ther Comp Criminol. 2013 Aug;57(8):996-1008. doi: 10.1177/0306624X12443798. Epub 2012 May 23.

  PMID: 22627687 BACKGROUND

• Horvath AO, Greenberg LS. Development and validation of the Working Alliance Inventory. Journal of Counseling Psychology. 1989; 36(2): 223-233. https://doi.org/10.1037/0022-0167.36.2.223

  BACKGROUND

• 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.

  PMID: 33021487 BACKGROUND

• Ensink CJ, Keijsers NLW, Groen BE. Translation and validation of the System Usability Scale to a Dutch version: D-SUS. Disabil Rehabil. 2024 Jan;46(2):395-400. doi: 10.1080/09638288.2022.2160837. Epub 2022 Dec 27.

  PMID: 36573399 BACKGROUND

• Leijse MML, van Dam L, van der Pol TM, Breuk R, Popma A. The Effects of a Smartphone App (Feelee) to Enhance Adolescents' Emotion Regulation Skills in a Forensic Outpatient Setting: Protocol for a Multiple Single-Case Experimental Design. JMIR Res Protoc. 2025 Jul 2;14:e64756. doi: 10.2196/64756.

  PMID: 40601926 DERIVED

Related Links

• Website Feelee app

MeSH Terms

Conditions

Emotional Regulation

Condition Hierarchy (Ancestors)

Self-Control; Social Behavior; Behavior

Study Officials

• Arne Popma, Prof. dr.

  Amsterdam UMC, location VUmc

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Merel Leijse, Msc

CONTACT

+31 6 40043394; m.m.l.leijse@amsterdamumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr.

Model Details: Single Case Experimental Design

Study Record Dates

• First Submitted: September 1, 2023
• First Posted: July 19, 2024
• Study Start: August 3, 2023
• Primary Completion: September 1, 2024
• Study Completion: December 1, 2024
• Last Updated: July 19, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (2)