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

How do You Feelee? Does an Ordinary Question a Day Supports Youth in a Forensic Outpatient Setting to Become More Emotional Balanced? A Multiple Case Experimental Design

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.

Study Overview

• Status: Recruiting
• Conditions: Emotion Regulation; Emotional Neglect
• Intervention / Treatment: Device: Feelee app

Detailed Description

Participants will be subjected to a ABA baseline design: including a 2-weeks baseline phase (A), 4-weeks intervention phase (B) and 2-weeks follow-up phase.

During the baseline phase (A), participants will fill in a daily questionnaire that measures different aspects of their emotion regulation skills. The use of the Feelee app is not allowed yet. After 2-weeks, the intervention phase starts, meaning participants will use the Feelee app every day during a 4-weeks period. The use of the Feelee app includes specifying an emoji and collecting the passive data on the background. Furthermore, the collected active and passive data will be discussed through the clinicians during the participants weekly treatment sessions. Participants will also be continuing to complete the daily questionnaire. After 4-weeks, the follow-up phase starts. Participants need to remove the Feelee app and will follow their treatment as usual. However, participants still need to complete the daily questionnaire. After 2-weeks the follow-up phase and main study part has ended.

Throughout the ABA baseline, pre-measurement (T0), post-measurement (T1) follow-up measurement (Tf1) will be conducted before and after the intervention and during follow-up. Last, a 3-months follow-up will be conducted to identify possible long-term effects.

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Merel Leijse, Msc; Phone Number: +31 6 40043394; Email: m.m.l.leijse@amsterdamumc.nl

Study Locations

• Netherlands
  • Noord-Holland
    • Amsterdam, Noord-Holland, Netherlands, 1058 AA
      • Recruiting
      • Inforsa
      • Contact: Thimo van der Pol, dr.
    • Amsterdam, Noord-Holland, Netherlands, 1076 EC
      • Recruiting
      • LEVVEL
      • Contact: René Breuk, dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Feelee app; 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; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Emotional differentiation: Positive and Negative Affect Schedule (PANAS)	Emotional differentiation includes the ability to recognize and distinct different emotional expressions. Participants will be asked to rate the extent they experienced one of the 20 items that describes different emotions. The instruments consist of 2 subscales: positive affect and negative affect. These concepts will be scored on a 5-point Likert scale, using the following options: 1 = 'Very slightly/not at all', 2 = 'A little', 3 = 'Moderately', 4 = 'Quite a bit' and 5 = 'Extremely'.	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)	Self-reflection involves the process of looking back at experiences, emotions and behavior in order help individuals to clarify a meaning to it and gain more self-awareness. The SRIS-Y is a 17-item self-report questionnaire, answered with a 6-point Likert scale ranging from 1 = 'disagree strongly' to 6= 'agree strongly'. The instrument consists of two subscales self-reflection and and insight resulting in two separate scores. A higher score represents a higher degree of self-reflection and self-insight.	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)	Emotional awareness involves a subjective understanding of the emotional states and ability to recognize possible causes underlying the emotional states. In this study, only the emotional awareness subscale of the MAIA will be used. Answers can be given on a 6-point Likert scale ranging from 0 = 'never' to 5 = 'always'. Scores of the subscale can easily been calculating the total score and dividing it by the number of items belonging to the subscale. A higher score represents a higher degree of emotional awareness.	Pre-measurement (T0) at Week 1, post-measurement (T1) at Week 6 and follow-up-measurement at Week 8.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Motivation for treatment: Dutch Adolescent Treatment Motivation Questionnaire (ATMQ)	Motivation for treatment includes the engagement for treatment engagement and willingness to change behavior. The ATMQ consists of 11 self-report items with a 3-point Likert scale including 'not true', 'kind of true' and 'true'. The total score is calculated using the average of the number of items. A higher score represents a higher degree of motivation for treatment.	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)	Treatment alliance involves the working relationship between client and clinician. The WAV-12 questionnaire contains a youth, parental, mentor and family therapist version. In this study only the youth version will be used. The WAV-12 consist of 12 self-report items with a 5-point Likert scale: 1 = 'rarely or never', 2 = 'sometimes', 3 = 'regularly', 4 = 'very often' and 5 = 'always'. Higher scores on this questionnaire indicate a good working alliance between client and clinical.	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)	Evaluation of the smartphone usage in treatment involves the participants experience regarding the usage of the Feelee app in addition to treatment. The TWEETS-scale consist of 9 items about engagement of which 3 assess behavioral engagement, 3 cognitive engagement and 3 affective engagement. Answers can be given on a 5-point Likert scale: 0 = 'strongly disagree', 1 = 'disagree', 2 = 'neutral', 3 = 'agree' and 4 = 'strongly agree'	Follow-up measurement (Tf1) at Week 8 and 3 months follow-up measurement (Tf2) at Week 21 (3 months after Tf1)
Evaluation usability Feelee app: The System Usability Scale (SUS)	Evaluation of the usability of the Feelee app involves the evaluation regarding the user experience (e.g. user interface and design of the app) from participants perspectives. The SUS-scale is quick tool to measure usability by 10 items. Answers can be given on a 5-point Likert scale: 0 = 'strongly disagree', 1 = 'disagree', 2 = 'neutral', 3 = 'agree' and 4 = 'strongly agree'.	Follow-up measurement (Tf1) at Week 8 and 3 months follow-up measurement (Tf2) at Week 21 (3 months after Tf1)

Collaborators and Investigators

• Sponsor: Amsterdam UMC, location VUmc
• Collaborators: Arkin; Levvel; KFZ-J
• Investigators: Principal Investigator: Arne Popma, Prof. dr., Amsterdam UMC, location VUmc

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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
• 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
• 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.
• 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
• 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.

Helpful Links

• Website Feelee app

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2023
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: September 1, 2023
• First Submitted That Met QC Criteria: July 12, 2024
• First Posted (Actual): July 19, 2024

Study Record Updates

• Last Update Posted (Actual): July 19, 2024
• Last Update Submitted That Met QC Criteria: July 12, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Adolescents; Emotion regulation; Smartphone data; Emoji; Forensic outpatient care
• Other Study ID Numbers: NL78889.029.22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Study Data/Documents

1. Individual Participant Data Set
   Information comments: Individual participant data is collected anonymously in Castor EDC.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No