Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2026-02-21 @ 6:45 PM
Study NCT ID:
NCT06509360
Status:
RECRUITING
Last Update Posted:
2024-07-19
First Post:
2023-09-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
How do You Feelee? Emotion-based Smartphone App in the Forensic Outpatient Setting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000080103', 'term': 'Emotional Regulation'}], 'ancestors': [{'id': 'D000068356', 'term': 'Self-Control'}, {'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single Case Experimental Design'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-08-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-12', 'studyFirstSubmitDate': '2023-09-01', 'studyFirstSubmitQcDate': '2024-07-12', 'lastUpdatePostDateStruct': {'date': '2024-07-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Motivation for treatment: Dutch Adolescent Treatment Motivation Questionnaire (ATMQ)', 'timeFrame': 'Pre-measurement (T0) at Week 1, post-measurement (T1) at Week 6 and follow-up-measurement at Week 8.', 'description': "Motivation for treatment includes the engagement for treatment engagement and willingness to change behavior.\n\nThe 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."}, {'measure': 'Treatment alliance: Dutch translation of the Working Alliance Inventory (WAV-12)', 'timeFrame': 'Pre-measurement (T0) at Week 1, post-measurement (T1) at Week 6 and follow-up-measurement at Week 8.', 'description': "Treatment alliance involves the working relationship between client and clinician.\n\nThe 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."}, {'measure': 'Evaluation smartphone usage in treatment: the TWente Engagement with E-health Technologies Scales (TWEETS)', 'timeFrame': 'Follow-up measurement (Tf1) at Week 8 and 3 months follow-up measurement (Tf2) at Week 21 (3 months after Tf1)', 'description': "Evaluation of the smartphone usage in treatment involves the participants experience regarding the usage of the Feelee app in addition to treatment.\n\nThe 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'"}, {'measure': 'Evaluation usability Feelee app: The System Usability Scale (SUS)', 'timeFrame': 'Follow-up measurement (Tf1) at Week 8 and 3 months follow-up measurement (Tf2) at Week 21 (3 months after Tf1)', 'description': "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.\n\nThe 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'."}], 'primaryOutcomes': [{'measure': '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)', 'timeFrame': 'Daily questionnaire (24 hour interval). From Day 0 (Week 1) up to Day 56 (Week 8).', 'description': 'Emotion regulation involves the ability to recognize, comprehends and manage emotions.\n\nThe 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).\n\nThe 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.'}], 'secondaryOutcomes': [{'measure': 'Emotional differentiation: Positive and Negative Affect Schedule (PANAS)', 'timeFrame': 'Pre-measurement (T0) at Week 1, post-measurement (T1) at Week 6 and follow-up-measurement at Week 8', 'description': "Emotional differentiation includes the ability to recognize and distinct different emotional expressions.\n\nParticipants 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'."}, {'measure': 'Self-reflection: Self-Reflection and Insight Scale for Youth (SRIS-Y)', 'timeFrame': 'Pre-measurement (T0) at Week 1, post-measurement (T1) at Week 6 and follow-up-measurement at Week 8.', 'description': "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.\n\nThe 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."}, {'measure': 'Emotional awareness: Emotional awareness subscale of the Multidimensional Assessment of Interoceptive Awareness (MAIA)', 'timeFrame': 'Pre-measurement (T0) at Week 1, post-measurement (T1) at Week 6 and follow-up-measurement at Week 8.', 'description': "Emotional awareness involves a subjective understanding of the emotional states and ability to recognize possible causes underlying the emotional states.\n\nIn 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."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Smartphone data', 'Emoji', 'Emotion regulation', 'Adolescents', 'Forensic outpatient care'], 'conditions': ['Emotion Regulation', 'Emotional Neglect']}, 'referencesModule': {'availIpds': [{'url': 'https://www.castoredc.com/', 'type': 'Individual Participant Data Set', 'comment': 'Individual participant data is collected anonymously in Castor EDC.'}], 'references': [{'pmid': '31507464', 'type': 'BACKGROUND', 'citation': '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': '29253607', 'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': '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'}, {'type': 'BACKGROUND', 'citation': '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'}, {'pmid': '3397865', 'type': 'BACKGROUND', 'citation': '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': '20380777', 'type': 'BACKGROUND', 'citation': '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': '23133619', 'type': 'BACKGROUND', 'citation': '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': '22627687', 'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': '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'}, {'pmid': '33021487', 'type': 'BACKGROUND', 'citation': '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': '36573399', 'type': 'BACKGROUND', 'citation': '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': '40601926', 'type': 'DERIVED', 'citation': "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."}], 'seeAlsoLinks': [{'url': 'https://www.feelee.nl/en/home', 'label': 'Website Feelee app'}]}, 'descriptionModule': {'briefSummary': "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.\n\nParticipants 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.", 'detailedDescription': '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.\n\nDuring 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.\n\nThroughout 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '23 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At the time of the study in treatment at a forensic outreach youth care organization.\n* Expected to be in treatment for at least another 3 months.\n* Using a smartphone with Android or IOS operating system.\n* Have basic understanding about the use of a smartphone\n\nExclusion Criteria:\n\n* Adolescents with serious psychiatric problems, such as psychosis or high risk of suicide\n* Insufficient understanding of spoken and written Dutch language.\n* Adolescents without a smartphone.'}, 'identificationModule': {'nctId': 'NCT06509360', 'briefTitle': 'How do You Feelee? Emotion-based Smartphone App in the Forensic Outpatient Setting', 'organization': {'class': 'OTHER', 'fullName': 'Amsterdam UMC, location VUmc'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'NL78889.029.22'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Feelee app', 'description': '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).', 'interventionNames': ['Device: Feelee app']}], 'interventions': [{'name': 'Feelee app', 'type': 'DEVICE', 'description': '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).', 'armGroupLabels': ['Feelee app']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1058 AA', 'city': 'Amsterdam', 'state': 'North Holland', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Thimo van der Pol, dr.', 'role': 'CONTACT'}], 'facility': 'Inforsa', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '1076 EC', 'city': 'Amsterdam', 'state': 'North Holland', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'René Breuk, dr.', 'role': 'CONTACT'}], 'facility': 'Levvel', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}], 'centralContacts': [{'name': 'Merel Leijse, Msc', 'role': 'CONTACT', 'email': 'm.m.l.leijse@amsterdamumc.nl', 'phone': '+31 6 40043394'}], 'overallOfficials': [{'name': 'Arne Popma, Prof. dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Amsterdam UMC, location VUmc'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amsterdam UMC, location VUmc', 'class': 'OTHER'}, 'collaborators': [{'name': 'Levvel', 'class': 'UNKNOWN'}, {'name': 'Arkin', 'class': 'INDUSTRY'}, {'name': 'KFZ-J', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. dr.', 'investigatorFullName': 'Prof. dr. Arne Popma', 'investigatorAffiliation': 'Amsterdam UMC, location VUmc'}}}}