How do You Feelee? Emotion-based Smartphone App in the Forensic Outpatient Setting
NCT Number: NCT06509360
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Emotion Regulation|Emotional Neglect
Interventions: DEVICE: Feelee app
Sponsor: Amsterdam UMC, location VUmc
Collaborators: Levvel|Arkin|KFZ-J
Sex: ALL
Age: CHILD, ADULT
Enrollment: 24
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2023-08-03
Completion Date: 2024-12
Locations: Inforsa, Amsterdam, Noord-Holland, 1058 AA, Netherlands|Levvel, Amsterdam, Noord-Holland, 1076 EC, Netherlands

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.

Primary Outcome Measures: 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: 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: 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)