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NCT Number: NCT06509360

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

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.

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Key information

Age range

12 year–23 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Inforsa, Amsterdam, North Holland, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

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)

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

    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.

Secondary outcomes

  1. Emotional differentiation: Positive and Negative Affect Schedule (PANAS)

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

    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'.

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

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

    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.

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

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

    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.

Other outcomes

  1. Motivation for treatment: Dutch Adolescent Treatment Motivation Questionnaire (ATMQ)

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

    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.

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

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

    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.

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

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

    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'

  4. Evaluation usability Feelee app: The System Usability Scale (SUS)

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

    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'.

Study contacts

Contact information is provided by the study sponsor or research team.

Merel Leijse, Msc

CONTACT

[email protected]

+31 6 40043394

Sponsors and collaborators

Lead sponsor

Amsterdam UMC, location VUmc

Other

Collaborators

  • Arkin
  • KFZ-J
  • Levvel

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 19, 2024
Registry last updated
Jul 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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