FlexED: Eine digitale, spielerische Frühintervention bei Essstörungen
The goal of this clinical trial is to test a new intervention for body-image distress to reduce eating disorder symptoms in young women and girls between the ages of 15-25 years old.
Participants complete up to 8 digital sessions using their mobile phone that include a character, story line and interactive exercises, games and digital rewards. Everyone in the study completes the intervention after different periods of time (2, 4 or 6 weeks) of completing assessments.
Researchers will examine the impact of the intervention on participants ability to respond flexibly to body-image distress or triggers, measuring things like heart rate, eye gaze, and reaction time to body-image related words and images, and test how long it takes to see change.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
This multiple baseline experiment tests the impact of a digital, gamified early intervention for eating disorders on body-image psychological flexibility and assesses treatment dose. Twenty-four young women and girls with eating disorder (ED) symptoms are randomized to baseline duration between 2-6 weeks. Participants complete up to eight 20-30 minute sessions of a multimedia application using their mobile phone. Psychological flexibility is measured repeatedly using a multi-level, multi-dimensional assessment strategy of self-report and lab-based tasks assessing flexibility in cognition, affect and attention with body-image related stimuli during the baseline and treatment phases to estimate treatment effects.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
North Carolina
-
Durham, North Carolina, Vereinigte Staaten, 27705
- Duke University
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Female identified 15-25 years old
- Weight Concerns Scale score of >47
- Eating disorder behaviors with onset at current level <3 years
Exclusion Criteria:
- Currently meet diagnostic criteria for anorexia or bulimia nervosa
- Psychosis, substance use disorder or current suicidal ideation or self-harm.
- Start or change in psychiatric medications within the past month.
- NonEnglish Speaking.
- Presents with other specified feeding or eating disorder (OSFED) that does not includes weight/shape concerns as a primary feature (e.g., Avoidant Restrictive Food Intake Disorder).
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 2-Week Baseline Duration
2 weeks of assessment, then 8 weeks of intervention |
Intervention consists of eight 20-30 minute sessions of a digital intervention based on Acceptance and Commitment Therapy (ACT). Participants learn skills of body image flexibility by following an avatar through a story line and completing interactive exercises. |
|
Experimental: 4-Week Baseline Duration
4 weeks of assessment, then 8 weeks of intervention |
Intervention consists of eight 20-30 minute sessions of a digital intervention based on Acceptance and Commitment Therapy (ACT). Participants learn skills of body image flexibility by following an avatar through a story line and completing interactive exercises. |
|
Experimental: 6-Week Baseline Duration
6 weeks of assessment, then 8 weeks of intervention |
Intervention consists of eight 20-30 minute sessions of a digital intervention based on Acceptance and Commitment Therapy (ACT). Participants learn skills of body image flexibility by following an avatar through a story line and completing interactive exercises. |
|
Experimental: Condensed schedule
2 weeks of assessment, then 4 weeks of intervention (sessions twice a week) |
Intervention consists of eight 20-30 minute sessions of a digital intervention based on Acceptance and Commitment Therapy (ACT). Participants learn skills of body image flexibility by following an avatar through a story line and completing interactive exercises. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in Body Image - Acceptance and Action Questionnaire-5 (BI-AAQ-5)
Zeitfenster: Baseline, 6-8 weeks and 12 weeks
|
5-item measure assessing the ability to behave flexibly in the presence of negative thoughts and feelings about the body. Scores range from 5 to 35 with higher scores indicating greater flexibility. |
Baseline, 6-8 weeks and 12 weeks
|
|
High Frequency Heart Rate Variability (HF-HRV)
Zeitfenster: Baseline, 6-8 weeks, and 12 weeks
|
Heart rate variability during provocation of body image distress; greater variability indicates an increased capacity to modulate arousal and distress. Indexed by HF Power ms^2 (Induction-Rest). |
Baseline, 6-8 weeks, and 12 weeks
|
|
Change From Baseline in Biased Processing of Body Image Stimuli Relative to Neutral Stimuli
Zeitfenster: Baseline, 6-8 weeks, and 12 weeks
|
Biased processing of stimuli is assessed using an emotional Stroop task with body image and neutral stimuli. Improvements are indicated by decreases in bias score (decreases in difference in reaction time between evocative and neutral stimuli). |
Baseline, 6-8 weeks, and 12 weeks
|
|
CompACT-10 (Comprehensive Assessment of Acceptance and Commitment Therapy)
Zeitfenster: Baseline, 6-8 weeks, 12 weeks
|
10-item measure assessing psychological flexibility. Total scores range from 10 to 70 with higher scores indicating greater flexibility. |
Baseline, 6-8 weeks, 12 weeks
|
|
Number of Eye Gaze Fixations on Pathology-relevant, Body-image Stimuli
Zeitfenster: Baseline, 6-8 weeks, 12 weeks
|
Number of fixations on body and food related images presented during HF-HRV task. |
Baseline, 6-8 weeks, 12 weeks
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- Pro00111571
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .