- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07559552
ACT-Based Group Therapy and Mobile Application Intervention for Emotional Eating (ACT-EE)
The Effect of Acceptance and Commitment Therapy and a Mobile App on Emotional Eating, Emotion Regulation, and Psychological Flexibility in Overweight Individuals
This study aims to evaluate the effects of an Acceptance and Commitment Therapy (ACT)-based group therapy program, combined with an ACT-based mobile app, on emotional eating, emotion regulation, and psychological flexibility in overweight individuals. Emotional eating is a condition in which individuals frequently use eating behavior as a coping mechanism for negative emotions.
Participants will be randomly assigned to intervention groups receiving ACT-based group therapy, ACT-based group therapy combined with an ACT-based mobile app, or a control group. The intervention will last six weeks and will include structured group sessions as well as mobile-based exercises, reminders, and coping strategies.
Outcome measures will include emotional eating, emotion regulation, and psychological flexibility. Assessments will be conducted at baseline, post-intervention, and during the follow-up phase. The findings of this study are expected to contribute to the development of accessible and effective interventions for emotional eating.
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
Research Objective The aim of this research is to examine the effect of acceptance and commitment therapy and acceptance and commitment therapy-based mobile application use on emotional eating, emotion regulation skills, and psychological resilience levels of overweight individuals. "Research Aim and Type The aim of this research is to examine the effect of acceptance and commitment therapy and acceptance and commitment therapy-based mobile application use on emotional eating, emotion regulation skills, and psychological resilience levels of overweight individuals.
The research was planned as a prospective, parallel, three-group (1:1:1) randomized controlled trial (RCT).
Research Variables Independent variables: Sociodemographic characteristics of the participants Dependent variables: Emotional eating, emotion regulation skills, psychological resilience Research Population and Sample The research population consists of individuals with a BMI of 25 and above living in Zonguldak province, Türkiye. The research sample consists of individuals with a Body Mass Index (BMI) of 25 and above who applied to the Nutrition and Dietetics outpatient clinics of Zonguldak Atatürk State Hospital and Zonguldak Karadeniz Ereğli State Hospital. The sample size of the research was calculated using G*Power 3.1.9.7 software. In the calculation made A three-group research design with an effect size of 0.815, a 5% margin of error, and a 95% power level is expected to reach a sample of 66 individuals. Considering the high power of the test and potential losses, the target sample size is 78 individuals. The sample size for each group is calculated as 26 individuals (KCT: 26, KCT+Mobile Application: 26, Waiting List: 26). Research data will be collected using an Information Form, the Emotional Eating Subscale of the Dutch Eating Behavior Questionnaire, the Difficulties in Emotion Regulation Scale (DERS), and the Acceptance and Action Form-II. The researcher has completed a 40-hour theoretical and practical training in 'Acceptance and Commitment Therapy (ACT)' organized by the Association of Contextual Behavioral Sciences and Psychotherapies and the Association of Cognitive Behavioral Psychotherapies. Additionally, the researcher has received four hours of training in the "Emotion Regulation Training Program" organized by Başkent Psychology Workshop and the Addiction Academy. Ethical committee approval required for the research (Date: (Received on 05.03.2025, Number: 36721). Permission was obtained from the Zonguldak Provincial Health Directorate for institutional permissions. Permission was obtained from the authors for the data collection forms used in the research. Individuals participating in the research will be informed in accordance with the Helsinki Declaration and their written and verbal consent will be obtained.
A group therapy intervention program was developed by the researcher in line with the literature. The program was planned with the aim of helping overweight individuals identify the problems they experience with emotional eating and emotion regulation, to define/understand the emotions that cause emotional eating, and to learn to live with these emotions instead of trying to prevent them. The relevant program was submitted to expert opinion, and after expert opinions, the necessary adjustments were made and the final version was prepared. In user-centered applications, the focus is on understanding and adapting to the users' perspective during the development phase of digital interventions. Including users in the process from the planning stage, conducting qualitative interviews, goes beyond evaluating usability and satisfaction and contributes to the creation of the psychosocial context of the intervention. Accordingly, in the second stage, for the design of the mobile application, data was collected from individuals experiencing emotional eating problems and from those with emotional eating, emotion regulation skills, and Experienced psychiatric nurses, psychiatrists, psychologists, and software developers with expertise in mobile application design were consulted regarding the content and design of the mobile application. In the third stage, storyboards were designed by the researcher based on the literature and the opinions received in the second stage. The mobile application included short psychoeducational content on emotional eating and emotion regulation, acceptance and commitment therapy-based emotion monitoring and awareness exercises that participants can use in their daily lives, data entry areas that allow for daily monitoring, progress charts that will enable them to track themselves with weekly analyses, and motivational messages to support and remind them to use the mobile application. After the completion of the mobile application design, it was presented again to expert opinions and the opinions of individuals experiencing emotional eating problems, and simultaneous adjustments were made in line with the suggestions received. Participants will be able to access the mobile application with their personal email addresses and passwords. The researcher will be able to track user data from their own administrator panel. Informed consent forms will be obtained from participants before the mobile application is launched.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Merve Sarıtaş Arslan, RN, MSc
- Telefonní číslo: +90 544 673 71 55
- E-mail: saritas.merve@hotmail.com
Studijní záloha kontaktů
- Jméno: Elvan Emine Ata, Associate Professor, PhD
- Telefonní číslo: +90 505 316 47 07
- E-mail: elvanemine.ata@sbu.edu.tr
Studijní místa
-
-
Merkez
-
Zonguldak, Merkez, Turecko (Türkiye), 67000
- Zonguldak Atatürk State Hospital
-
Kontakt:
- Merve Sarıtaş Arslan, RN, MSc
- Telefonní číslo: +90 544 673 71 55
- E-mail: saritas.merve@hotmail.com
-
Kontakt:
- Elvan Emine Ata, PhD
- Telefonní číslo: +90 505 316 47 07
- E-mail: elvanemine.ata@sbu.edu.tr
-
Vrchní vyšetřovatel:
- Merve Sarıtaş Arslan, RN Msc
-
Dílčí vyšetřovatel:
- elvan emine ata, phD
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Agreeing to participate in the study,
- Being between 18-65 years of age,
- Having a body mass index ≤ 25 (BMI ≤ 29.9),
- Being able to read and write,
- Having an iOS or Android smartphone,
- Having internet access,
- Having a home environment suitable for online sessions (having a computer/smartphone, internet access at home, the patient being able to be alone in the room during the session, etc.),
Exclusion Criteria:
- Having communication problems that would prevent the interview,
- Having a diagnosis of a mental disorder, including an eating disorder, that would prevent participation in the study, or having concomitant serious medical conditions that could potentially jeopardize study participation.
- Having undergone bariatric surgery. • Being on the waiting list for bariatric surgery.
- Being pregnant, breastfeeding, or planning to become pregnant within the next 6 months.
- Receiving therapy/counseling for emotional eating and emotion regulation problems,
- Using a mobile application for emotional eating and emotion regulation problems,
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: ACT Group Therapy
Participants in this group will undergo a six-week structured group therapy program based on Acceptance and Commitment Therapy (ACT).
|
The Acceptance and Commitment Therapy (ACT)-based group therapy program is structured as one session per week for six weeks.
Sessions will last 60-90 minutes.
The sessions will focus on the core ACT processes: acceptance, cognitive dissociation, being present, contextual self, value identification, and value-oriented action.
Psychoeducation, experiential exercises, mindfulness practices, and group sharing will be used during the sessions.
Homework and practice tasks will be assigned between sessions to support participants in applying the skills they learn to their daily lives.
|
|
Experimentální: ACT Group Therapy + Mobile Application
Participants in this group will receive six weeks of Acceptance and Commitment Therapy (ACT)-based group therapy, and will have access to an ACT-based mobile application to support the therapy process.
|
The Acceptance and Commitment Therapy (ACT)-based group therapy program is structured as one session per week for six weeks.
Sessions will last 60-90 minutes.
The sessions will focus on the core ACT processes: acceptance, cognitive dissociation, being present, contextual self, value identification, and value-oriented action.
Psychoeducation, experiential exercises, mindfulness practices, and group sharing will be used during the sessions.
Homework and practice tasks will be assigned between sessions to support participants in applying the skills they learn to their daily lives.
The ACT-based mobile application was developed to support the therapy process.
The application offers psychoeducational content, ACT-based exercises, reminders, motivational messages, and tools to support the application of skills in daily life.
It also allows users to monitor their mood and eating behaviors.
Ostatní jména:
|
|
Žádný zásah: Waitlist Control Group
Participants in this group will be placed on a waiting list and will not receive any intervention during the study.
They will have access to the mobile application after the study is completed.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Emotional Eating Level
Časové okno: Baseline, post-intervention (6 weeks), and 3-month follow-up.
|
Participants' levels of emotional eating will be assessed using a validated and reliable self-report scale.
The DEBQ Emotional Eating subscale will be used in the assessment.
The scale measures individuals' eating behaviors in response to emotional states such as stress, sadness, and anxiety.
Higher scores indicate higher levels of emotional eating behavior.
|
Baseline, post-intervention (6 weeks), and 3-month follow-up.
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Changes in Emotion Regulation Skills
Časové okno: Baseline, post-intervention (6 weeks), and 3-month follow-up.
|
431 Participants' emotion regulation skills will be assessed using a validated and reliable self-report scale.
The scale measures individuals' ability to be aware of emotions, understand emotions, accept emotions, and manage emotional responses.
Higher scores indicate increased difficulty in emotion regulation.
Emotion regulation will be assessed using the Difficulty in Emotion Regulation Scale (DERS).
|
Baseline, post-intervention (6 weeks), and 3-month follow-up.
|
|
Changes in Acceptance and Action Form-II (AAP-II) Scores
Časové okno: Baseline, post-intervention (6 weeks), and 3-month follow-up.
|
Participants' levels of psychological resilience will be assessed using the Acceptance and Action Form-II (AAF-II).
AAF-II is a self-report-based scale that measures individuals' avoidance tendencies and levels of psychological rigidity in the face of challenging thoughts and feelings.
High scores on the scale indicate low psychological resilience, meaning increased psychological rigidity.
|
Baseline, post-intervention (6 weeks), and 3-month follow-up.
|
Spolupracovníci a vyšetřovatelé
Sponzor
Publikace a užitečné odkazy
Obecné publikace
- Litwin R, Goldbacher EM, Cardaciotto L, Gambrel LE. Negative emotions and emotional eating: the mediating role of experiential avoidance. Eat Weight Disord. 2017 Mar;22(1):97-104. doi: 10.1007/s40519-016-0301-9. Epub 2016 Jul 26.
- Guerrini Usubini A, Cattivelli R, Radaelli A, Bottacchi M, Landi G, Tossani E, Grandi S, Castelnuovo G, Sartorio A. Preliminary Results from the ACTyourCHANGE in Teens Protocol: A Randomized Controlled Trial Evaluating Acceptance and Commitment Therapy for Adolescents with Obesity. Int J Environ Res Public Health. 2022 May 5;19(9):5635. doi: 10.3390/ijerph19095635.
- Saritas M, Sukut O. The Effect of Solution-Focused Group Counseling on Emotional Eating Levels in University Students: A Randomized Controlled Trial. Psychol Rep. 2024 Oct 22:332941241293697. doi: 10.1177/00332941241293697. Online ahead of print.
Užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Poruchy výživy
- Nadměrná výživa
- Tělesná hmotnost
- Patologické stavy, příznaky a symptomy
- Chování
- Nutriční a metabolické nemoci
- Příznaky a symptomy
- Chování při krmení
- Společenské chování
- Sebeovládání
- Nadváha
- Emocionální regulace
- Emocionální jedení
- Motorická aktivita
- Hnutí
- Muskuloskeletální fyziologické jevy
- Muskuloskeletální a nervové fyziologické jevy
- Cvičení
Další identifikační čísla studie
- 36721-4/17
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na ACT-Based Group Therapy
-
Chinese University of Hong KongHarmony House; Hong Kong Jockey ClubNáborZneužívání dětí | Rodičovské vyhořeníHongkong