NCT06945796

Brief Summary

The goal of this clinical trial is to investigate the accessibility and feasibility of an online group prevention program developed for women at risk for eating disorders. Also, to conduct a preliminary analysis of treatment efficacy. The main questions it aims to answer are: Does ACT-ED an acceptable intervention for women at risk for eating disorders? Does intervention result in reduced eating pathology? Participants will: Join the online, 4-session ACT-based group program Fill the measures at Pre-test, post-test and follow-up assessment

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 18, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 11, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 25, 2025

Completed
Last Updated

June 10, 2025

Status Verified

April 1, 2025

Enrollment Period

3 months

First QC Date

April 11, 2025

Last Update Submit

June 5, 2025

Conditions

Keywords

disordered eatingeating pathologypreventioneating disordersearly intervention

Outcome Measures

Primary Outcomes (1)

  • Disordered eating, assessed by the Turkish form of the Eating disorder examination questionnaire (EDE-Q)

    Disordered eating is a risk factor for eating disorders. In a prevalence study conducted in Türkiye, individuals with EDE-Q scores of 3.03 and above were defined as a high-risk group (Deveci, 2020). In this study, EDE-Q scores were assessed for inclusion criteria during enrollment. Additionally, changes in EDE-Q scores are assessed at post-test and follow-up to assess treatment effect.

    Baseline (pretest), week 4(posttest), 1-month follow-up

Secondary Outcomes (7)

  • Body dissatisfaction, assessed by the Turkish form of Body shape Questionnaire (BSQ)

    Baseline (pretest), week 4(posttest), 1-month follow-up

  • Body image flexibility, assessed by the Turkish form of the Body Image Acceptance and Action Questionnaire (BI-AAQ)

    Baseline (pretest), week 4(posttest), 1-month follow-up

  • Psychological flexibility, assessed by Acceptance and Action Questionnaire (AAQ-II)

    Baseline (pretest), week 4(posttest), 1-month follow-up

  • Present moment awareness, assessed by the Turkish form of the Freiburg Mindfulness Inventory (FMI)

    Baseline (pretest), week 4(posttest), 1-month follow-up

  • Contextual Self, assessed by the Turkish form of the Self-As-Context Scale (SACS)

    Baseline (pretest), week 4(posttest), 1-month follow-up

  • +2 more secondary outcomes

Study Arms (1)

Group intervention

EXPERIMENTAL

ACT-based online group intervention. 4 sessions of 1.5 hours, held once a week

Other: ACT based eating disorder prevention program

Interventions

This intervention protocol was developed specifically for women who have body dissatisfaction and disordered eating behaviors. Based on the psychological flexibility model (hexaflex), it is designed to improve people's body image flexibility using Acceptance and Commitment Therapy techniques. Interventions related to the dimensions of the hexaflex were made during each session. The first session covers values and goal setting. The second session includes creative hopelessness, acceptance, and self-compassion. The third session covers defusion and mindfulness. The last session focuses on self-as-context exercises and the combined use of skills for committed action.

Also known as: ACT-ED
Group intervention

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsbiological females
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being a woman aged 18 years or older
  • Exhibiting disordered eating behaviors (EDE-Q score ≥ 3.03)
  • Experiencing body dissatisfaction (BSQ-34 score ≥ 110)

You may not qualify if:

  • Current or past diagnosis/treatment for an eating disorder
  • Currently receiving psychotherapy
  • Currently receiving psychiatric medication (not excluded if there has been no change in treatment in the last 6 months)
  • Having chronic psychiatric disorders (e.g. psychosis)
  • Having a substance addiction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ibn Haldun University Psychotherapy Application and Research Center (IPAM)

Istanbul, Basaksehir, 34480, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Disordered Eating BehaviorFeeding and Eating Disorders

Condition Hierarchy (Ancestors)

BehaviorMental DisordersSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Emine Serra Nebati

    Ibn Haldun University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 11, 2025

First Posted

April 25, 2025

Study Start

November 18, 2024

Primary Completion

February 2, 2025

Study Completion

February 2, 2025

Last Updated

June 10, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared due to confidentiality concerns and ethical considerations.

Locations