NCT07022873

Brief Summary

The goal of this clinical trial is to investigate the efficacy of an online group prevention program developed for women at risk for eating disorders with randomized controlled trial. The main questions it aims to answer are:

  • Does the ACT intervention lead to a significant difference in disordered eating behaviors among individuals at risk for eating disorders?
  • Does the ACT intervention lead to a significant difference in body dissatisfaction among individuals at risk for eating disorders?
  • Does the ACT intervention lead to a significant difference in obsessive-compulsive and borderline personality beliefs among individuals at risk for eating disorders?
  • Does body image flexibility significantly affect the impact of the ACT intervention on disordered eating behaviors?
  • Do self-as-context, cognitive defusion, and present-moment awareness significantly affect the impact of the ACT intervention on disordered eating behaviors? Participant will: Join the online 4-session ACT-based group program Fill the measures at pre-test, post-test and follow-up assessment.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 21, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 8, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 15, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

June 15, 2025

Status Verified

May 1, 2025

Enrollment Period

5 months

First QC Date

June 8, 2025

Last Update Submit

June 8, 2025

Conditions

Keywords

disordered eatingeating pathologypreventioneating disorders

Outcome Measures

Primary Outcomes (1)

  • Disordered eating, assesed 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), 3-month follow-up

Secondary Outcomes (7)

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

    Baseline (pretest), week 4(posttest), 3-month follow-up

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

    Baseline (pretest), week 4(posttest), 3-month follow-up

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

    Baseline (pretest), week 4(posttest), 3-month follow-up

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

    Baseline (pretest), week 4(posttest), 3-month follow-up

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

    Baseline (pretest), week 4(posttest), 3-month follow-up

  • +2 more secondary outcomes

Study Arms (2)

Experimental group

EXPERIMENTAL

ACT based eating disorder prevention program. 4 sessions of 1.5 hours, held once a week

Other: ACT-ED: Acceptance and Commitment Therapy based eating disorder prevention program

Waiting-list control group

NO INTERVENTION

Waiting-list control group

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
Experimental group

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
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
To implement participant blinding, a deception procedure was used. All participants were informed that, due to high demand, they would begin the study at different time points. They were also told that the timing of their participation would be determined randomly.
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: There are two groups: experimental and control. Control group will receive the intervention after the follow-up assessment.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD candidate

Study Record Dates

First Submitted

June 8, 2025

First Posted

June 15, 2025

Study Start

February 21, 2025

Primary Completion

August 1, 2025

Study Completion

August 1, 2025

Last Updated

June 15, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will share

IPD used in the results publication. Data will be shared after being anonymized.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Beginning with the publication of results and ending 2 years after the publication of results.
Access Criteria
The documents will be accessible by requesting approval from the responsible researcher. It will be shared with those who have sufficient justification.

Locations