Eating Disorder SymptomsNCT07022873
ACT-ED: Randomized Controlled Trial of ACT-Based Eating Disorder Prevention Program
A study testing ACT-ED: Acceptance and Commitment Therapy based eating disorder prevention program in people with Eating Disorder Symptoms and Eating Pathology, run by Ibn Haldun University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Eating Disorder Symptoms, Eating Pathology, Disordered Eating Behaviors
- What is being tested?
- ACT-ED: Acceptance and Commitment Therapy based eating disorder prevention program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Feb 2025to Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being a woman aged 18 years or older
- Exhibiting disordered eating behaviors (EDE-Q score ≥ 3.03)
- Experiencing body dissatisfaction (BSQ-34 score ≥ 110)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ibn Haldun University Psychotherapy Application and Research Center (IPAM)
Istanbul, Basaksehir, 34480
About this study
Official title: ACT-ED: Acceptance and Commitment Therapy Based Eating Disorder Prevention Program
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:
Read more
- 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.
- Being tested
- ACT-ED: Acceptance and Commitment Therapy based eating disorder prevention program
- Keywords
- disordered eating, eating pathology, prevention, eating disorders
- Medical subject headings
- Disordered Eating Behavior, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACT-ED: Acceptance and Commitment Therapy based eating disorder prevention programOther
Also called ACT-ED
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | ACT based eating disorder prevention program. 4 sessions of 1.5 hours, held once a week Receives: Other: ACT-ED: Acceptance and Commitment Therapy based eating disorder prevention program |
| Waiting-list control group | No intervention | Waiting-list control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (pretest), week 4(posttest), 3-month follow-up
Secondary outcomes (7)
Body dissatisfaction, assesed by the Turkish form of Body shape Questionnaire (BSQ)
A total score of the questionnaire can be in the range of 34 to 204 where total score lower than 110 represents no concern, a total score between 110 and 137 represents mild concern, a total score between 138 and 166 represents moderate concern, and a total score higher than 167 represent severe concern. In this study, EDE-Q scores were assessed for inclusion criteria during enrollment; participans scores of 110 and above are included. Additionally, changes in EDE-Q scores are assessed at post-test and follow-up.
Measured: 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)
Body image flexibility (BIF) is a construct derived from the psychological flexibility model. BIF is defined as the capacity to experience perceptions, sensations, feelings, thoughts, and beliefs related to one's body without avoidance while acting in alignment with personal values. The BI-AAQ consists of 12 items; higher scores indicate lower BIF and increased body image inflexibility. In this study, this scale would be used to assess how one's relation with body image-related internal experiences changes after the prevention program.
Measured: Baseline (pretest), week 4(posttest), 3-month follow-up
Psychological flexibility, assesed by Acceptance and Action Questionnaire (AAQ-II)
The AAQ-II is designed to assess psychological flexibility defined as the capacity to be in contact with the present moment, fully aware of one's thoughts, emotions, and sensations. Higher scores indicate decreased psychological flexibility and increased experiential avoidance. In this study, the scale was used to assess changes in the general psychological flexibility.
Measured: Baseline (pretest), week 4(posttest), 3-month follow-up
Present moment awareness, assesed by the Turkish form of the Freiburg Mindfulness Inventory (FMI)
Present moment awareness is one of the dimensions of the psychological flexibility model. It is defined as the ability to fully engage with the present moment. Higher scores indicate better present moment awareness. In future studies, it is desired to examine which dimension of the psychological flexibility model has an effect on the treatment outcome. In this study, FMI was used to test its suitability in measuring change in this intervention.
Measured: Baseline (pretest), week 4(posttest), 3-month follow-up
Contextual Self, assesed by the Turkish form of the Self-As-Context Scale (SACS)
Contextual Self is one of the dimensions of the psychological flexibility model. It is defined as one's ability to view himself with a broader perspective. Higher scores indicate improved contextual self. In future studies, it is desired to examine which dimension of the psychological flexibility model has an effect on the treatment outcome. In this study, SACS was used to test its suitability in measuring change in this intervention.
Measured: Baseline (pretest), week 4(posttest), 3-month follow-up
Defusion, assesed by the Turkish form of the Cognitive Fusion Scale (CFS)
Defusion is one of the dimensions of the psychological flexibility model. It is defined as one's ability to separate himself from his thoughts. Higher scores indicate fusion, which is the opposite of defusion. In future studies, it is desired to examine which dimension of the psychological flexibility model has an effect on the treatment outcome. In this study, SACS was used to test its suitability in measuring change in this intervention.
Measured: Baseline (pretest), week 4(posttest), 3-month follow-up
Personality beliefs, assesed by the Turkish form of the Personality Beliefs Questionnaire- Short Form (PBQ-SF)
Obsessive-compulsive personality disorder and borderline personality disorder are the most common personality disorders in eating disorders. PBQ is designed to assess dysfunctional personality beliefs, and higher scores on a subscale indicate stronger dysfunctional beliefs related to the corresponding personality. In future studies, it is desired to examine how the personality beliefs are affected by the prevention program. In this study, PBQ-SF was used to test its suitability in measuring change in personality beliefs by this intervention.
Measured: Baseline (pretest), week 4(posttest), 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2025
- Study start21 Feb 2025
- Primary completionAug 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eating Disorder SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- There are two groups: experimental and control. Control group will receive the intervention after the follow-up assessment.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ibn Haldun University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emine Serra Nebati, Ibn Haldun University
- Investigators
- Emine Serra Nebati, Principal investigator, Ibn Haldun University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07022873
- Sponsor's protocol ID
- 2025/03-07
- Status last verified
- May 2025
- First submitted
- 8 Jun 2025
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD used in the results publication. Data will be shared after being anonymized.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACT-ED: Acceptance and Commitment Therapy Based Eating Disorder Prevention Program
- ClinicalTrials.gov ID
- NCT07022873
- Acronym / sponsor ID
- 2025/03-07
- Keywords
- disordered eating, eating pathology, prevention, eating disorders
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Ibn Haldun UniversityUniversity, hospital or other
- Study start
- 21 Feb 2025 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 15 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- There are two groups: experimental and control. Control group will receive the intervention after the follow-up assessment.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: ACT-ED: Acceptance and Commitment Therapy based eating disorder prevention programACT based eating disorder prevention program. 4 sessions of 1.5 hours, held once a week |
| Waiting-list control group | No intervention | –Waiting-list control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being a woman aged 18 years or older
- Exhibiting disordered eating behaviors (EDE-Q score ≥ 3.03)
- Experiencing body dissatisfaction (BSQ-34 score ≥ 110)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACT-ED: Acceptance and Commitment Therapy based eating disorder prevention programAlso: ACT-EDThis 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. | Other | Experimental group |
Primary outcome
Disordered eating, assesed by the Turkish form of the Eating disorder examination questionnaire (EDE-Q)
Time frame: Baseline (pretest), week 4(posttest), 3-month follow-up
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.
7 secondary outcomes
Body dissatisfaction, assesed by the Turkish form of Body shape Questionnaire (BSQ)
Time frame: 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)
Time frame: Baseline (pretest), week 4(posttest), 3-month follow-up
Psychological flexibility, assesed by Acceptance and Action Questionnaire (AAQ-II)
Time frame: Baseline (pretest), week 4(posttest), 3-month follow-up
Present moment awareness, assesed by the Turkish form of the Freiburg Mindfulness Inventory (FMI)
Time frame: Baseline (pretest), week 4(posttest), 3-month follow-up
Contextual Self, assesed by the Turkish form of the Self-As-Context Scale (SACS)
Time frame: Baseline (pretest), week 4(posttest), 3-month follow-up
Defusion, assesed by the Turkish form of the Cognitive Fusion Scale (CFS)
Time frame: Baseline (pretest), week 4(posttest), 3-month follow-up
Personality beliefs, assesed by the Turkish form of the Personality Beliefs Questionnaire- Short Form (PBQ-SF)
Time frame: Baseline (pretest), week 4(posttest), 3-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2025.
- Individual participant dataSharing planned: Yes. IPD used in the results publication. Data will be shared after being anonymized.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emine Serra Nebati principal investigator
Ibn Haldun University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACT-ED: Acceptance and Commitment Therapy based eating disorder prevention program in people with Eating Disorder Symptoms and Eating Pathology, run by Ibn Haldun University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disordered eating, assesed by the Turkish form of the Eating disorder examination questionnaire (EDE-Q) (time frame: Baseline (pretest), week 4(posttest), 3-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2025.