ACT to Prevent Eating Disorders: Evaluating a Gamified Prevention Program (AcceptME)

October 1, 2018 updated by: Maria Karekla, University of Cyprus

ACT to Prevent Eating Disorders: Evaluation of the AcceptME Digital Gamified Prevention Program Based on Acceptance and Commitment Therapy

Eating Disorders (ED) constitute a serious public health issue that affects predominantly women and appears typically in adolescence or early adulthood. ED are extremely difficult to treat as these disorders are ego-syntonic and many patients do not seek treatment. As ED are associated with significant adverse medical and psychological consequences, it is vital to focus on the development of successful prevention programs. Even though, in the last two decades significant steps have been made over the development of efficacious and effective ED prevention programs, there is room for improvement in regards to effect sizes. Prevention programs for ED to date have focussed on either reducing the pursuit of the thin ideal or on disputing and replacing unrealistic thoughts with regard to food, body and weigh. There is a growing body of evidence supporting the functional relationship between ED symptomatology and control of emotional states either by avoiding or inhibiting emotional responses. The present study aimed to investigate the effectiveness and acceptability of a digital Acceptance and Commitment Therapy (ACT) based prevention program in comparison to a wait-list control group for young women identified to be at risk for ED. The goals of the study were to describe the development of the AcceptME protocol and digitalized program, assess participants' feedback and the acceptability of the program, and examine the effectiveness of the ACT-based prevention program compared to a wait-list control group. This prevention program has several innovations: a) it is based on ACT theory and practices; b) it uses gamification principles to create a program appealing to adolescents; c) it targets behaviour change in individuals via helping a digital character overcome difficulties in the digitalized program.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Eating Disorders (EDs) constitute a serious public health issue that affects mainly women and appears typically in adolescence or early adulthood. EDs often result in serious physical health consequences as well as enduring psychological difficulties and behavioral complications. Prevention of EDs is paramount as it will reduce such adverse effects, improve the quality of the patient's and his/her family's life and decrease costs incurred by EDs. To date, prevention approaches have not been uniformly effective for EDs and as a consequence there is great room for improvement. There is a growing body of evidence supporting the functional relationship between EDs symptomatology and controlling emotional states either by avoiding or inhibiting the emotional response. Furthermore, theories support that AN begins with a general need of self control and not just emotional control. Current prevention programs for EDs have largely ignored on the problem concerning self-control. This study will propose a new prevention program based on the cognitive-behavioral theory, which suggests that one of the main features of anorexia is a general need of self-control, and the psychological inflexibility theory, which suggests that this need of experiential control may lead to a broader state of psychological inflexibility. A prevention program based on mindfulness, acceptance and change is hypothesized to be able to target ineffective control strategies in individuals at high-risk for developing EDs, prior to the disorder manifesting itself. A treatment which is based on mindfulness and acceptance is Acceptance and Commitment Therapy (ACT), a 3rd wave CBT that targets ineffective control strategies and inflexibility found in a range of psychopathology problems. This study will apply an ACT based prevention program for EDs in an internet based delivery modality delivered to high-risk individuals. The hypotheses made are the following: participants receiving the prevention program will 1) develop greater body image flexibility, 2) decrease their control behaviours (e.g. dieting, exercising, body image avoidance behaviors), and 3) have significantly fewer ED symptoms, decreased body dissatisfaction, decreased risk for developing EDs and have significantly higher quality of life, as compared to the wait-list control group at the end of prevention and at 1-month follow up. We also hypothesized that changes in ACT-related process measures (defusion, mindfulness, values, willingness, body image flexibility, self as context) will mediate improvements in EDs outcome measures (eating disorder risk, eating disorder symptoms, dieting, exercising, body image avoidance behaviour). For the purposes of the study, high-risk participants developing EDs will be recruited from high schools and vocational schools. Participants will be randomly assigned either to the internet-based ACT intervention or the wait list control group. Participants will complete process and outcome measures at baseline, post treatment and follow-up. Results will be then analyzed and conclusions will be made. Repeated measures MANOVA will be used to assess the changes and the differences between the prevention group and the wait list control group. Furthermore, to assess whether ACT variables such as values, mindfulness, defusion, self as context, willingness will mediate ED symptoms mediation analysis will be used.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
92

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Cyprus
    • Non-US/Non-Canadian
      • Nicosia, Non-US/Non-Canadian, Cyprus, 1678
        • University of Cyprus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

9 years to 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • females
  • aged 13-25 years,
  • voluntary participation and parental consent for ages lower than 18 years,
  • good working knowledge of the Greek language and
  • report a score of greater that 52 at the Weight Concern Scale (Killen et al., 1996) thus, indicating that they are at high risk for developing ED.

Exclusion Criteria:

  • not meeting inclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Prevention group
AcceptME- digital gamified Acceptance and Commitment Therapy prevention program
Behavioral: Acceptance and Commitment Therapy
6 digital and gamified session prevention program based on Acceptance and Commitment Therapy
Other Names:
  • AcceptME
No Intervention: Waitlist control
Waitlist control group

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Risk for developing an Eating Disorder
Time Frame: Post-intervention (following completion of digital session 6, approximately 6 weeks) and follow-up (1 month after post-intervention, approximately 10 weeks)
Change in risk for developing an Eating Disorder as assessed via the Weight Concerns Scale (WCS; Killen et al., 1994) assessing fear of weight gain, worry about weight and body shape, the importance of weight, diet history, and perceived fatness. Specifically, scores above 52 are associated with an increased risk of developing an eating disorder within 4 years for adolescent girls (Killen et al.,1996).
Post-intervention (following completion of digital session 6, approximately 6 weeks) and follow-up (1 month after post-intervention, approximately 10 weeks)
Body Image Inflexibility
Time Frame: Post-intervention (following completion of digital session 6, approximately 6 weeks) and follow-up (1 month after post-intervention, approximately 10 weeks)
Change in Body Image Inflexibility as assessed via the Body Image-Acceptance and Action Questionnaire (BI-AAQ; Sandoz et al., 2009). This scale assesses body image acceptance, "the extent to which an individual actively contacts perceptions, thoughts, beliefs, and feelings about his or her body without directly attempting to change their intensity, frequency or form" (Sandoz et al., 2009, p. 8). Scores range from 7-84. Higher summed scores indicate higher body image inflexibility.
Post-intervention (following completion of digital session 6, approximately 6 weeks) and follow-up (1 month after post-intervention, approximately 10 weeks)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Body Dissatisfaction
Time Frame: Post-intervention (following completion of digital session 6, approximately 6 weeks) and follow-up (1 month after post-intervention, approximately 10 weeks)
Change in Body Dissatisfaction as assessed via the Body Shape Questionnaire-8C (BSQ-8C; Cooper et al., 1987). is a self report short version of the 34-item BSQ, assesing body dissatisfaction as a result of feelings of being fat. The BSQ-8C includes 8 questions extracted from the full version and it was found to be the most favorable version according to Pook and colleaques (2008), as it presented with excellent treatment sensitivity to change in the course of therapy. It is rated on a 6-point scale from "never" to "always. Higher scores indicate more body dissatisfaction.
Post-intervention (following completion of digital session 6, approximately 6 weeks) and follow-up (1 month after post-intervention, approximately 10 weeks)
Quality of life
Time Frame: Post-intervention (following completion of digital session 6, approximately 6 weeks) and follow-up (1 month after post-intervention, )approximately 10 weeks
Change in Quality of life as assessed via the Youth Quality of Life Instrument-Short Form (YQOL-SF; Patrick & Edwards, 2013). The short-form includes 15 questions assessing domains of sense of self, social relationships, environment and general quality of life. The response scale ranges from 0 (not at all) to 10 (completely). The scores are summed and then transformed to a 0 to 100 scale, with a higher score representing higher quality of life.
Post-intervention (following completion of digital session 6, approximately 6 weeks) and follow-up (1 month after post-intervention, )approximately 10 weeks
Eating Disorder Symptomatology
Time Frame: Post-intervention (following completion of digital session 6, approximately 6 weeks) and follow-up (1 month after post-intervention, approximately 10 weeks)
Change in Eating Disorder Symptomatology as assessed via the Eating Disorder Examination Questionnaire (EDE-Q; Fairburn & Beglin, 1994). It is a self report version of the EDE interview, assessing the frequency of key behavioural features of eating disorders (i.e., measures the number of times and days a behaviour has occurred in a 4-weeks period). Four subscales (Restraint, Weight Concern, Shape Concern and Eating Concerns) and a global score is derived. The global score is used for purposes of this study.
Post-intervention (following completion of digital session 6, approximately 6 weeks) and follow-up (1 month after post-intervention, approximately 10 weeks)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cognitive Defusion
Time Frame: Assessed at the beginning of each of the 6 digital sessions
Change in Cognitive Defusion as assessed via the Figurative Cognitive Fusion Scale (FCDS; Karekla & Nikolaou, 2011). This is a single item scale assessing cognitive fusion schematically by indicating the relation between ones' self and worrisome thoughts (e.g. regarding body weight and shape in this case). The scale range is 1-10 with higher scores indicating greater levels of cognitive defusion whereas lower scores indicating more cognitive fusion.
Assessed at the beginning of each of the 6 digital sessions
Values consistent actions
Time Frame: Assessed at the beginning of each of the 6 digital sessions
Change in Values consistent actions as assessed via the The BULLs-eye Instrument of valued life (Lundgren & Dahl, 2006). This is a self report instrument evaluating participants' level of consistency and persistence in living in accordance to their values (rated on a scale from 1-10). The domains of value living are friendships/family, education/work, relationships/dating and health. Scores on each domain are averaged to yield an overall score. Higher scores indicate greater consistency in pursuing valued activities.
Assessed at the beginning of each of the 6 digital sessions

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Cyprus

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Maria Karekla, PhD, University of Cyprus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 14, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 5, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 30, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 30, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 1, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 3, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 3, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 1, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ΕΕΒΚ/ΕΠ/2013/05-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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