High Risk for Eating DisorderAcceptMENCT03693911
ACT to Prevent Eating Disorders: Evaluating a Gamified Prevention Program
A study testing Acceptance and Commitment Therapy in people with High Risk for Eating Disorder and Eating Disorders in Adolescence, run by University of Cyprus at 1 site in Cyprus.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 13 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- High Risk for Eating Disorder, Eating Disorders in Adolescence, Acceptance Processes
- What is being tested?
- Acceptance and Commitment Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteCyprus
- Study dates
- 14 Jan 2016to 30 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 13 to 25 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- not meeting inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Acceptance and Commitment Therapy
- Keywords
- gamification, Acceptance and Commitment Therapy, digitalized intervention
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and Commitment TherapyBehavioural
Also called AcceptME
6 digital and gamified session prevention program based on Acceptance and Commitment Therapy
| Study group | Role | What they receive |
|---|---|---|
| Prevention group | Experimental | AcceptME- digital gamified Acceptance and Commitment Therapy prevention program Receives: Behavioral: Acceptance and Commitment Therapy |
| Waitlist control | No intervention | Waitlist control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk for developing an Eating Disorder
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).
Measured: 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
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.
Measured: Post-intervention (following completion of digital session 6, approximately 6 weeks) and follow-up (1 month after post-intervention, approximately 10 weeks)
Secondary outcomes (3)
Body Dissatisfaction
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.
Measured: 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
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.
Measured: 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
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.
Measured: Post-intervention (following completion of digital session 6, approximately 6 weeks) and follow-up (1 month after post-intervention, approximately 10 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2018
- Study start14 Jan 2016
- Primary completion5 May 2018
- Study completion30 Jan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Risk for Eating DisorderStudies 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
- Parallel groups
- Model description
- Comparison between AcceptME and waitlist control group
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cyprus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Karekla, University of Cyprus
- Investigators
- Maria Karekla, PhD, Principal investigator, University of Cyprus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03693911
- Sponsor's protocol ID
- ΕΕΒΚ/ΕΠ/2013/05-2
- Acronym
- AcceptME
- Status last verified
- Oct 2018
- First submitted
- 30 Sep 2018
- Last updated
- 3 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACT to Prevent Eating Disorders: Evaluation of the AcceptME Digital Gamified Prevention Program Based on Acceptance and Commitment Therapy
- ClinicalTrials.gov ID
- NCT03693911
- Acronym / sponsor ID
- AcceptME / ΕΕΒΚ/ΕΠ/2013/05-2
- Keywords
- gamification, Acceptance and Commitment Therapy, digitalized intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 92 participants (actual)
- Lead sponsor
- University of CyprusUniversity, hospital or other
- Study start
- 14 Jan 2016 (actual)
- Primary completion
- 5 May 2018 (actual)
- Study completion
- 30 Jan 2019 (estimated)
- First posted
- 3 Oct 2018 (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.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Comparison between AcceptME and waitlist control group
| Arm | Type | Receives |
|---|---|---|
| Prevention group | Experimental | Behavioral: Acceptance and Commitment TherapyAcceptME- digital gamified Acceptance and Commitment Therapy prevention program |
| Waitlist control | No intervention | –Waitlist control group |
Who may qualify
- Ages
- 13 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- not meeting inclusion criteria
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 |
|---|---|---|
| Acceptance and Commitment TherapyAlso: AcceptME6 digital and gamified session prevention program based on Acceptance and Commitment Therapy | Behavioural | Prevention group |
Primary outcome
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).
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.
3 secondary outcomes
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)
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
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2018.
- Individual participant dataSharing planned: Undecided
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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.
Maria Karekla, PhD principal investigator
University of Cyprus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance and Commitment Therapy in people with High Risk for Eating Disorder and Eating Disorders in Adolescence, run by University of Cyprus at 1 site in Cyprus.
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 5 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 3 Oct 2018. 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 Cyprus. 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?
Results are not available in the source record.
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?
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)). The study lists 2 primary outcomes in all. 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 3 Oct 2018.