ACT to Prevent Eating Disorders: Evaluating a Gamified Prevention Program

NCT03693911 | Unknown

• 1 other identifier: ΕΕΒΚ/ΕΠ/2013/05-2
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

High Risk for Eating Disorder; Eating Disorders in Adolescence; Acceptance Processes

Keywords

gamification; Acceptance and Commitment Therapy; digitalized intervention

Outcome Measures

Primary Outcomes (2)

• 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).

  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.

  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

  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

  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

  Post-intervention (following completion of digital session 6, approximately 6 weeks) and follow-up (1 month after post-intervention, approximately 10 weeks)

Other Outcomes (2)

• Cognitive Defusion

  Assessed at the beginning of each of the 6 digital sessions

• Values consistent actions

  Assessed at the beginning of each of the 6 digital sessions

Study Arms (2)

Prevention group

EXPERIMENTAL

AcceptME- digital gamified Acceptance and Commitment Therapy prevention program

Behavioral: Acceptance and Commitment Therapy

Waitlist control

NO INTERVENTION

Waitlist control group

Interventions

Acceptance and Commitment Therapy BEHAVIORAL

6 digital and gamified session prevention program based on Acceptance and Commitment Therapy

Also known as: AcceptME

Prevention group

Eligibility Criteria

• Age: 13 Years - 25 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

Sponsors & Collaborators

• University of Cyprus: lead

Study Sites (1)

University of Cyprus

Nicosia, Non-US/Non-Canadian, 1678, Cyprus

Location

MeSH Terms

Conditions

Behavior

Interventions

Acceptance and Commitment Therapy

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Maria Karekla, PhD

  University of Cyprus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking was carried out
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Comparison between AcceptME and waitlist control group

Study Record Dates

• First Submitted: September 30, 2018
• First Posted: October 3, 2018
• Study Start: January 14, 2016
• Primary Completion: May 5, 2018
• Study Completion: January 30, 2019
• Last Updated: October 3, 2018

Record last verified: 2018-10

Locations

CY (1)