Treatment of Eating Disorders - a Randomised, Controlled, Prospective Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Bulimia Nervosa
- Sponsor
- Norwegian School of Sport Sciences
- Enrollment
- 128
- Locations
- 1
- Primary Endpoint
- Effectiveness of treatment, evaluated through the change in symptoms of eating disorder
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
"Eating disorders" includes anorexia nervosa, bulimia nervosa, binge eating and other specified feeding or eating disorder (OSFED). Common to all is the intensively occupation to control food intake, body image and body weight. Most people with this kind of disorder don't reach for professional help, or there may be more than 4 years before they do. Cognitive behavior therapy is the foremost method of treatment of eating disorders, but up to 30-50% of the patients don't respond to this. The investigators find it important to identify science based alternatives of therapy, as this may reduce the health concern, and broaden the choice of therapy methods. A former study by Sundgot-Borgen et al in 2002, found guided physical activity to reduce symptoms of bulimia nervosa just as good as the traditional cognitive therapy.
The primary objective of the project is to see whether the combination of physical exercise and dietary therapy is more effective in treating eating disorders, than cognitive therapy.
Secondly, the investigators want to see whether there are any differences with regard to the individual satisfaction of treatment method, and to associated costs. Interviews with a sufficient number of participants from the PED-t arm to meet data saturation criteria, and all theraphists in the new treatment offer, will give uniqe insight to experiences with the treatment method and the delivery of treatment.
Detailed Description
Subjects are recruited through primary doctors, social media and newspapers, and will be included continuously by screening interviews. There will be a randomization into two treatment groups (cognitive behavior, or physical activity and nutrition education) to be followed for 16 weeks. Each week includes one meeting of group therapy (90 minutes) and homework related to treatment, and for 4 weeks midway there will be two therapy meetings pr week (a total of 20 meetings). Post tests are planned at week 17, and at 6, 12, and 24 months after treatment. Participants reqruited during ongoing treatment groups are placed on a waitlist, serving as controls to the treatment groups.
Investigators
Professor Jorunn Sundgot-Borgen
Professor
Norwegian School of Sport Sciences
Eligibility Criteria
Inclusion Criteria
- •BMI 17,5-35,
- •Age of 18-40 years,
- •DSM-5 criteria of bulimia nervosa,
- •DSM-5 criteria of Binge eating disorder
- •Living nearby Norwegian School of Sports Sciences, NSSS, in Oslo (Norway)
Exclusion Criteria
- •Age \<18 and \>40 years
- •BMI \<17,5 and \>35
- •Pregnancy
- •Competing/experienced athlete
- •Anorexia nervosa
- •Currently, or during the past 2 years, in active treatment with cognitive therapy
- •Other personality disturbances
- •Suicidality
Outcomes
Primary Outcomes
Effectiveness of treatment, evaluated through the change in symptoms of eating disorder
Time Frame: Pre-test in week 0, Post-tests (week 17), and at 6, 12, and 24 months after intervention.
Change in ED-symptoms are evaluated through screening and surveys: EDE-questionaire (Episodes of binge eating, episodes of purging, concern for body weight and appearance)(Fairburn, 2008), Clinical Impairment Assessment (CIA) (Fairburn, 2008), Eating Disorder Inventory-3 (EDI) (Garner, 2004), Eating Disturbance Scale (EDS-5) (Rosenvinge et al., 2000), DSM-5 (APA, 2013)
Secondary Outcomes
- Experiences of the treatment method for eating disorders(Post-test (by 24th month post-treatment))
- Expectations of treatment method for eating disorders(Pre-test)
- Associated cost with treatment method(Post-test (by 24th month post-treatment))
- Group climate(week 1-16)
- Working AIliance(week 1-16)
- Associated cost With treatment method(Post-test (by 12th month post-treatment))
- Change in eating disorder behavior and cognitions related to body figure and bodyweight(Week 1-16 during treatment)
- Global measurement of general psychopathology(Post-test (by 24th month post-treatment))