Treatment of Eating Disorders - a Randomised, Controlled, Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 128
- 试验地点
- 2
- 主要终点
- Effectiveness of treatment, evaluated through the change in symptoms of eating disorder
研究概览
简要总结
"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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The one transferring results from lab's and questionaires to SPSS are blinded for group affiliation.
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Cognitive Behaviour Therapy
Treatment with small groups following a modified protocol first described by Fairburn 2008
干预措施: Cognitive Behaviour Therapy (Behavioral)
Physical activity and dietary therapy
Treatment with guided physical activity and dietary therapy in small groups
干预措施: Physical Activity and Dietary Therapy (Behavioral)
结局指标
主要结局
Effectiveness of treatment, evaluated through the change in symptoms of eating disorder
时间窗: 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)
次要结局
- 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))
研究者
Professor Jorunn Sundgot-Borgen
Professor
Norwegian School of Sport Sciences