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Taking the LEAP: study protocol for a randomized, multicentre, naturalistic, efficacy trial of the compuLsive
Elin Monell1,2, Caroline Meyer3,4, Agnieszka Szwajda5
1Department of Medical Biostatistics and Epidemiology, Karolinska Institutet, Stockholm, Sweden. elin.monell@ki.se.
Background:
About half of Swedish eating disorder patients report exercising compulsively and compulsive exercise (CE) is prevalent in all diagnoses and both genders. Yet there are no systematic treatments targeting CE in specialist care. This study aims to evaluate the effects of The CompuLsive Exercise Activity TheraPy (LEAP) - a promising group treatment targeting compulsive exercise, in Swedish eating disorder patients.
Method:
One hundred twenty-eight adult females and males suffering from anorexia nervosa, bulimia nervosa or other specified feeding and eating disorders (type 1, 2, or 4) with CE will be recruited via four specialist eating disorder treatment units. Participants will be randomized to receive treatment as usual (control group) or treatment as usual plus LEAP (intervention group). The groups will be assessed on key variables (e.g., BMI, eating disorder symptoms, exercise cognitions and behaviors) at three occasions: initially, after 3 months and after 6 months.
Discussion:
The project takes place in a clinical setting, including both male and female patients with different eating disorder diagnoses with CE, enabling a good indication of the efficacy of LEAP. If our results are positive, LEAP has the potential of benefiting about half of the eating disorder population, with remission and recovery hopefully improving as a result.
Trial Registration:
The trial is registered with the ISRCTN registry (registration date 2020-03-25), trial ID: ISRCTN80711391 .
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