Sleep and Activity For Eating Disorders
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorIstituto Auxologico Italiano
About this trial
The SAFE (i.e., Sleep and Activity For Eating disorders) study aims to investigate the characteristics of sleep, daytime activity, and circadian rhythms in a sample of patients with eating disorders-specifically anorexia nervosa, bulimia nervosa, and binge-eating disorder-as well as the relationship between these variables and physiological parameters (i.e., body mass index, hormone levels, blood chemistry parameters) and psychological parameters (i.e., levels of depression and anxiety, body image, eating-disorder symptoms).
Eligibility criteria
Qualifiers
a) Age over 18 and under 65;
b) Diagnosis of anorexia nervosa, bulimia nervosa, or binge-eating disorder, as indicated by DSM-5-TR criteria;
c) Adherence to the rehabilitation program.
Disqualifiers
a) Presence of severe bradycardia (BPM < 35);
b) Severe malnutrition (BMI < 10);
c) Presence of severe psychopathology other than the eating disorder (e.g., schizophrenia);
d) Need to modify psychotropic or sleep-inducing pharmacological therapy during the rehabilitation program.
Trial design
Treatments tested in this trial
- Actigraphy
- Collection of biological parameters
- Psychological testing
Treatment groups
75 Participants
are divided into 3 treatment groupsSponsors and collaborators
Istituto Auxologico Italiano
Lead sponsor
University of Roma La Sapienza
Collaborator
Source ClinicalTrials.gov