Cognitive Remediation Therapy (CRT) in adults with obesity – a randomised-controlled efficacy trial
- Conditions
- E66.99
- Registration Number
- DRKS00009333
- Lead Sponsor
- IFB AdipositasErkrankungenVerhaltensmedizinUniversitätsklinikum Leipzig AöR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 270
•Patients of the IFB AdipositasAmbulanz presentig with obesity grade 2 or 3 (BMI = 35,0 kg/m2)
•planned participation in the conservative weight reduction program of the IFB AdipositasAmbulanz
•Age = 18 Jahre
•Swritten informed consent
•sufficient knowledge of the German language
•ability to participate in regular appointments at the IFB Studienambulanz
•severe illness (eg neurological diseases, stroke, head injuries)
•considerable mental/psychosomatic comorbidity (eg. psychotic disorder, current suicidality, ongoing substance abuse, hyperkinetic disorder, intelligence reduction, developmental disorder)
•insufficient compliance
•pregnant and nursing women
•participation in other interventional trials
•ongoing psychtherapy
•Physical, metal or other inability to participate in the required tests (eg hearing-, visual or speaking inability)
•concomitant medication influencing weight and/ executive functions (eg antipsychotics, sedatives, hypnotics)
•previous or planned bariatric surgery
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentual change in weight loss between Baseline (t0) and 6-months-follow-up (t2)
- Secondary Outcome Measures
Name Time Method Changes in the following parameters: (a) exekutiv functions (t0 vs. t1); (b) behavioral indicators for weight loss (t0 vs. t2); (c) compliance with conservative weight loss therapy; (d) mental health (t0 vs. t2); (e) physical health (t0 vs. t2). In addition: changes in these parameters until 12-months follow-up (t3).<br>Weight loss will be analysed in kg. <br>All other parameters will be evaluated using validated tools for<br>•exekutive functions (eg. Iowa Gambling Task)<br>•cognitiven funktions (eg. vigilance (WAFV of the Vienna-Test-System)<br>•behavioral indicators for weight loss (eg. physical activity (IPAQ))<br>•/validated questionaires for mental health (eg. overall psychopathology (PHQ-D))