Neurobiology of Eating Disorders Treatments
- Conditions
- Anorexia NervosaBulimia Nervosa
- Interventions
- Behavioral: CBT (Cognitive Behavioral Therapy)Other: IBPP (individual psychology brief psychotherapy)Dietary Supplement: nutritional rehabilitation
- Registration Number
- NCT01990755
- Lead Sponsor
- University of Turin, Italy
- Brief Summary
Background. Treatments of eating disorders result too often in partial psychological and physical remission, chronic course, dropout, relapse and death, with no fully known explanations for this failure. In order to clarify this problem, we conducted a three branches study to identify the biochemical background of cognitive-behavioral psychotherapy (CBT), individual psychology brief psychotherapy (IBPP), and psychotherapy-pharmacotherapy with CBT+olanzapine in anorexics (AN) and bulimics (BN) by measuring the levels of plasma homovanillic acid (HVA) for dopamine secretion, plasma 3-methoxy-4-hydroxy-phenylglycol (MHPG) for noradrenalin secretion, and platelet \[3 Hydrogen\]-Paroxetine-binding Bmax and Kd for serotonin transporter function. The data were then compared with psychopathological and physical alterations. Methods. Branch 1 investigated the effects of 4 months of CBT on plasma HVA, MHPG and \[3 Hydrogen\]-Par-binding in 14 AN-restricted, 14 AN-bingeing/purging, and 22 BN inpatients. Branch 2 investigated the effects of 4 months of IBPP on plasma HVA in 15 AN and 17 BN outpatients. Branch 3 investigated the effect of 3 months of CBT+olanzapine (5 mg/day) in 30 AN outpatients. The data are analyzed using one-way ANOVA for repeated measures for the changes between basal and post-treatment biological and psychological parameters, two-way ANOVA for repeated measures for the differences in the psychobiological data in the 3 groups, Spearman's test for the correlations between basal and final changes in the psychological and biological scores.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 112
- eating disorders full diagnosis according to Diagnostic and Statistical Manual (DSM-IV)
- age between 15 and 35
- female gender
- associated major psychiatric problems
- mental retardation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CBT (Cognitive Behavioral Therapy) CBT (Cognitive Behavioral Therapy) Investigates the effects of cognitive-behavioral therapy (CBT), on the secretion of brain dopamine (DA), noradrenalin (NE) and serotonin (5-HT) in a group of 50 female inpatients, 14 with AN restricter type (AN-R), 14 with the bingeing-purging type (AN-BP), and 22 with BN. Associated intervention (non of interest): psychiatric management (with tranquillizer: delorazepam), nutritional rehabilitation CBT (Cognitive Behavioral Therapy) nutritional rehabilitation Investigates the effects of cognitive-behavioral therapy (CBT), on the secretion of brain dopamine (DA), noradrenalin (NE) and serotonin (5-HT) in a group of 50 female inpatients, 14 with AN restricter type (AN-R), 14 with the bingeing-purging type (AN-BP), and 22 with BN. Associated intervention (non of interest): psychiatric management (with tranquillizer: delorazepam), nutritional rehabilitation IBPP (IP brief psychotherapy ) IBPP (individual psychology brief psychotherapy) Investigates the effects in 15 AN and 17 BN patients of an individual psychology brief psychotherapy (IBPP) on psychological alterations and DA secretion measured as peripheral blood values of HVA before and after treatment. Associated intervention (non of interest): psychiatric management (with tranquillizer: delorazepam), nutritional rehabilitation. IBPP (IP brief psychotherapy ) nutritional rehabilitation Investigates the effects in 15 AN and 17 BN patients of an individual psychology brief psychotherapy (IBPP) on psychological alterations and DA secretion measured as peripheral blood values of HVA before and after treatment. Associated intervention (non of interest): psychiatric management (with tranquillizer: delorazepam), nutritional rehabilitation. CBT + OLANZAPINE (5 MG) nutritional rehabilitation The study evaluated in 18 AN-R and 12 AN-BP patients the effects of CBT and of CBT associated with orally administered 5 mg olanzapine on the psychopathological aspects of the disease and on the secretion of HVA. Associated intervention (non of interest): psychiatric management (with tranquillizer: delorazepam), nutritional rehabilitation CBT + OLANZAPINE (5 MG) CBT + OLANZAPINE The study evaluated in 18 AN-R and 12 AN-BP patients the effects of CBT and of CBT associated with orally administered 5 mg olanzapine on the psychopathological aspects of the disease and on the secretion of HVA. Associated intervention (non of interest): psychiatric management (with tranquillizer: delorazepam), nutritional rehabilitation CBT (Cognitive Behavioral Therapy) delorazepam Investigates the effects of cognitive-behavioral therapy (CBT), on the secretion of brain dopamine (DA), noradrenalin (NE) and serotonin (5-HT) in a group of 50 female inpatients, 14 with AN restricter type (AN-R), 14 with the bingeing-purging type (AN-BP), and 22 with BN. Associated intervention (non of interest): psychiatric management (with tranquillizer: delorazepam), nutritional rehabilitation IBPP (IP brief psychotherapy ) delorazepam Investigates the effects in 15 AN and 17 BN patients of an individual psychology brief psychotherapy (IBPP) on psychological alterations and DA secretion measured as peripheral blood values of HVA before and after treatment. Associated intervention (non of interest): psychiatric management (with tranquillizer: delorazepam), nutritional rehabilitation. CBT + OLANZAPINE (5 MG) delorazepam The study evaluated in 18 AN-R and 12 AN-BP patients the effects of CBT and of CBT associated with orally administered 5 mg olanzapine on the psychopathological aspects of the disease and on the secretion of HVA. Associated intervention (non of interest): psychiatric management (with tranquillizer: delorazepam), nutritional rehabilitation
- Primary Outcome Measures
Name Time Method change in brain secretion of Dopamine at 6 months 6 months plasma homovanillic acid (HVA) measured before and after the therapeutic intervention in each branch.
change in brain secretion of Noradrenaline at 6 months 6 months plasma 3-methoxy-4-hydroxyphenylglycol (MHPG) measured before and after the therapeutic intervention in each branch
change in brain secretion of serotonin at 6 months 6 months the platelet paroxetine binding (\[3 Hydrogen\]-Par-binding): Bmax (maximum binding capacity) and Kd (dissociation constant) measured before and after the therapeutic intervention in each branch.
- Secondary Outcome Measures
Name Time Method Depressive Psychopathology improvement after 6 months 6 months Beck Depression Inventory (BDI)
Eating Psychopathology improvement after treatments at 6 months 6 months Eating Disorders Examination-12 (EDE 12)
Anxiety improvement after 6 months 6 months State-Trait Anxiety Index (STAI) Form-Y-1
Impulsiveness improvement after 6 months 6 months Barratt Impulsiveness Scale
Self-rated Biochemical improvement after 6 months 6 months Rosenberg Self-Biochemical Scale
Personality improvement after 6 months 6 months Temperament and Character Inventory (TCI)
Trial Locations
- Locations (1)
Villa Garda
🇮🇹Garda, Veneto, Italy