STRATOB: a Randomized Controlled Clinical Trial of Cognitive Behavioural Therapy and Brief Strategic Therapy With Telecare for Binge-eating Disorder
Condition: Obesity; Binge Eating Disorder
MeSH terms: Obesity; Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder
Study type: Interventional

Summary: 
      The STRATOB study is a two-arm randomized controlled clinical trial (RCT). The aims of this
      study are to compare the effectiveness of the BST (Brief Strategic Therapy) with the gold
      standard CBT (Cognitive Behavior Therapy) in a inpatient and telephone-based outpatient
      program in a sample of obese people with BED (Binge Eating Disorder) seeking treatment for
      weight reduction.
    

Detailed description: 
      Obesity constitutes one of the most important medical and public health problems of our time.
      It is considered as a chronic pathology and is widely recognized as a risk factor for many
      medical complications such as cardiovascular, orthopedic, pneumological and endocrinological
      diseases. Overweight and obesity is also linked with Binge Eating Disorder (BED). Binge
      eating disorder is characterized by frequent and persistent episodes of binge eating
      accompanied by feelings of loss of control and marked distress in the absence of regular
      compensatory behaviors. Functional interventions for significantly reduce weight, maintain
      weight loss and manage associated pathologies like BED are typically combined treatment
      options (dietetic, nutritional, physical, behavioral, cognitive-behavioral, pharmacological,
      surgical). Significant difficulties with regard to availability, costs, treatment adherence
      and long-term efficacy are present. Moreover most overweight and obese individuals regain
      about one third of the weight lost with treatment within 1 year [11] and they are typically
      back to baseline in 3 to 5 years.

      Treatment for BED is directed towards either the physical or psychopathological impairments
      and Cognitive behavior therapy (CBT) and Interpersonal Psychotherapy (IPT) are
      psychotherapies for BED indicated to target the eating disorder. Particularly CBT is the
      therapeutic approach indicated both in inpatient and in outpatient settings for BED. In
      recent years systemic and systemic-strategic psychotherapies have been implemented to treat
      patients with obesity and BED involved in familiar problems. Particularly a brief protocol
      for the systemic-strategic treatment of BED, using overall the strategic dialogue, has been
      developed by Nardone and Portelli in the Handbook of Brief Strategic Therapy (BST).

      Moreover telemedicine, a new promising low cost method, has been used for obesity with BED in
      outpatient settings in order to avoid relapses after the inpatient step of treatment and to
      keep on a continuity of care with to the involvement of the same clinical inpatient team.

      For these reasons, we developed STRATOB (Systemic and STRATegic psychotherapy for OBesity), a
      comprehensive two-phase stepped down program enhanced by telepsychology for the medium-term
      treatment of obese people with BED seeking intervention for weight loss. The core aspects of
      STRATOB are the hospital-based intensive treatment and the continuity of care at home using a
      low-level of telecare (mobile phones). Many treatments delivered using technologies such as
      web-sites, e-mails, chat lines, videoconferences, UMTS-based mobile-phones and telephones)
      could be a valid integration to traditional psychotherapy reducing expensive and
      time-consuming clinical visits and improving adherence to prescribed psychological, dietetic
      and medical treatments through extensive monitoring and support.

      This paper describes the design of the STRATOB study, a two-arm randomized controlled
      clinical trial (RCT). The aims of this study are to compare the effectiveness of the BST with
      the gold standard CBT in a inpatient and telephone-based outpatient program in a sample of
      obese people with BED seeking treatment for weight reduction.
    

Intervention name(s): CBT vs BST
Intervention type(s): Behavioral
Intervention description(s): The comparison between the CBT and BST will be assessed in a two-arm randomized controlled trial. Participants will be randomly allocated in 2 groups (CBT and BST).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Obesity; Binge Eating Disorder; Cognitive Behavioural Therapy; Brief Strategic Therapy; Telepsychology