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STRATOB: a Randomized Controlled Clinical Trial of Cognitive Behavioural Therapy and Brief Strategic Therapy With Telecare for Binge-eating Disorder

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Catholic University of the Sacred Heart.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Compagnia di San Paolo
Information provided by:
Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier:
NCT01096251
First received: March 30, 2010
Last updated: NA
Last verified: March 2010
History: No changes posted
  Purpose

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.


Condition Intervention
Obesity
Binge Eating Disorder
Behavioral: CBT vs BST

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Systemic and STRATegic Psychotherapy for OBesity

Resource links provided by NLM:


Further study details as provided by Catholic University of the Sacred Heart:

Primary Outcome Measures:
  • Psychological wellbeing [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    The Outcome Questionnaire (OQ 45.2) - Italian translation and validation The OQ 45.2 is an self report questionnaire developed by Michael Lambert in 1996. The OQ 45 items version is a measure of outcome and it is designed in order to collect repeated measures of patient progress during psychotherapy and after its conclusion. This instrument is one of the most used in psychotherapy research in the U.S. The OQ 45.2 is composed by 45 items that form 3 scales: Symptom Distress (SD), Interpersonal Relations (IR) e Social Role (SR), and a Global Index.


Secondary Outcome Measures:
  • Number of binge days in the week (assessed by self-report procedures) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    The use of binge days in the week rather than binge episodes relates to the phenomenology of binge eating for patients with BED.


Enrollment: 100
Study Start Date: January 2008
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CBT
CBT group: in-hospital treatment (diet, physical activity, dietitian counseling, 8 sessions of CBT) plus 8 outpatient telephone-based sessions of CBT-oriented psychological support and monitoring with the same CBT inpatient psychotherapists.
Behavioral: CBT vs BST
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).
Experimental: BST
BST group: in-hospital treatment (diet, physical activity, dietitian counseling, 8 sessions of BST) plus 8 outpatient telephone-based sessions of BST-oriented psychological support and monitoring with the same BST inpatient psychotherapists.
Behavioral: CBT vs BST
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).

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. age between 18 and 65 years;
  2. obesity according to the WHO criteria (BMI≥30)
  3. BED (DSM-IV-TR criteria)
  4. written and informed consent to participate

Exclusion Criteria:

  1. other severe psychiatric disturbance diagnosed by DSM-IV-TR criteria
  2. concurrent medical condition not related to obesity.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided by Catholic University of the Sacred Heart

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Gianluca Castelnuovo, PhD., PsyD., Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier: NCT01096251     History of Changes
Other Study ID Numbers: UCAU-STRATOB-1
Study First Received: March 30, 2010
Last Updated: March 30, 2010
Health Authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Keywords provided by Catholic University of the Sacred Heart:
Obesity
Binge Eating Disorder
Cognitive Behavioural Therapy
Brief Strategic Therapy
Telepsychology

Additional relevant MeSH terms:
Binge-Eating Disorder
Bulimia
Disease
Eating Disorders
Obesity
Body Weight
Hyperphagia
Mental Disorders
Nutrition Disorders
Overnutrition
Overweight
Pathologic Processes
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on November 24, 2014