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

Sponsor

Catholic University of the Sacred Heart (Other)

Overall Status

Completed

CT.gov ID

NCT01096251

Collaborator

(none)

100

Enrollment

Arms

114

Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Obesity Binge Eating Disorder	Behavioral: CBT vs BST	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Systemic and STRATegic Psychotherapy for OBesity

Study Start Date :

Jan 1, 2008

Actual Primary Completion Date :

Jul 1, 2017

Actual Study Completion Date :

Jul 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
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).

Arm

Intervention/Treatment

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).

Outcome Measures

Primary Outcome Measures

Psychological wellbeing [6 months]
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) [6 months]
The use of binge days in the week rather than binge episodes relates to the phenomenology of binge eating for patients with BED.