NCT01096251

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Jan 2008

Longer than P75 for not_applicable obesity

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

March 30, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 31, 2010

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

August 9, 2021

Status Verified

August 1, 2021

Enrollment Period

9.5 years

First QC Date

March 30, 2010

Last Update Submit

August 2, 2021

Conditions

ObesityBinge Eating Disorder

Keywords

ObesityBinge Eating DisorderCognitive Behavioural TherapyBrief Strategic TherapyTelepsychology

Outcome Measures

Primary Outcomes (1)

  • Psychological wellbeing

    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.

    6 months

Secondary Outcomes (1)

  • Number of binge days in the week (assessed by self-report procedures)

    6 months

Study Arms (2)

CBT

EXPERIMENTAL

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

BST

EXPERIMENTAL

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

Interventions

CBT vs BSTBEHAVIORAL

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).

BSTCBT

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • other severe psychiatric disturbance diagnosed by DSM-IV-TR criteria
  • concurrent medical condition not related to obesity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Jackson JB, Pietrabissa G, Rossi A, Manzoni GM, Castelnuovo G. Brief strategic therapy and cognitive behavioral therapy for women with binge eating disorder and comorbid obesity: A randomized clinical trial one-year follow-up. J Consult Clin Psychol. 2018 Aug;86(8):688-701. doi: 10.1037/ccp0000313.

    PMID: 30035585DERIVED

  • Castelnuovo G, Manzoni GM, Villa V, Cesa GL, Pietrabissa G, Molinari E. The STRATOB study: design of a randomized controlled clinical trial of Cognitive Behavioral Therapy and Brief Strategic Therapy with telecare in patients with obesity and binge-eating disorder referred to residential nutritional rehabilitation. Trials. 2011 May 9;12:114. doi: 10.1186/1745-6215-12-114.

    PMID: 21554734DERIVED

MeSH Terms

Conditions

ObesityBinge-Eating Disorder

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsFeeding and Eating DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
prof.

Study Record Dates

First Submitted

March 30, 2010

First Posted

March 31, 2010

Study Start

January 1, 2008

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

August 9, 2021

Record last verified: 2021-08