ObesitySTRATOBNCT01096251
STRATOB: a Randomized Controlled Clinical Trial of Cognitive Behavioural Therapy and Brief Strategic Therapy With Telecare for Binge-eating Disorder
A study testing CBT vs BST in people with Obesity and Binge Eating Disorder, run by Catholic University of the Sacred Heart.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Obesity, Binge Eating Disorder
- What is being tested?
- CBT vs BST
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jan 2008to Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- other severe psychiatric disturbance diagnosed by DSM-IV-TR criteria
- concurrent medical condition not related to obesity.
About this study
Official title: Systemic and STRATegic Psychotherapy for OBesity
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.
Read the 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.
- Conditions
- Obesity, Binge Eating Disorder
- Being tested
- CBT vs BST
- Keywords
- Obesity, Binge Eating Disorder, Cognitive Behavioural Therapy, Brief Strategic Therapy, Telepsychology
- Medical subject headings
- Obesity, Binge-Eating Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT vs BSTBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: CBT vs BST |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
Number of binge days in the week (assessed by self-report procedures)
The use of binge days in the week rather than binge episodes relates to the phenomenology of binge eating for patients with BED.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2010 (estimated)
- Study startJan 2008
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gianluca Castelnuovo, Catholic University of the Sacred Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01096251
- Sponsor's protocol ID
- UCAU-STRATOB-1
- Acronym
- STRATOB
- Status last verified
- Aug 2021
- First submitted
- 30 Mar 2010
- Last updated
- 9 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30035585Castelnuovo 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.
PubMed 21554734
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systemic and STRATegic Psychotherapy for OBesity
- ClinicalTrials.gov ID
- NCT01096251
- Acronym / sponsor ID
- STRATOB / UCAU-STRATOB-1
- Conditions
- Obesity, Binge Eating Disorder
- Keywords
- Obesity, Binge Eating Disorder, Cognitive Behavioural Therapy, Brief Strategic Therapy, Telepsychology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 31 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT | Experimental | Behavioral: CBT vs BSTCBT 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. |
| BST | Experimental | Behavioral: CBT vs BSTBST 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- other severe psychiatric disturbance diagnosed by DSM-IV-TR criteria
- concurrent medical condition not related to obesity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBT vs BSTThe 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). | Behavioural | BST, CBT |
Primary outcome
Psychological wellbeing
Time frame: 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.
1 secondary outcome
Number of binge days in the week (assessed by self-report procedures)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2021.
- Derived from this study: PubMed 30035585Jackson 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.
- Derived from this study: PubMed 21554734Castelnuovo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing CBT vs BST in people with Obesity and Binge Eating Disorder, run by Catholic University of the Sacred Heart.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychological wellbeing (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01096251, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2021.