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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03937167
Other study ID # PsicoObe
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2017
Est. completion date June 30, 2020

Study information

Verified date October 2022
Source Hospital Universitario Infanta Leonor
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Obesity has reached pandemic proportions in recent years, affecting not only the physical health, but also the mental health, of obese people. According to Spain's National Health Survey 2011-12, the prevalence of obesity in the adult population of Spain was 17%, having increased by 2.5% since 2006. Therefore, a constant and worrying increase in the prevalence of obesity is being observed, which is having a great impact, both individually, in terms of health and quality of life, and socially, inter alia, by raising health expenditure due to increased morbidity. In this context, the desirability of a comprehensive approach that includes psychological intervention in attending obese patients (Rev Cochrane, 2006), has been given greater prominence. Paying attention to the emotional and psychopathological aspects related to obesity has proven to be an action that could have positive impact on obesity intervention models. The aim of this project is to measure, through a clinical trial, the efficacy of a psychotherapy group program for obesity patients who are attended by the consulting endocrinologist at the Infanta Leonor Hospital (Madrid). The impact of body mass index, psychological wellbeing, psychopathology and quality of life of two experimental study groups will be compared, one a control group of patients that follows the standard treatment, the other an experimental group that follows not only the standard treatment, but also the psychotherapy group intervention program.


Recruitment information / eligibility

Status Completed
Enrollment 180
Est. completion date June 30, 2020
Est. primary completion date December 31, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Age older than 18 and younger than 65. - Body mass index of 30 or higher. - Candidate to a specific obesity treatment. - Accept psychological attention. - Able to understand and consent participation. - Able to speak, write and read in Spanish. - Committed to assist weekly for 6 months Non-inclusion Criteria: - Obesity related to a non- stabilized hormonal disorder. - Severe mental disorders requiring specific treatment resources. - Cognitive or sensitive deficits. - Having had bariatric surgery within last 2 years. Exclusion criteria: - Pregnancy during treatment - Bariatric surgery during treatment - Addictive disorder as a principal diagnosis.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Psychotherapy group
Added to standard treatment patients will participate in a standardized group of psychological intervention. 21 sessions with 10 to 12 members closed-ended groups.

Locations

Country Name City State
Spain Hospital Universitario Infanta Leonor Madrid

Sponsors (2)

Lead Sponsor Collaborator
Hospital Universitario Infanta Leonor Carlos III Health Institute

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary weight difference Difference between the initial and final weight in kilograms 1 year
Secondary Global Severity Index (GSI) Global psychopathology measured by Symptom Checklist-90-Revised (SCL-90-R). T score. 1 year
Secondary Positive Symptom Distress Index (PSDI) Style of response to distress measured by Symptom Checklist-90-Revised (SCL-90-R). T score. 1 year
Secondary Positive Symptom Total (PST). count of all the items with non-zero responses at Symptom Checklist-90-Revised (SCL-90-R). T score. 1 year
Secondary Eating disorder risk (EDRC) disfunctional eating behavior assessed by Eating Disorders Inventory 3rd Edition (EDI-3). T score. It is an index calculated by combining 3 scales: drive for thinness, body dissatisfaction, and bulimia 1 Year
Secondary Physical quality of life perceived physical quality of life assessed by Quality of Life Cuestionnaire SF-36 1 year
Secondary Mental quality of life perceived mental or psychic quality of life assessed by Quality of Life Cuestionnaire SF-36 1 year
Secondary Mediterranean Diet Adherence Mediterranean Diet Adherence measured by Test KIDMED 1 year
Secondary Motivation to change Motivation to change assessed by University of Rhode Island Change Assessment (URICA). 4 scales are measured: precontemplation, contemplation, action and maintenance. 1 year
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