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| Name | Class |
|---|---|
| Carlos III Health Institute | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Standard treatment at Hospital Infanta Leonor with Endocrinology and Psyquiatry | |
| Completers | Experimental | Randomized to treatment AND complete treatment 14 sessions are needed |
|
| Drop-out | No Intervention | Randomized to treatment BUT do not assist or do not complete treatment Less than 14 sessions |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psychotherapy group | Other | Added to standard treatment patients will participate in a standardized group of psychological intervention. 21 sessions with 10 to 12 members closed-ended groups. |
| Measure | Description | Time Frame |
|---|---|---|
| weight difference | Difference between the initial and final weight in kilograms | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Global Severity Index (GSI) | Global psychopathology measured by Symptom Checklist-90-Revised (SCL-90-R). T score. | 1 year |
| Positive Symptom Distress Index (PSDI) | Style of response to distress measured by Symptom Checklist-90-Revised (SCL-90-R). T score. |
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Inclusion Criteria:
Non-inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Miriam Félix, PhD | Study Principal Investigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Infanta Leonor | Madrid | 28031 | Spain |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D011615 | Psychotherapy, Group |
| ID | Term |
|---|---|
| D012960 | Socioenvironmental Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| 1 year |
| 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 |
| 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 |
| Physical quality of life | perceived physical quality of life assessed by Quality of Life Cuestionnaire SF-36 | 1 year |
| Mental quality of life | perceived mental or psychic quality of life assessed by Quality of Life Cuestionnaire SF-36 | 1 year |
| Mediterranean Diet Adherence | Mediterranean Diet Adherence measured by Test KIDMED | 1 year |
| 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 |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |