Benefits of Group Psychotherapy Programs in the Treatment of Obesity

Study Overview
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Brief Summary
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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.

Official Title
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Benefits of a Psychotherapy Group Program as Oppossed to the Standard Method in the Treatment of Obesity. A Randomized Controlled Trial.

Conditions
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Obesity, Psychotherapy, Psychotherapy, Group

Intervention / Treatment
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* Other: Psychotherapy group


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Standard treatment at Hospital Infanta Leonor with Endocrinology and Psyquiatry | |
| Experimental: Completers<br>Randomized to treatment AND complete treatment 14 sessions are needed | Other: Psychotherapy group<br>* Added to standard treatment patients will participate in a standardized group of psychological intervention. 21 sessions with 10 to 12 members closed-ended groups.<br>|
| No Intervention: Drop-out<br>Randomized to treatment BUT do not assist or do not complete treatment Less than 14 sessions | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight difference | Difference between the initial and final weight in kilograms | 1 year | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity, Psychotherapy, Psychotherapy Group