Benefits of Group Psychotherapy Programs in the Treatment of Obesity

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03937167
• Other study ID #: PsicoObe
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Obesity
• Psychotherapy
• Psychotherapy, Group

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