Benefits of Group Psychotherapy Programs in the Treatment of Obesity

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Psychotherapy; Psychotherapy, Group
• Intervention / Treatment: Other: Psychotherapy group

• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28031
    • Hospital Universitario Infanta Leonor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Standard treatment at Hospital Infanta Leonor with Endocrinology and Psyquiatry
Experimental: Completers; Randomized to treatment AND complete treatment 14 sessions are needed	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.
No Intervention: Drop-out; Randomized to treatment BUT do not assist or do not complete treatment Less than 14 sessions

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hospital Universitario Infanta Leonor
• Collaborators: Carlos III Health Institute
• Investigators: Principal Investigator: Miriam Félix, PhD, Study Principal Investigator

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): June 30, 2020

Study Registration Dates

• First Submitted: April 30, 2019
• First Submitted That Met QC Criteria: May 2, 2019
• First Posted (Actual): May 3, 2019

Study Record Updates

• Last Update Posted (Actual): October 19, 2022
• Last Update Submitted That Met QC Criteria: October 17, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: obesity; Psychotherapy; Psychotherapy Group
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: PsicoObe

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No