Benefits of Group Psychotherapy Programs in the Treatment of Obesity

Not Applicable

Completed

• Conditions: Obesity; Psychotherapy; Psychotherapy, Group
• Interventions: Other: Psychotherapy group

• Registration Number: NCT03937167
• Lead Sponsor: Hospital Universitario Infanta Leonor

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-01
• Study First Submitted: 2019-04-30
• Study First Submitted QC: 2019-05-02
• Study First Posted: 2019-05-03
• Primary Completion: 2019-12-31
• Study Completion: 2020-06-30
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-17
• Last Update Posted: 2022-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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.

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Completers	Psychotherapy group	Randomized to treatment AND complete treatment 14 sessions are needed

Primary Outcome Measures

Name	Time	Method
weight difference	1 year	Difference between the initial and final weight in kilograms

Secondary Outcome Measures

Name	Time	Method
Eating disorder risk (EDRC)	1 Year	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
Physical quality of life	1 year	perceived physical quality of life assessed by Quality of Life Cuestionnaire SF-36
Positive Symptom Total (PST).	1 year	count of all the items with non-zero responses at Symptom Checklist-90-Revised (SCL-90-R). T score.
Motivation to change	1 year	Motivation to change assessed by University of Rhode Island Change Assessment (URICA). 4 scales are measured: precontemplation, contemplation, action and maintenance.
Global Severity Index (GSI)	1 year	Global psychopathology measured by Symptom Checklist-90-Revised (SCL-90-R). T score.
Positive Symptom Distress Index (PSDI)	1 year	Style of response to distress measured by Symptom Checklist-90-Revised (SCL-90-R). T score.
Mental quality of life	1 year	perceived mental or psychic quality of life assessed by Quality of Life Cuestionnaire SF-36
Mediterranean Diet Adherence	1 year	Mediterranean Diet Adherence measured by Test KIDMED

Trial Locations

Locations (1)

Hospital Universitario Infanta Leonor; 🇪🇸 Madrid, Spain