Benefits of Group Psychotherapy Programs in the Treatment of Obesity

NCT ID: NCT03937167

Last Updated: 2022-10-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-01
• Study Completion Date: 2020-06-30

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.

Conditions

Obesity; Psychotherapy; Psychotherapy, Group

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control

Standard treatment at Hospital Infanta Leonor with Endocrinology and Psyquiatry

Group Type: NO_INTERVENTION

No interventions assigned to this group

Completers

Randomized to treatment AND complete treatment 14 sessions are needed

Group Type: EXPERIMENTAL

Psychotherapy group

Intervention Type: 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.

Drop-out

Randomized to treatment BUT do not assist or do not complete treatment Less than 14 sessions

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Carlos III Health Institute

OTHER_GOV

Sponsor Role: collaborator

Hospital Universitario Infanta Leonor

OTHER

Sponsor Role: lead

Responsible Party

Javier Quintero

Psychiatry Department Head

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Miriam Félix, PhD

Role: PRINCIPAL_INVESTIGATOR

Study Principal Investigator

Locations

Hospital Universitario Infanta Leonor

Madrid, , Spain

Countries

Spain

Other Identifiers

PsicoObe

Identifier Type: -

Identifier Source: org_study_id