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NCT Number: NCT03937167

Benefits of Group Psychotherapy Programs in the Treatment of Obesity

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario Infanta Leonor

Madrid, 28031, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Psychotherapy group

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.

Primary outcomes

  1. weight difference

    Time frame: 1 year

    Difference between the initial and final weight in kilograms

Secondary outcomes

  1. Global Severity Index (GSI)

    Time frame: 1 year

    Global psychopathology measured by Symptom Checklist-90-Revised (SCL-90-R). T score.

  2. Positive Symptom Distress Index (PSDI)

    Time frame: 1 year

    Style of response to distress measured by Symptom Checklist-90-Revised (SCL-90-R). T score.

  3. Positive Symptom Total (PST).

    Time frame: 1 year

    count of all the items with non-zero responses at Symptom Checklist-90-Revised (SCL-90-R). T score.

  4. Eating disorder risk (EDRC)

    Time frame: 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

  5. Physical quality of life

    Time frame: 1 year

    perceived physical quality of life assessed by Quality of Life Cuestionnaire SF-36

  6. Mental quality of life

    Time frame: 1 year

    perceived mental or psychic quality of life assessed by Quality of Life Cuestionnaire SF-36

  7. Mediterranean Diet Adherence

    Time frame: 1 year

    Mediterranean Diet Adherence measured by Test KIDMED

  8. Motivation to change

    Time frame: 1 year

    Motivation to change assessed by University of Rhode Island Change Assessment (URICA). 4 scales are measured: precontemplation, contemplation, action and maintenance.

Sponsors and collaborators

Lead sponsor

Hospital Universitario Infanta Leonor

Other

Collaborators

  • Carlos III Health Institute

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
May 3, 2019
Registry last updated
Oct 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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