GROUP PSYCHOTHERAPY IN OBESITY

Sponsor
Hospital Universitario Infanta Leonor (Other)
Overall Status
Unknown status
CT.gov ID
NCT03937167
Collaborator
Instituto de Salud Carlos III (Other)
180
1
3
33.9
5.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Psychotherapy group
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
180 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
BENEFITS OF A PSYCHOTHERAPY GROUP PROGRAM AS OPPOSED TO THE STANDARD METHOD IN THE TREATMENT OF OBESITY. A RANDOMIZED CONTROLLED TRIAL.
Actual Study Start Date :
Jan 1, 2017
Anticipated Primary Completion Date :
Oct 31, 2019
Anticipated Study Completion Date :
Oct 31, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. weight difference [1 year]

    Difference between the initial and final weight in kilograms

Secondary Outcome Measures

  1. Global Severity Index (GSI) [1 year]

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

  2. Positive Symptom Distress Index (PSDI) [1 year]

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

  3. 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.

  4. 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

  5. Physical quality of life [1 year]

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

  6. Mental quality of life [1 year]

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

  7. Mediterranean Diet Adherence [1 year]

    Mediterranean Diet Adherence measured by Test KIDMED

  8. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital Universitario Infanta Leonor Madrid Spain 28031

Sponsors and Collaborators

  • Hospital Universitario Infanta Leonor
  • Instituto de Salud Carlos III

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Javier Quintero, Psychiatry Department Head, Hospital Universitario Infanta Leonor
ClinicalTrials.gov Identifier:
NCT03937167
Other Study ID Numbers:
  • PsicoObe
First Posted:
May 3, 2019
Last Update Posted:
May 3, 2019
Last Verified:
May 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Javier Quintero, Psychiatry Department Head, Hospital Universitario Infanta Leonor
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 3, 2019