NCT03937167

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

April 30, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 3, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

October 19, 2022

Status Verified

October 1, 2022

Enrollment Period

3 years

First QC Date

April 30, 2019

Last Update Submit

October 17, 2022

Conditions

ObesityPsychotherapyPsychotherapy, Group

Keywords

obesityPsychotherapyPsychotherapy Group

Outcome Measures

Primary Outcomes (1)

  • weight difference

    Difference between the initial and final weight in kilograms

    1 year

Secondary Outcomes (8)

  • Global Severity Index (GSI)

    1 year

  • Positive Symptom Distress Index (PSDI)

    1 year

  • Positive Symptom Total (PST).

    1 year

  • Eating disorder risk (EDRC)

    1 Year

  • Physical quality of life

    1 year

  • +3 more secondary outcomes

Study Arms (3)

Control

NO INTERVENTION

Standard treatment at Hospital Infanta Leonor with Endocrinology and Psyquiatry

Completers

EXPERIMENTAL

Randomized to treatment AND complete treatment 14 sessions are needed

Other: Psychotherapy group

Drop-out

NO INTERVENTION

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

Interventions

Psychotherapy groupOTHER

Added to standard treatment patients will participate in a standardized group of psychological intervention. 21 sessions with 10 to 12 members closed-ended groups.

Completers

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Pregnancy during treatment
  • Bariatric surgery during treatment
  • Addictive disorder as a principal diagnosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario Infanta Leonor

Madrid, 28031, Spain

Location

MeSH Terms

Conditions

Obesity

Interventions

Psychotherapy, Group

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Socioenvironmental TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Miriam Félix, PhD

    Study Principal Investigator

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Psychiatry Department Head

Study Record Dates

First Submitted

April 30, 2019

First Posted

May 3, 2019

Study Start

January 1, 2017

Primary Completion

December 31, 2019

Study Completion

June 30, 2020

Last Updated

October 19, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)