Clinical trial NCT03937167: Benefits of Group Psychotherapy Programs in the Treatment of Obesity
Official title: Benefits of a Psychotherapy Group Program as Oppossed to the Standard Method in the Treatment of Obesity. A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Psychotherapy
Psychotherapy, Group
Keywords: obesity
Psychotherapy
Psychotherapy Group
Lead sponsor: Hospital Universitario Infanta Leonor
Sponsor class: OTHER
Collaborators: name: Carlos III Health Institute
First posted: 2019-05-03
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

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.

Primary outcomes:
measure: weight difference
timeFrame: 1 year
Secondary outcomes:
measure: Global Severity Index (GSI)
timeFrame: 1 year
measure: Positive Symptom Distress Index (PSDI)
timeFrame: 1 year
measure: Positive Symptom Total (PST).
timeFrame: 1 year
measure: Eating disorder risk (EDRC)
timeFrame: 1 Year
measure: Physical quality of life
timeFrame: 1 year
measure: Mental quality of life
timeFrame: 1 year
measure: Mediterranean Diet Adherence
timeFrame: 1 year
measure: Motivation to change
timeFrame: 1 year
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Leonor
Study officials:
affiliation: Study Principal Investigator
name: Miriam Félix, PhD
role: PRINCIPAL_INVESTIGATOR
References: