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Benefits of Group Psychotherapy Programs in the Treatment of Obesity

Primary Purpose

Obesity, Psychotherapy, Psychotherapy, Group

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Psychotherapy group
Sponsored by
Hospital Universitario Infanta Leonor
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring obesity, Psychotherapy, Psychotherapy Group

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Universitario Infanta Leonor

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

No Intervention

Arm Label

Control

Completers

Drop-out

Arm Description

Standard treatment at Hospital Infanta Leonor with Endocrinology and Psyquiatry

Randomized to treatment AND complete treatment 14 sessions are needed

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

Outcomes

Primary Outcome Measures

weight difference
Difference between the initial and final weight in kilograms

Secondary Outcome Measures

Global Severity Index (GSI)
Global psychopathology measured by Symptom Checklist-90-Revised (SCL-90-R). T score.
Positive Symptom Distress Index (PSDI)
Style of response to distress measured by Symptom Checklist-90-Revised (SCL-90-R). T score.
Positive Symptom Total (PST).
count of all the items with non-zero responses at Symptom Checklist-90-Revised (SCL-90-R). T score.
Eating disorder risk (EDRC)
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
Physical quality of life
perceived physical quality of life assessed by Quality of Life Cuestionnaire SF-36
Mental quality of life
perceived mental or psychic quality of life assessed by Quality of Life Cuestionnaire SF-36
Mediterranean Diet Adherence
Mediterranean Diet Adherence measured by Test KIDMED
Motivation to change
Motivation to change assessed by University of Rhode Island Change Assessment (URICA). 4 scales are measured: precontemplation, contemplation, action and maintenance.

Full Information

First Posted
April 30, 2019
Last Updated
October 17, 2022
Sponsor
Hospital Universitario Infanta Leonor
Collaborators
Carlos III Health Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03937167
Brief Title
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

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
June 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitario Infanta Leonor
Collaborators
Carlos III Health Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Psychotherapy, Psychotherapy, Group
Keywords
obesity, Psychotherapy, Psychotherapy Group

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard treatment at Hospital Infanta Leonor with Endocrinology and Psyquiatry
Arm Title
Completers
Arm Type
Experimental
Arm Description
Randomized to treatment AND complete treatment 14 sessions are needed
Arm Title
Drop-out
Arm Type
No Intervention
Arm Description
Randomized to treatment BUT do not assist or do not complete treatment Less than 14 sessions
Intervention Type
Other
Intervention Name(s)
Psychotherapy group
Intervention Description
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 Outcome Measure Information:
Title
weight difference
Description
Difference between the initial and final weight in kilograms
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Global Severity Index (GSI)
Description
Global psychopathology measured by Symptom Checklist-90-Revised (SCL-90-R). T score.
Time Frame
1 year
Title
Positive Symptom Distress Index (PSDI)
Description
Style of response to distress measured by Symptom Checklist-90-Revised (SCL-90-R). T score.
Time Frame
1 year
Title
Positive Symptom Total (PST).
Description
count of all the items with non-zero responses at Symptom Checklist-90-Revised (SCL-90-R). T score.
Time Frame
1 year
Title
Eating disorder risk (EDRC)
Description
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
Time Frame
1 Year
Title
Physical quality of life
Description
perceived physical quality of life assessed by Quality of Life Cuestionnaire SF-36
Time Frame
1 year
Title
Mental quality of life
Description
perceived mental or psychic quality of life assessed by Quality of Life Cuestionnaire SF-36
Time Frame
1 year
Title
Mediterranean Diet Adherence
Description
Mediterranean Diet Adherence measured by Test KIDMED
Time Frame
1 year
Title
Motivation to change
Description
Motivation to change assessed by University of Rhode Island Change Assessment (URICA). 4 scales are measured: precontemplation, contemplation, action and maintenance.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miriam Félix, PhD
Organizational Affiliation
Study Principal Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario Infanta Leonor
City
Madrid
ZIP/Postal Code
28031
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Benefits of Group Psychotherapy Programs in the Treatment of Obesity

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