ObesityNCT03937167
Benefits of Group Psychotherapy Programs in the Treatment of Obesity
A study testing Psychotherapy group in people with Obesity and Psychotherapy, run by Hospital Universitario Infanta Leonor at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Psychotherapy, Psychotherapy, Group
- What is being tested?
- Psychotherapy group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2017to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 12Show fewer
- 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.
Who cannot join
- Pregnancy during treatment
- Bariatric surgery during treatment
- Addictive disorder as a principal diagnosis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Benefits of a Psychotherapy Group Program as Oppossed to the Standard Method in the Treatment of Obesity. A Randomized Controlled Trial.
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.
- Conditions
- Obesity, Psychotherapy, Psychotherapy, Group
- Being tested
- Psychotherapy group
- Keywords
- obesity, Psychotherapy, Psychotherapy Group
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Psychotherapy group |
| Drop-out | No intervention | Randomized to treatment BUT do not assist or do not complete treatment Less than 14 sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight difference
Difference between the initial and final weight in kilograms
Measured: 1 year
Secondary outcomes (8)
Global Severity Index (GSI)
Global psychopathology measured by Symptom Checklist-90-Revised (SCL-90-R). T score.
Measured: 1 year
Positive Symptom Distress Index (PSDI)
Style of response to distress measured by Symptom Checklist-90-Revised (SCL-90-R). T score.
Measured: 1 year
Positive Symptom Total (PST).
count of all the items with non-zero responses at Symptom Checklist-90-Revised (SCL-90-R). T score.
Measured: 1 year
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
Measured: 1 Year
Physical quality of life
perceived physical quality of life assessed by Quality of Life Cuestionnaire SF-36
Measured: 1 year
Mental quality of life
perceived mental or psychic quality of life assessed by Quality of Life Cuestionnaire SF-36
Measured: 1 year
Mediterranean Diet Adherence
Mediterranean Diet Adherence measured by Test KIDMED
Measured: 1 year
Motivation to change
Motivation to change assessed by University of Rhode Island Change Assessment (URICA). 4 scales are measured: precontemplation, contemplation, action and maintenance.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2019
- Study start1 Jan 2017
- Primary completion31 Dec 2019
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Infanta Leonor
- Sponsor type
- University, hospital or other
- Collaborators
- Carlos III Health Institute
- Responsible party
- Principal investigator, Javier Quintero, Hospital Universitario Infanta Leonor
- Investigators
- Miriam Félix, PhD, Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03937167
- Sponsor's protocol ID
- PsicoObe
- Status last verified
- Oct 2022
- First submitted
- 30 Apr 2019
- Last updated
- 19 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefits of a Psychotherapy Group Program as Oppossed to the Standard Method in the Treatment of Obesity. A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT03937167
- Acronym / sponsor ID
- PsicoObe
- Conditions
- Obesity, Psychotherapy, Psychotherapy, Group
- Keywords
- obesity, Psychotherapy, Psychotherapy Group
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Hospital Universitario Infanta LeonorUniversity, hospital or other
- Collaborators
- Carlos III Health Institute
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 3 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Standard treatment at Hospital Infanta Leonor with Endocrinology and Psyquiatry |
| Completers | Experimental | Other: Psychotherapy groupRandomized to treatment AND complete treatment 14 sessions are needed |
| Drop-out | No intervention | –Randomized to treatment BUT do not assist or do not complete treatment Less than 14 sessions |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (3 listed)
- Pregnancy during treatment
- Bariatric surgery during treatment
- Addictive disorder as a principal diagnosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychotherapy groupAdded to standard treatment patients will participate in a standardized group of psychological intervention. 21 sessions with 10 to 12 members closed-ended groups. | Other | Completers |
Primary outcome
weight difference
Time frame: 1 year
Difference between the initial and final weight in kilograms
8 secondary outcomes
Global Severity Index (GSI)
Time frame: 1 year
Positive Symptom Distress Index (PSDI)
Time frame: 1 year
Positive Symptom Total (PST).
Time frame: 1 year
Eating disorder risk (EDRC)
Time frame: 1 Year
Physical quality of life
Time frame: 1 year
Mental quality of life
Time frame: 1 year
Mediterranean Diet Adherence
Time frame: 1 year
Motivation to change
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miriam Félix, PhD principal investigator
Study Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychotherapy group in people with Obesity and Psychotherapy, run by Hospital Universitario Infanta Leonor at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
weight difference (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2022; AzTrials last refreshed its copy on 8 Nov 2026.