Mental Health IssueNCT04199611
Validating Clinical Efficacy for Integrated Psychological Intervention for Obesity: Physical Therapy and Psychotherapy
A study testing Liposuction and Cognitive Behavioral Therapy in people with Mental Health Issue and Body Image, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study is to develop an integrated therapy (physical therapy and psychotherapy) to treat cognitive distortion for body image. Then, validate its efficacy to make an improvement in both physical and mental health. Read more about this study
- Who is it for?
- Ages 20 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mental Health Issue, Body Image
- What is being tested?
- Liposuction and Cognitive Behavioral Therapy
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 Jan 2020to 30 Dec 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 20 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI 25~30
- The score over 68 in SIMS (The situational motivation scale)
Who cannot join
- Diagnosed in any chronic disease
- Trouble using smartphone
- Pregnant or planning to be pregnant
- Unable to be in the fMRI
- Limited to be involved in physical activities over 30 minutes
- already had an experience in liposuction
Trial locations and contacts
1 site in 1 country.
About this study
This study is to develop an integrated therapy (physical therapy and psychotherapy) to treat cognitive distortion for body image. Then, validate its efficacy to make an improvement in both physical and mental health.
- Conditions
- Mental Health Issue, Body Image
- Being tested
- Liposuction, Cognitive Behavioral Therapy
- Keywords
- Body Image Satisfaction, Liposuction, Psychological Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LiposuctionProcedure or surgery
This is a type of fat removal procedure used in plastic surgery.
Cognitive Behavioral TherapyBehavioural
Also called CBT
This is a psycho-social intervention that aims to improve mental health.
| Study group | Role | What they receive |
|---|---|---|
| Integrated Therapy Group | Experimental | Both liposuction and psychological therapy are delivered to the participants in this group. Receives: Procedure: Liposuction; Behavioral: Cognitive Behavioral Therapy |
| Liposuction Group | Active comparator | This group experiences only liposuction and do self-help care after the liposuction. Receives: Procedure: Liposuction |
| Psychological Therapy Group | Active comparator | This group experiences only cognitive behavioral therapy (CBT; psychological therapy) during the intervention period. Receives: Behavioral: Cognitive Behavioral Therapy |
| Self-help Group | No intervention | This group do not receive any interventions and do self-help care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
BSQ-8C
Body Shape Questionnaire
Measured: 4 weeks, 8-item, scale 1 through 6
Secondary outcomes (21)
fMRI
Brain response to the task-based fMRI
Measured: 24 hours
Computerized cognitive behavioral task
dot-probe task and implicit association task
Measured: 24 hours
KoQoL
Korean version of Obesity-related Quality of Life
Measured: 24 hours, 13-item, scale 1 through 4
DEBQ
Dutch Eating Behavioral Questionnaire
Measured: 24 hours, 33-item, scale 1 through 5
K-BDI
Korean Beck Depression Inventory
Measured: 24 hours, 21-item, scale 1 through 4
RSES
Rosenberg Self Esteem Scale
Measured: 24 hours, 10-item, scale 1 through 4
TAI
Trait Anxiety Inventory
Measured: 24 hours, 20-item, scale 1 through 4
PANAS
Positive and Negative Affect Schedule
Measured: 24 hours, 20-item, scale 1 through 5
SCL-90-R
The Symptom Checklist-90-R
Measured: 24 hours, 90-item, scale 1 through 5
EAT-26
The Eating Attitudes Test 26
Measured: 24 hours, 26-item, scale 1 through 6
K-AAQ-II
Korean version of The Acceptance and Action Questionnaire - II
Measured: 24 hours, 10-item, scale 1 through 7
Cognitive bias on the body image
What do you think about your body image based on the BMI criteria?
Measured: 24 hours, one-item, scale 1 through 4
BMI in kg/m^2
body weight and height
Measured: 24 hours
Body fat percent
the total mass of fat divided by total body mass, multiplied by 100
Measured: 24 hours
Leg circumference
locating the biggest part of your upper leg
Measured: 24 hours
Waist circumference
a measurement taken around the abdomen at the level of the umbilicus.
Measured: 24 hours
Glucose
blood sample
Measured: 24 hours
ALT
Alanine transaminase
Measured: 24 hours
AST
Aspartate transaminase
Measured: 24 hours
GGT
Gamma-glutamyltransferase
Measured: 24 hours
Total Cholesterol
blood sample
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2019
- Study start3 Jan 2020
- Primary completion31 Aug 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health IssueStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Global 365MC Hospital
- Responsible party
- Principal investigator, Hyung Jin Choi, Seoul National University Hospital
- Investigators
- Meelim Kim, Study director, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04199611
- Sponsor's protocol ID
- C-1811-124-990
- Status last verified
- Sep 2021
- First submitted
- 10 Dec 2019
- Last updated
- 22 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Clinical Study Report (CSR)
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validating Clinical Efficacy for Integrated Psychological Intervention for Obesity: Physical Therapy and Psychotherapy
- ClinicalTrials.gov ID
- NCT04199611
- Acronym / sponsor ID
- C-1811-124-990
- Conditions
- Mental Health Issue, Body Image
- Keywords
- Body Image Satisfaction, Liposuction, Psychological Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Global 365MC Hospital
- Study start
- 3 Jan 2020 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 16 Dec 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.
This study is to develop an integrated therapy (physical therapy and psychotherapy) to treat cognitive distortion for body image. Then, validate its efficacy to make an improvement in both physical and mental health.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Integrated Therapy Group | Experimental | Procedure: Liposuction, Behavioral: Cognitive Behavioral TherapyBoth liposuction and psychological therapy are delivered to the participants in this group. |
| Liposuction Group | Active comparator | Procedure: LiposuctionThis group experiences only liposuction and do self-help care after the liposuction. |
| Psychological Therapy Group | Active comparator | Behavioral: Cognitive Behavioral TherapyThis group experiences only cognitive behavioral therapy (CBT; psychological therapy) during the intervention period. |
| Self-help Group | No intervention | –This group do not receive any interventions and do self-help care. |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- BMI 25~30
- The score over 68 in SIMS (The situational motivation scale)
Key exclusion criteria (6 listed)
- Diagnosed in any chronic disease
- Trouble using smartphone
- Pregnant or planning to be pregnant
- Unable to be in the fMRI
- Limited to be involved in physical activities over 30 minutes
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 |
|---|---|---|
| LiposuctionThis is a type of fat removal procedure used in plastic surgery. | Procedure or surgery | Integrated Therapy Group, Liposuction Group |
| Cognitive Behavioral TherapyAlso: CBTThis is a psycho-social intervention that aims to improve mental health. | Behavioural | Integrated Therapy Group, Psychological Therapy Group |
Primary outcome
BSQ-8C
Time frame: 4 weeks, 8-item, scale 1 through 6
Body Shape Questionnaire
21 secondary outcomes
fMRI
Time frame: 24 hours
Computerized cognitive behavioral task
Time frame: 24 hours
KoQoL
Time frame: 24 hours, 13-item, scale 1 through 4
DEBQ
Time frame: 24 hours, 33-item, scale 1 through 5
K-BDI
Time frame: 24 hours, 21-item, scale 1 through 4
RSES
Time frame: 24 hours, 10-item, scale 1 through 4
TAI
Time frame: 24 hours, 20-item, scale 1 through 4
PANAS
Time frame: 24 hours, 20-item, scale 1 through 5
SCL-90-R
Time frame: 24 hours, 90-item, scale 1 through 5
EAT-26
Time frame: 24 hours, 26-item, scale 1 through 6
K-AAQ-II
Time frame: 24 hours, 10-item, scale 1 through 7
Cognitive bias on the body image
Time frame: 24 hours, one-item, scale 1 through 4
BMI in kg/m^2
Time frame: 24 hours
Body fat percent
Time frame: 24 hours
Leg circumference
Time frame: 24 hours
Waist circumference
Time frame: 24 hours
Glucose
Time frame: 24 hours
ALT
Time frame: 24 hours
AST
Time frame: 24 hours
GGT
Time frame: 24 hours
Total Cholesterol
Time frame: 24 hours
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 22 Sep 2021.
- Individual participant dataSharing planned: Undecided. Clinical Study Report (CSR)
Related trials for Mental Health Issue
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Active, not recruiting
Digital Therapeutics for Behavior Problems
Problem Behavior, Child Behavior
Recruiting
VOCALE LBD: Online Peer Support for Caregivers of People With Lewy Body Dementia
Lewy Bodies Disease, Depression Disorder
Active, not recruiting
Tailoring CPP for the Foster Care Setting
Behavior Problem
Active, not recruiting
Supporting Health in Veterans With Heart Failure
Heart Failure
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.
Meelim Kim study director
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liposuction and Cognitive Behavioral Therapy in people with Mental Health Issue and Body Image, run by Seoul National University Hospital at 1 site in South Korea.
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 2 inclusion and 6 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 22 Sep 2021. 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 South Korea. 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?
BSQ-8C (time frame: 4 weeks, 8-item, scale 1 through 6). 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 22 Sep 2021.