Validating Clinical Efficacy for Integrated Psychological Intervention for Obesity: Physical Therapy and Psychotherapy

Study Overview
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Brief Summary
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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.

Official Title
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Validating Clinical Efficacy for Integrated Psychological Intervention for Obesity: Physical Therapy and Psychotherapy

Conditions
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Mental Health Issue, Body Image

Intervention / Treatment
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* Procedure: Liposuction
* Behavioral: Cognitive Behavioral Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI 25 30 The score over 68 in SIMS (The situational motivation scale) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Integrated Therapy Group<br>Both liposuction and psychological therapy are delivered to the participants in this group. | Procedure: Liposuction<br>* This is a type of fat removal procedure used in plastic surgery.<br>Behavioral: Cognitive Behavioral Therapy<br>* This is a psycho-social intervention that aims to improve mental health.<br>* Other names: CBT;|
| Active Comparator: Liposuction Group<br>This group experiences only liposuction and do self-help care after the liposuction. | Procedure: Liposuction<br>* This is a type of fat removal procedure used in plastic surgery.<br>|
| Active Comparator: Psychological Therapy Group<br>This group experiences only cognitive behavioral therapy (CBT; psychological therapy) during the intervention period. | Behavioral: Cognitive Behavioral Therapy<br>* This is a psycho-social intervention that aims to improve mental health.<br>* Other names: CBT;|
| No Intervention: Self-help Group<br>This group do not receive any interventions and do self-help care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BSQ-8C | Body Shape Questionnaire | 4 weeks, 8-item, scale 1 through 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fMRI | Brain response to the task-based fMRI | 24 hours | 
| Computerized cognitive behavioral task | dot-probe task and implicit association task | 24 hours | 
| KoQoL | Korean version of Obesity-related Quality of Life | 24 hours, 13-item, scale 1 through 4 | 
| DEBQ | Dutch Eating Behavioral Questionnaire | 24 hours, 33-item, scale 1 through 5 | 
| K-BDI | Korean Beck Depression Inventory | 24 hours, 21-item, scale 1 through 4 | 
| RSES | Rosenberg Self Esteem Scale | 24 hours, 10-item, scale 1 through 4 | 
| TAI | Trait Anxiety Inventory | 24 hours, 20-item, scale 1 through 4 | 
| PANAS | Positive and Negative Affect Schedule | 24 hours, 20-item, scale 1 through 5 | 
| SCL-90-R | The Symptom Checklist-90-R | 24 hours, 90-item, scale 1 through 5 | 
| EAT-26 | The Eating Attitudes Test 26 | 24 hours, 26-item, scale 1 through 6 | 
| K-AAQ-II | Korean version of The Acceptance and Action Questionnaire - II | 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? | 24 hours, one-item, scale 1 through 4 | 
| BMI in kg/m^2 | body weight and height | 24 hours | 
| Body fat percent | the total mass of fat divided by total body mass, multiplied by 100 | 24 hours | 
| Leg circumference | locating the biggest part of your upper leg | 24 hours | 
| Waist circumference | a measurement taken around the abdomen at the level of the umbilicus. | 24 hours | 
| Glucose | blood sample | 24 hours | 
| ALT | Alanine transaminase | 24 hours | 
| AST | Aspartate transaminase | 24 hours | 
| GGT | Gamma-glutamyltransferase | 24 hours | 
| Total Cholesterol | blood sample | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Body Image Satisfaction, Liposuction, Psychological Therapy