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

Not Applicable

Completed

• Conditions: Mental Health Issue; Body Image
• Interventions: Behavioral: Cognitive Behavioral Therapy; Procedure: Liposuction

• Registration Number: NCT04199611
• Lead Sponsor: Seoul National University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-10
• Study First Submitted QC: 2019-12-12
• Study First Posted: 2019-12-16
• Study Start: 2020-01-03
• Primary Completion: 2020-08-31
• Study Completion: 2020-12-30
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-20
• Last Update Posted: 2021-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Psychological Therapy Group	Cognitive Behavioral Therapy	This group experiences only cognitive behavioral therapy (CBT; psychological therapy) during the intervention period.
Integrated Therapy Group	Cognitive Behavioral Therapy	Both liposuction and psychological therapy are delivered to the participants in this group.
Integrated Therapy Group	Liposuction	Both liposuction and psychological therapy are delivered to the participants in this group.
Liposuction Group	Liposuction	This group experiences only liposuction and do self-help care after the liposuction.

Primary Outcome Measures

Name	Time	Method
BSQ-8C	4 weeks, 8-item, scale 1 through 6	Body Shape Questionnaire

Secondary Outcome Measures

Name	Time	Method
KoQoL	24 hours, 13-item, scale 1 through 4	Korean version of Obesity-related Quality of Life
K-AAQ-II	24 hours, 10-item, scale 1 through 7	Korean version of The Acceptance and Action Questionnaire - II
fMRI	24 hours	Brain response to the task-based fMRI
K-BDI	24 hours, 21-item, scale 1 through 4	Korean Beck Depression Inventory
RSES	24 hours, 10-item, scale 1 through 4	Rosenberg Self Esteem Scale
PANAS	24 hours, 20-item, scale 1 through 5	Positive and Negative Affect Schedule
Computerized cognitive behavioral task	24 hours	dot-probe task and implicit association task
Cognitive bias on the body image	24 hours, one-item, scale 1 through 4	What do you think about your body image based on the BMI criteria?
Body fat percent	24 hours	the total mass of fat divided by total body mass, multiplied by 100
ALT	24 hours	Alanine transaminase
SCL-90-R	24 hours, 90-item, scale 1 through 5	The Symptom Checklist-90-R
DEBQ	24 hours, 33-item, scale 1 through 5	Dutch Eating Behavioral Questionnaire
TAI	24 hours, 20-item, scale 1 through 4	Trait Anxiety Inventory
BMI in kg/m^2	24 hours	body weight and height
AST	24 hours	Aspartate transaminase
Total Cholesterol	24 hours	blood sample
EAT-26	24 hours, 26-item, scale 1 through 6	The Eating Attitudes Test 26
Waist circumference	24 hours	a measurement taken around the abdomen at the level of the umbilicus.
Leg circumference	24 hours	locating the biggest part of your upper leg
GGT	24 hours	Gamma-glutamyltransferase
Glucose	24 hours	blood sample

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of