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

Mental Health Issue Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04199611
• Other study ID #: C-1811-124-990
• Status: Completed
• Phase: N/A
• Start date: January 3, 2020
• Est. completion date: December 30, 2020

Study information

• Verified date: September 2021
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: December 30, 2020
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Image
• Mental Health Issue
• Obesity

Intervention

Procedure:
• Liposuction
This is a type of fat removal procedure used in plastic surgery.

Behavioral:
• Cognitive Behavioral Therapy
This is a psycho-social intervention that aims to improve mental health.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Global 365MC Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BSQ-8C	Body Shape Questionnaire	4 weeks, 8-item, scale 1 through 6
Secondary	fMRI	Brain response to the task-based fMRI	24 hours
Secondary	Computerized cognitive behavioral task	dot-probe task and implicit association task	24 hours
Secondary	KoQoL	Korean version of Obesity-related Quality of Life	24 hours, 13-item, scale 1 through 4
Secondary	DEBQ	Dutch Eating Behavioral Questionnaire	24 hours, 33-item, scale 1 through 5
Secondary	K-BDI	Korean Beck Depression Inventory	24 hours, 21-item, scale 1 through 4
Secondary	RSES	Rosenberg Self Esteem Scale	24 hours, 10-item, scale 1 through 4
Secondary	TAI	Trait Anxiety Inventory	24 hours, 20-item, scale 1 through 4
Secondary	PANAS	Positive and Negative Affect Schedule	24 hours, 20-item, scale 1 through 5
Secondary	SCL-90-R	The Symptom Checklist-90-R	24 hours, 90-item, scale 1 through 5
Secondary	EAT-26	The Eating Attitudes Test 26	24 hours, 26-item, scale 1 through 6
Secondary	K-AAQ-II	Korean version of The Acceptance and Action Questionnaire - II	24 hours, 10-item, scale 1 through 7
Secondary	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
Secondary	BMI in kg/m^2	body weight and height	24 hours
Secondary	Body fat percent	the total mass of fat divided by total body mass, multiplied by 100	24 hours
Secondary	Leg circumference	locating the biggest part of your upper leg	24 hours
Secondary	Waist circumference	a measurement taken around the abdomen at the level of the umbilicus.	24 hours
Secondary	Glucose	blood sample	24 hours
Secondary	ALT	Alanine transaminase	24 hours
Secondary	AST	Aspartate transaminase	24 hours
Secondary	GGT	Gamma-glutamyltransferase	24 hours
Secondary	Total Cholesterol	blood sample	24 hours