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Completed

NCT Number: NCT04199611

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

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.

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Key information

Conditions

Mental Health Issue Body Image

Age range

20 year–30 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Liposuction

Procedure

This is a type of fat removal procedure used in plastic surgery.

Cognitive behavioral therapy

Behavioral

This is a psycho-social intervention that aims to improve mental health.

Other names: CBT

Primary outcomes

  1. BSQ-8C

    Time frame: 4 weeks, 8-item, scale 1 through 6

    Body Shape Questionnaire

Secondary outcomes

  1. fMRI

    Time frame: 24 hours

    Brain response to the task-based fMRI

  2. Computerized cognitive behavioral task

    Time frame: 24 hours

    dot-probe task and implicit association task

  3. KoQoL

    Time frame: 24 hours, 13-item, scale 1 through 4

    Korean version of Obesity-related Quality of Life

  4. DEBQ

    Time frame: 24 hours, 33-item, scale 1 through 5

    Dutch Eating Behavioral Questionnaire

  5. K-BDI

    Time frame: 24 hours, 21-item, scale 1 through 4

    Korean Beck Depression Inventory

  6. RSES

    Time frame: 24 hours, 10-item, scale 1 through 4

    Rosenberg Self Esteem Scale

  7. TAI

    Time frame: 24 hours, 20-item, scale 1 through 4

    Trait Anxiety Inventory

  8. PANAS

    Time frame: 24 hours, 20-item, scale 1 through 5

    Positive and Negative Affect Schedule

  9. SCL-90-R

    Time frame: 24 hours, 90-item, scale 1 through 5

    The Symptom Checklist-90-R

  10. EAT-26

    Time frame: 24 hours, 26-item, scale 1 through 6

    The Eating Attitudes Test 26

  11. K-AAQ-II

    Time frame: 24 hours, 10-item, scale 1 through 7

    Korean version of The Acceptance and Action Questionnaire - II

  12. Cognitive bias on the body image

    Time frame: 24 hours, one-item, scale 1 through 4

    What do you think about your body image based on the BMI criteria?

  13. BMI in kg/m^2

    Time frame: 24 hours

    body weight and height

  14. Body fat percent

    Time frame: 24 hours

    the total mass of fat divided by total body mass, multiplied by 100

  15. Leg circumference

    Time frame: 24 hours

    locating the biggest part of your upper leg

  16. Waist circumference

    Time frame: 24 hours

    a measurement taken around the abdomen at the level of the umbilicus.

  17. Glucose

    Time frame: 24 hours

    blood sample

  18. ALT

    Time frame: 24 hours

    Alanine transaminase

  19. AST

    Time frame: 24 hours

    Aspartate transaminase

  20. GGT

    Time frame: 24 hours

    Gamma-glutamyltransferase

  21. Total Cholesterol

    Time frame: 24 hours

    blood sample

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Global 365MC Hospital

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Dec 16, 2019
Registry last updated
Sep 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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