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Clinical Trials/NCT04199611
NCT04199611
Completed
Not Applicable

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

Seoul National University Hospital1 site in 1 country160 target enrollmentJanuary 3, 2020
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ConditionsMental Health IssueBody Image

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mental Health Issue
Sponsor
Seoul National University Hospital
Enrollment
160
Locations
1
Primary Endpoint
BSQ-8C
Status
Completed
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 3, 2020
End Date
December 30, 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hyung Jin Choi

Professor

Seoul National University Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

BSQ-8C

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

Body Shape Questionnaire

Secondary Outcomes

  • DEBQ(24 hours, 33-item, scale 1 through 5)
  • TAI(24 hours, 20-item, scale 1 through 4)
  • K-AAQ-II(24 hours, 10-item, scale 1 through 7)
  • Computerized cognitive behavioral task(24 hours)
  • fMRI(24 hours)
  • K-BDI(24 hours, 21-item, scale 1 through 4)
  • RSES(24 hours, 10-item, scale 1 through 4)
  • PANAS(24 hours, 20-item, scale 1 through 5)
  • BMI in kg/m^2(24 hours)
  • Cognitive bias on the body image(24 hours, one-item, scale 1 through 4)
  • Body fat percent(24 hours)
  • ALT(24 hours)
  • KoQoL(24 hours, 13-item, scale 1 through 4)
  • SCL-90-R(24 hours, 90-item, scale 1 through 5)
  • AST(24 hours)
  • Total Cholesterol(24 hours)
  • EAT-26(24 hours, 26-item, scale 1 through 6)
  • Waist circumference(24 hours)
  • Leg circumference(24 hours)
  • GGT(24 hours)
  • Glucose(24 hours)

Study Sites (1)

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