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Clinical Trials/NCT03766360
NCT03766360
Unknown
Not Applicable

A Social Functioning Intervention to Target Depression Post Bariatric Surgery

University of Washington1 site in 1 country20 target enrollmentJanuary 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Depression
Sponsor
University of Washington
Enrollment
20
Locations
1
Primary Endpoint
Patient Health Questionnaire-9 (PHQ-9)
Last Updated
7 years ago

Overview

Brief Summary

The current study proposes an open clinical trial to investigate the effectiveness of a social functioning intervention on bariatric surgery outcomes and depression. The treatment will be administered in a group format over 10 weekly/biweekly sessions and will take place at the University of Washington Weight Loss Management Clinic (WLMC) at the Roosevelt Clinic location. Effects of the intervention will be measured with self-report questionnaires and by self-report of behaviors outside of assessment sessions (via questionnaires and self-report of adherence to treatment). Data collection will occur at specific time points including before treatment, after treatment, and two months after treatment.

Detailed Description

As of 2009, 344,000 bariatric procedures were performed annually . Although some studies report depressive symptoms decrease in the 6 months after bariatric surgery, there is growing body of literature suggesting there exists a subgroup of patients whose depressive symptoms worsen after surgery and the likelihood of developing depressive symptoms increases longitudinally. Depression can be an indicator of an increased risk of self-harm and additional studies have found that the risk of suicide may increase post bariatric surgery compared to obese individuals who have not undergone surgery. Research supports that psychosocial factors contribute to successful postoperative outcomes. Functional Analytic Psychotherapy shows potential to impact social variables that may be relevant to bariatric surgery outcomes including depression. In this context, FAP aims to improve interpersonal relationships through experientially teaching skills intended to increase social connection. FAP also seeks to increase awareness, which includes the ability to view interpersonal interactions from multiple perspectives, allowing new interpersonal skills to emerge. The present study seeks to evaluate the use of a FAP group to enhance interpersonal relating with a sample of post-bariatric surgery patients. Measures will be collected on quality of life and variables involved in interpersonal connectedness.

Registry
clinicaltrials.gov
Start Date
January 2019
End Date
December 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jonathan Kanter

Associate Professor

University of Washington

Eligibility Criteria

Inclusion Criteria

  • Older than 18
  • Speak English as a primary language
  • Had Bariatric Surgery in the past 6-24 months (bypasses (Roux-en-Y) or sleeves)
  • Yes to one or both of the first two PHQ-9 Questions
  • Not pregnant
  • Not traveling anywhere in the next 6 months
  • No surgeries scheduled in the next 12 months

Exclusion Criteria

  • No exclusion criteria are utilized in the present study.

Outcomes

Primary Outcomes

Patient Health Questionnaire-9 (PHQ-9)

Time Frame: Follow Up (3 Months after Intervention)

based directly on the nine diagnostic criteria for major depressive disorder in the Diagnostic and Statistical Manual Diploma in Social Medicine-IV

Secondary Outcomes

  • World Health Organization Quality of Life(Follow Up (3 Months after Intervention))
  • Drug Abuse Screening Test(Follow Up (3 Months after Intervention))
  • Paffenbarger Physical Activity Questionnaire(Follow Up (3 Months after Intervention))
  • Proximal Change Variables(Follow Up (3 Months after Intervention))
  • Weight Control Questionnaire(Follow Up (3 Months after Intervention))
  • Fear of Intimacy Scale (FIS)(Follow Up (3 Months after Intervention))
  • Social Support Survey(Follow Up (3 Months after Intervention))
  • University of California, Los Angeles Loneliness Scale(Follow Up (3 Months after Intervention))

Study Sites (1)

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