Bariatric Surgery Study (SIBS)
Primary Purpose
Depression, Quality of Life, Interpersonal Relations
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Functional Analytical Psychotherapy (FAP)
Sponsored by
About this trial
This is an interventional supportive care trial for Depression
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.
Sites / Locations
- Weight Loss Management Center at UWMC-Roosevelt
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
FAP Intervention Group
Control Group
Arm Description
All of the clients in the FAP intervention group will begin treatment at the same time and complete 3 assessments.
The clients in the control group will take their assessments at the same time as those in the FAP intervention group.
Outcomes
Primary Outcome Measures
Patient Health Questionnaire-9 (PHQ-9)
based directly on the nine diagnostic criteria for major depressive disorder in the Diagnostic and Statistical Manual Diploma in Social Medicine-IV
Patient Health Questionnaire-9 (PHQ-9)
based directly on the nine diagnostic criteria for major depressive disorder in the Diagnostic and Statistical Manual Diploma in Social Medicine-IV
Patient Health Questionnaire-9 (PHQ-9)
based directly on the nine diagnostic criteria for major depressive disorder in the Diagnostic and Statistical Manual Diploma in Social Medicine-IV
Secondary Outcome Measures
World Health Organization Quality of Life
a measure of an individual's physical health, psychological state, personal beliefs, social relationships and their relationship to salient features of their environment.
World Health Organization Quality of Life
a measure of an individual's physical health, psychological state, personal beliefs, social relationships and their relationship to salient features of their environment.
World Health Organization Quality of Life
a measure of an individual's physical health, psychological state, personal beliefs, social relationships and their relationship to salient features of their environment.
Drug Abuse Screening Test
a sensitive screening instrument for the abuse of drugs other than alcohol
Drug Abuse Screening Test
a sensitive screening instrument for the abuse of drugs other than alcohol
Drug Abuse Screening Test
a sensitive screening instrument for the abuse of drugs other than alcohol
Paffenbarger Physical Activity Questionnaire
asks participants about their current and previous exercise habits
Paffenbarger Physical Activity Questionnaire
asks participants about their current and previous exercise habits
Paffenbarger Physical Activity Questionnaire
asks participants about their current and previous exercise habits
Proximal Change Variables
assesses participant's eating habits as well as tobacco and alcohol use
Proximal Change Variables
assesses participant's eating habits as well as tobacco and alcohol use
Proximal Change Variables
assesses participant's eating habits as well as tobacco and alcohol use
Weight Control Questionnaire
asks participants to report if they have ever used any weight control practices
Weight Control Questionnaire
asks participants to report if they have ever used any weight control practices
Weight Control Questionnaire
asks participants to report if they have ever used any weight control practices
Fear of Intimacy Scale (FIS)
The FIS is a 35 item measure of self-disclosure, social intimacy, and social desirability. All items are scored on a 5-point Likert scale
Fear of Intimacy Scale (FIS)
The FIS is a 35 item measure of self-disclosure, social intimacy, and social desirability. All items are scored on a 5-point Likert scale
Fear of Intimacy Scale (FIS)
The FIS is a 35 item measure of self-disclosure, social intimacy, and social desirability. All items are scored on a 5-point Likert scale
Social Support Survey
provides an assessment of several domains of social support including tangible support, emotional support, affective support, and positive support
Social Support Survey
provides an assessment of several domains of social support including tangible support, emotional support, affective support, and positive support
Social Support Survey
provides an assessment of several domains of social support including tangible support, emotional support, affective support, and positive support
University of California, Los Angeles Loneliness Scale
designed to measure one's subjective feelings of loneliness as well as feelings of social isolation
University of California, Los Angeles Loneliness Scale
designed to measure one's subjective feelings of loneliness as well as feelings of social isolation
University of California, Los Angeles Loneliness Scale
designed to measure one's subjective feelings of loneliness as well as feelings of social isolation
Full Information
NCT ID
NCT03766360
First Posted
November 27, 2018
Last Updated
December 4, 2018
Sponsor
University of Washington
1. Study Identification
Unique Protocol Identification Number
NCT03766360
Brief Title
Bariatric Surgery Study
Acronym
SIBS
Official Title
A Social Functioning Intervention to Target Depression Post Bariatric Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 2019 (Anticipated)
Primary Completion Date
June 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Quality of Life, Interpersonal Relations
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
FAP Intervention Group
Arm Type
Experimental
Arm Description
All of the clients in the FAP intervention group will begin treatment at the same time and complete 3 assessments.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
The clients in the control group will take their assessments at the same time as those in the FAP intervention group.
Intervention Type
Behavioral
Intervention Name(s)
Functional Analytical Psychotherapy (FAP)
Intervention Description
The intervention itself is based on the procedures of Functional Analytic Psychotherapy, a behavioral intervention focusing on improving social functioning.
Primary Outcome Measure Information:
Title
Patient Health Questionnaire-9 (PHQ-9)
Description
based directly on the nine diagnostic criteria for major depressive disorder in the Diagnostic and Statistical Manual Diploma in Social Medicine-IV
Time Frame
Baseline
Title
Patient Health Questionnaire-9 (PHQ-9)
Description
based directly on the nine diagnostic criteria for major depressive disorder in the Diagnostic and Statistical Manual Diploma in Social Medicine-IV
Time Frame
Post Intervention (Approximately 12 Weeks from Baseline)
Title
Patient Health Questionnaire-9 (PHQ-9)
Description
based directly on the nine diagnostic criteria for major depressive disorder in the Diagnostic and Statistical Manual Diploma in Social Medicine-IV
Time Frame
Follow Up (3 Months after Intervention)
Secondary Outcome Measure Information:
Title
World Health Organization Quality of Life
Description
a measure of an individual's physical health, psychological state, personal beliefs, social relationships and their relationship to salient features of their environment.
Time Frame
Baseline
Title
World Health Organization Quality of Life
Description
a measure of an individual's physical health, psychological state, personal beliefs, social relationships and their relationship to salient features of their environment.
Time Frame
Post Intervention (Approximately 12 Weeks from Baseline)
Title
World Health Organization Quality of Life
Description
a measure of an individual's physical health, psychological state, personal beliefs, social relationships and their relationship to salient features of their environment.
Time Frame
Follow Up (3 Months after Intervention)
Title
Drug Abuse Screening Test
Description
a sensitive screening instrument for the abuse of drugs other than alcohol
Time Frame
Baseline
Title
Drug Abuse Screening Test
Description
a sensitive screening instrument for the abuse of drugs other than alcohol
Time Frame
Post Intervention (Approximately 12 Weeks from Baseline)
Title
Drug Abuse Screening Test
Description
a sensitive screening instrument for the abuse of drugs other than alcohol
Time Frame
Follow Up (3 Months after Intervention)
Title
Paffenbarger Physical Activity Questionnaire
Description
asks participants about their current and previous exercise habits
Time Frame
Baseline
Title
Paffenbarger Physical Activity Questionnaire
Description
asks participants about their current and previous exercise habits
Time Frame
Post Intervention (Approximately 12 Weeks from Baseline)
Title
Paffenbarger Physical Activity Questionnaire
Description
asks participants about their current and previous exercise habits
Time Frame
Follow Up (3 Months after Intervention)
Title
Proximal Change Variables
Description
assesses participant's eating habits as well as tobacco and alcohol use
Time Frame
Baseline
Title
Proximal Change Variables
Description
assesses participant's eating habits as well as tobacco and alcohol use
Time Frame
Post Intervention (Approximately 12 Weeks from Baseline)
Title
Proximal Change Variables
Description
assesses participant's eating habits as well as tobacco and alcohol use
Time Frame
Follow Up (3 Months after Intervention)
Title
Weight Control Questionnaire
Description
asks participants to report if they have ever used any weight control practices
Time Frame
Baseline
Title
Weight Control Questionnaire
Description
asks participants to report if they have ever used any weight control practices
Time Frame
Post Intervention (Approximately 12 Weeks from Baseline)
Title
Weight Control Questionnaire
Description
asks participants to report if they have ever used any weight control practices
Time Frame
Follow Up (3 Months after Intervention)
Title
Fear of Intimacy Scale (FIS)
Description
The FIS is a 35 item measure of self-disclosure, social intimacy, and social desirability. All items are scored on a 5-point Likert scale
Time Frame
Baseline
Title
Fear of Intimacy Scale (FIS)
Description
The FIS is a 35 item measure of self-disclosure, social intimacy, and social desirability. All items are scored on a 5-point Likert scale
Time Frame
Post Intervention (Approximately 12 Weeks from Baseline)
Title
Fear of Intimacy Scale (FIS)
Description
The FIS is a 35 item measure of self-disclosure, social intimacy, and social desirability. All items are scored on a 5-point Likert scale
Time Frame
Follow Up (3 Months after Intervention)
Title
Social Support Survey
Description
provides an assessment of several domains of social support including tangible support, emotional support, affective support, and positive support
Time Frame
Baseline
Title
Social Support Survey
Description
provides an assessment of several domains of social support including tangible support, emotional support, affective support, and positive support
Time Frame
Post Intervention (Approximately 12 Weeks from Baseline)
Title
Social Support Survey
Description
provides an assessment of several domains of social support including tangible support, emotional support, affective support, and positive support
Time Frame
Follow Up (3 Months after Intervention)
Title
University of California, Los Angeles Loneliness Scale
Description
designed to measure one's subjective feelings of loneliness as well as feelings of social isolation
Time Frame
Baseline
Title
University of California, Los Angeles Loneliness Scale
Description
designed to measure one's subjective feelings of loneliness as well as feelings of social isolation
Time Frame
Post Intervention (Approximately 12 Weeks from Baseline)
Title
University of California, Los Angeles Loneliness Scale
Description
designed to measure one's subjective feelings of loneliness as well as feelings of social isolation
Time Frame
Follow Up (3 Months after Intervention)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jonathan Kanter, PhD
Phone
206-685-7462
Email
jonkan@uw.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Elliot Wallace
Phone
206-685-7462
Email
elliotcw@uw.edu
Facility Information:
Facility Name
Weight Loss Management Center at UWMC-Roosevelt
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruth Foster-Koth, MA
Phone
206-598-1752
Email
rfosterk@uw.edu
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
19272486
Citation
Buchwald H, Estok R, Fahrbach K, Banel D, Jensen MD, Pories WJ, Bantle JP, Sledge I. Weight and type 2 diabetes after bariatric surgery: systematic review and meta-analysis. Am J Med. 2009 Mar;122(3):248-256.e5. doi: 10.1016/j.amjmed.2008.09.041.
Results Reference
background
Citation
Switzer, N.J., Debru, E., Church, N. et al. Curr Cardiovasc Risk Rep (2016) 10: 12. https://doi.org/10.1007/s12170-016-0492-7
Results Reference
background
PubMed Identifier
23404774
Citation
Mitchell JE, Crosby R, de Zwaan M, Engel S, Roerig J, Steffen K, Gordon KH, Karr T, Lavender J, Wonderlich S. Possible risk factors for increased suicide following bariatric surgery. Obesity (Silver Spring). 2013 Apr;21(4):665-72. doi: 10.1002/oby.20066.
Results Reference
background
PubMed Identifier
22551576
Citation
Sarwer DB, Moore RH, Spitzer JC, Wadden TA, Raper SE, Williams NN. A pilot study investigating the efficacy of postoperative dietary counseling to improve outcomes after bariatric surgery. Surg Obes Relat Dis. 2012 Sep-Oct;8(5):561-8. doi: 10.1016/j.soard.2012.02.010. Epub 2012 Mar 21.
Results Reference
background
Citation
Kohlenberg, R. J., & Tsai, M. (1991). Functional analytic psychotherapy: Creating intense and curative therapeutic relationships. New York, NY, US: Plenum Press. http://dx.doi.org/10.1007/978-0-387-70855-3
Results Reference
background
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Bariatric Surgery Study
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