Bariatric Surgery Study (SIBS)

A Social Functioning Intervention to Target Depression Post Bariatric Surgery

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.

Study Overview

• Status: Unknown
• Conditions: Depression; Quality of Life; Interpersonal Relations
• Intervention / Treatment: Behavioral: Functional Analytical Psychotherapy (FAP)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jonathan Kanter, PhD; Phone Number: 206-685-7462; Email: jonkan@uw.edu
• Study Contact Backup: Name: Elliot Wallace; Phone Number: 206-685-7462; Email: elliotcw@uw.edu

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98105
      • Weight Loss Management Center at UWMC-Roosevelt
      • Contact: Ruth Foster-Koth, MA; Phone Number: 206-598-1752; Email: rfosterk@uw.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FAP Intervention Group; All of the clients in the FAP intervention group will begin treatment at the same time and complete 3 assessments.	Behavioral: Functional Analytical Psychotherapy (FAP); The intervention itself is based on the procedures of Functional Analytic Psychotherapy, a behavioral intervention focusing on improving social functioning.
No Intervention: Control Group; The clients in the control group will take their assessments at the same time as those in the FAP intervention group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline
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	Post Intervention (Approximately 12 Weeks from Baseline)
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	Follow Up (3 Months after Intervention)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline
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.	Post Intervention (Approximately 12 Weeks from Baseline)
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.	Follow Up (3 Months after Intervention)
Drug Abuse Screening Test	a sensitive screening instrument for the abuse of drugs other than alcohol	Baseline
Drug Abuse Screening Test	a sensitive screening instrument for the abuse of drugs other than alcohol	Post Intervention (Approximately 12 Weeks from Baseline)
Drug Abuse Screening Test	a sensitive screening instrument for the abuse of drugs other than alcohol	Follow Up (3 Months after Intervention)
Paffenbarger Physical Activity Questionnaire	asks participants about their current and previous exercise habits	Baseline
Paffenbarger Physical Activity Questionnaire	asks participants about their current and previous exercise habits	Post Intervention (Approximately 12 Weeks from Baseline)
Paffenbarger Physical Activity Questionnaire	asks participants about their current and previous exercise habits	Follow Up (3 Months after Intervention)
Proximal Change Variables	assesses participant's eating habits as well as tobacco and alcohol use	Baseline
Proximal Change Variables	assesses participant's eating habits as well as tobacco and alcohol use	Post Intervention (Approximately 12 Weeks from Baseline)
Proximal Change Variables	assesses participant's eating habits as well as tobacco and alcohol use	Follow Up (3 Months after Intervention)
Weight Control Questionnaire	asks participants to report if they have ever used any weight control practices	Baseline
Weight Control Questionnaire	asks participants to report if they have ever used any weight control practices	Post Intervention (Approximately 12 Weeks from Baseline)
Weight Control Questionnaire	asks participants to report if they have ever used any weight control practices	Follow Up (3 Months after Intervention)
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	Baseline
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	Post Intervention (Approximately 12 Weeks from Baseline)
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	Follow Up (3 Months after Intervention)
Social Support Survey	provides an assessment of several domains of social support including tangible support, emotional support, affective support, and positive support	Baseline
Social Support Survey	provides an assessment of several domains of social support including tangible support, emotional support, affective support, and positive support	Post Intervention (Approximately 12 Weeks from Baseline)
Social Support Survey	provides an assessment of several domains of social support including tangible support, emotional support, affective support, and positive support	Follow Up (3 Months after Intervention)
University of California, Los Angeles Loneliness Scale	designed to measure one's subjective feelings of loneliness as well as feelings of social isolation	Baseline
University of California, Los Angeles Loneliness Scale	designed to measure one's subjective feelings of loneliness as well as feelings of social isolation	Post Intervention (Approximately 12 Weeks from Baseline)
University of California, Los Angeles Loneliness Scale	designed to measure one's subjective feelings of loneliness as well as feelings of social isolation	Follow Up (3 Months after Intervention)

Collaborators and Investigators

• Sponsor: University of Washington

Publications and helpful links

General Publications

• 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.
• 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.
• 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
• 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.
• 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

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2019
• Primary Completion (Anticipated): June 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: November 27, 2018
• First Submitted That Met QC Criteria: December 4, 2018
• First Posted (Actual): December 6, 2018

Study Record Updates

• Last Update Posted (Actual): December 6, 2018
• Last Update Submitted That Met QC Criteria: December 4, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: STUDY00005196

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No