Bariatric Surgery Study
SIBS
A Social Functioning Intervention to Target Depression Post Bariatric Surgery
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable depression
Started Jan 2019
Shorter than P25 for not_applicable depression
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 27, 2018
CompletedFirst Posted
Study publicly available on registry
December 6, 2018
CompletedStudy Start
First participant enrolled
January 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedDecember 6, 2018
December 1, 2018
5 months
November 27, 2018
December 4, 2018
Conditions
Outcome Measures
Primary Outcomes (3)
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 Outcomes (24)
World Health Organization Quality of Life
Baseline
World Health Organization Quality of Life
Post Intervention (Approximately 12 Weeks from Baseline)
World Health Organization Quality of Life
Follow Up (3 Months after Intervention)
Drug Abuse Screening Test
Baseline
Drug Abuse Screening Test
Post Intervention (Approximately 12 Weeks from Baseline)
- +19 more secondary outcomes
Study Arms (2)
FAP Intervention Group
EXPERIMENTALAll of the clients in the FAP intervention group will begin treatment at the same time and complete 3 assessments.
Control Group
NO INTERVENTIONThe clients in the control group will take their assessments at the same time as those in the FAP intervention group.
Interventions
The intervention itself is based on the procedures of Functional Analytic Psychotherapy, a behavioral intervention focusing on improving social functioning.
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Weight Loss Management Center at UWMC-Roosevelt
Seattle, Washington, 98105, United States
Related Publications (5)
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.
PMID: 19272486BACKGROUNDSwitzer, N.J., Debru, E., Church, N. et al. Curr Cardiovasc Risk Rep (2016) 10: 12. https://doi.org/10.1007/s12170-016-0492-7
BACKGROUNDMitchell 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.
PMID: 23404774BACKGROUNDSarwer 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.
PMID: 22551576BACKGROUNDKohlenberg, 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
BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
November 27, 2018
First Posted
December 6, 2018
Study Start
January 1, 2019
Primary Completion
June 1, 2019
Study Completion
December 1, 2019
Last Updated
December 6, 2018
Record last verified: 2018-12