Bariatric Surgery Study

NCT ID: NCT03766360

Last Updated: 2018-12-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-31
• Study Completion Date: 2019-12-31

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.

Conditions

Depression; Quality of Life; Interpersonal Relations

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

FAP Intervention Group

All of the clients in the FAP intervention group will begin treatment at the same time and complete 3 assessments.

Group Type: EXPERIMENTAL

Functional Analytical Psychotherapy (FAP)

Intervention Type: BEHAVIORAL

The intervention itself is based on the procedures of Functional Analytic Psychotherapy, a behavioral intervention focusing on improving social functioning.

Control Group

The clients in the control group will take their assessments at the same time as those in the FAP intervention group.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Functional Analytical Psychotherapy (FAP)

The intervention itself is based on the procedures of Functional Analytic Psychotherapy, a behavioral intervention focusing on improving social functioning.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Jonathan Kanter

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Weight Loss Management Center at UWMC-Roosevelt

Seattle, Washington, United States

Countries

United States

Central Contacts

Jonathan Kanter, PhD

Role: CONTACT

jonkan@uw.edu

206-685-7462

Elliot Wallace

Role: CONTACT

elliotcw@uw.edu

206-685-7462

Facility Contacts

Ruth Foster-Koth, MA

Role: primary

rfosterk@uw.edu

206-598-1752

References

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.

Reference Type: BACKGROUND

PMID: 19272486 (View on PubMed)

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

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 23404774 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22551576 (View on PubMed)

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

Reference Type: BACKGROUND

Other Identifiers

STUDY00005196

Identifier Type: -

Identifier Source: org_study_id