Bariatric Surgery Study

Depression Clinical Trial

— SIBS  

Official title:

A Social Functioning Intervention to Target Depression Post Bariatric Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03766360
• Other study ID #: STUDY00005196
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2019
• Est. completion date: December 2019

Study information

• Verified date: December 2018
• Source: University of Washington
• Contact: Jonathan Kanter, PhD
• Phone: 206-685-7462
• Email: jonkan[@]uw.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Interpersonal Relations
• Quality of Life

Intervention

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.

Locations

Country	Name	City	State
United States	Weight Loss Management Center at UWMC-Roosevelt	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
University of Washington

Country where clinical trial is conducted

United States, 

References & 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. Review. — View 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

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. Review. — View 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. — View 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

Outcome

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