SIBS: Bariatric Surgery Study
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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. |
Outcome Measures
Primary Outcome Measures
- Patient Health Questionnaire-9 (PHQ-9) [Baseline]
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) [Post Intervention (Approximately 12 Weeks from Baseline)]
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) [Follow Up (3 Months after Intervention)]
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 [Baseline]
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 [Post Intervention (Approximately 12 Weeks from Baseline)]
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 [Follow Up (3 Months after Intervention)]
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 [Baseline]
a sensitive screening instrument for the abuse of drugs other than alcohol
- Drug Abuse Screening Test [Post Intervention (Approximately 12 Weeks from Baseline)]
a sensitive screening instrument for the abuse of drugs other than alcohol
- Drug Abuse Screening Test [Follow Up (3 Months after Intervention)]
a sensitive screening instrument for the abuse of drugs other than alcohol
- Paffenbarger Physical Activity Questionnaire [Baseline]
asks participants about their current and previous exercise habits
- Paffenbarger Physical Activity Questionnaire [Post Intervention (Approximately 12 Weeks from Baseline)]
asks participants about their current and previous exercise habits
- Paffenbarger Physical Activity Questionnaire [Follow Up (3 Months after Intervention)]
asks participants about their current and previous exercise habits
- Proximal Change Variables [Baseline]
assesses participant's eating habits as well as tobacco and alcohol use
- Proximal Change Variables [Post Intervention (Approximately 12 Weeks from Baseline)]
assesses participant's eating habits as well as tobacco and alcohol use
- Proximal Change Variables [Follow Up (3 Months after Intervention)]
assesses participant's eating habits as well as tobacco and alcohol use
- Weight Control Questionnaire [Baseline]
asks participants to report if they have ever used any weight control practices
- Weight Control Questionnaire [Post Intervention (Approximately 12 Weeks from Baseline)]
asks participants to report if they have ever used any weight control practices
- Weight Control Questionnaire [Follow Up (3 Months after Intervention)]
asks participants to report if they have ever used any weight control practices
- Fear of Intimacy Scale (FIS) [Baseline]
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) [Post Intervention (Approximately 12 Weeks from Baseline)]
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) [Follow Up (3 Months after Intervention)]
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 [Baseline]
provides an assessment of several domains of social support including tangible support, emotional support, affective support, and positive support
- Social Support Survey [Post Intervention (Approximately 12 Weeks from Baseline)]
provides an assessment of several domains of social support including tangible support, emotional support, affective support, and positive support
- Social Support Survey [Follow Up (3 Months after Intervention)]
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 [Baseline]
designed to measure one's subjective feelings of loneliness as well as feelings of social isolation
- University of California, Los Angeles Loneliness Scale [Post Intervention (Approximately 12 Weeks from Baseline)]
designed to measure one's subjective feelings of loneliness as well as feelings of social isolation
- University of California, Los Angeles Loneliness Scale [Follow Up (3 Months after Intervention)]
designed to measure one's subjective feelings of loneliness as well as feelings of social isolation
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Older than 18
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Speak English as a primary language
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Had Bariatric Surgery in the past 6-24 months (bypasses (Roux-en-Y) or sleeves)
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Yes to one or both of the first two PHQ-9 Questions
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Not pregnant
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Not traveling anywhere in the next 6 months
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No surgeries scheduled in the next 12 months
Exclusion Criteria:
• No exclusion criteria are utilized in the present study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Weight Loss Management Center at UWMC-Roosevelt | Seattle | Washington | United States | 98105 |
Sponsors and Collaborators
- University of Washington
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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
- STUDY00005196