Clinical trial NCT03766360: Bariatric Surgery Study
Official title: A Social Functioning Intervention to Target Depression Post Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
Quality of Life
Interpersonal Relations
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2018-12-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Exclusion Criteria:

• No exclusion criteria are utilized in the present study.

Primary outcomes:
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Baseline
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Post Intervention (Approximately 12 Weeks from Baseline)
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Follow Up (3 Months after Intervention)
Secondary outcomes:
measure: World Health Organization Quality of Life
timeFrame: Baseline
measure: World Health Organization Quality of Life
timeFrame: Post Intervention (Approximately 12 Weeks from Baseline)
measure: World Health Organization Quality of Life
timeFrame: Follow Up (3 Months after Intervention)
measure: Drug Abuse Screening Test
timeFrame: Baseline
measure: Drug Abuse Screening Test
timeFrame: Post Intervention (Approximately 12 Weeks from Baseline)
measure: Drug Abuse Screening Test
timeFrame: Follow Up (3 Months after Intervention)
measure: Paffenbarger Physical Activity Questionnaire
timeFrame: Baseline
measure: Paffenbarger Physical Activity Questionnaire
timeFrame: Post Intervention (Approximately 12 Weeks from Baseline)
measure: Paffenbarger Physical Activity Questionnaire
timeFrame: Follow Up (3 Months after Intervention)
measure: Proximal Change Variables
timeFrame: Baseline
measure: Proximal Change Variables
timeFrame: Post Intervention (Approximately 12 Weeks from Baseline)
measure: Proximal Change Variables
timeFrame: Follow Up (3 Months after Intervention)
measure: Weight Control Questionnaire
timeFrame: Baseline
measure: Weight Control Questionnaire
timeFrame: Post Intervention (Approximately 12 Weeks from Baseline)
measure: Weight Control Questionnaire
timeFrame: Follow Up (3 Months after Intervention)
measure: Fear of Intimacy Scale (FIS)
timeFrame: Baseline
measure: Fear of Intimacy Scale (FIS)
timeFrame: Post Intervention (Approximately 12 Weeks from Baseline)
measure: Fear of Intimacy Scale (FIS)
timeFrame: Follow Up (3 Months after Intervention)
measure: Social Support Survey
timeFrame: Baseline
measure: Social Support Survey
timeFrame: Post Intervention (Approximately 12 Weeks from Baseline)
measure: Social Support Survey
timeFrame: Follow Up (3 Months after Intervention)
measure: University of California, Los Angeles Loneliness Scale
timeFrame: Baseline
measure: University of California, Los Angeles Loneliness Scale
timeFrame: Post Intervention (Approximately 12 Weeks from Baseline)
measure: University of California, Los Angeles Loneliness Scale
timeFrame: Follow Up (3 Months after Intervention)
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Weight Loss Management Center at UWMC-Roosevelt
state: Washington
Study officials:
References:
citation: 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.
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
citation: 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.
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.
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