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Bariatric Surgery Study

A Social Functioning Intervention to Target Depression Post Bariatric Surgery

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03766360
Acronym
SIBS
Enrollment
20
Registered
2018-12-06
Start date
2019-01-31
Completion date
2019-12-31
Last updated
2018-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression, Interpersonal Relations, Quality of Life

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.

Interventions

BEHAVIORALFunctional Analytical Psychotherapy (FAP)

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

Sponsors

University of Washington
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Patient Health Questionnaire-9 (PHQ-9)Baselinebased directly on the nine diagnostic criteria for major depressive disorder in the Diagnostic and Statistical Manual Diploma in Social Medicine-IV

Secondary

MeasureTime frameDescription
World Health Organization Quality of LifeBaselinea 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 TestBaselinea sensitive screening instrument for the abuse of drugs other than alcohol
Paffenbarger Physical Activity QuestionnaireBaselineasks participants about their current and previous exercise habits
Weight Control QuestionnaireBaselineasks participants to report if they have ever used any weight control practices
Fear of Intimacy Scale (FIS)BaselineThe 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 SurveyBaselineprovides an assessment of several domains of social support including tangible support, emotional support, affective support, and positive support
University of California, Los Angeles Loneliness ScaleBaselinedesigned to measure one's subjective feelings of loneliness as well as feelings of social isolation
Proximal Change VariablesBaselineassesses participant's eating habits as well as tobacco and alcohol use

Countries

United States

Contacts

Primary ContactJonathan Kanter, PhD
jonkan@uw.edu206-685-7462
Backup ContactElliot Wallace
elliotcw@uw.edu206-685-7462

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026