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Bariatric Surgery Study

Not Applicable
Conditions
Depression
Quality of Life
Interpersonal Relations
Interventions
Behavioral: Functional Analytical Psychotherapy (FAP)
Registration Number
NCT03766360
Lead Sponsor
University of Washington
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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
20
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
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Exclusion Criteria

• No exclusion criteria are utilized in the present study.

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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
FAP Intervention GroupFunctional Analytical Psychotherapy (FAP)All of the clients in the FAP intervention group will begin treatment at the same time and complete 3 assessments.
Primary Outcome Measures
NameTimeMethod
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
NameTimeMethod
World Health Organization Quality of LifeFollow 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 TestFollow Up (3 Months after Intervention)

a sensitive screening instrument for the abuse of drugs other than alcohol

Paffenbarger Physical Activity QuestionnaireFollow Up (3 Months after Intervention)

asks participants about their current and previous exercise habits

Proximal Change VariablesFollow Up (3 Months after Intervention)

assesses participant's eating habits as well as tobacco and alcohol use

Weight Control QuestionnaireFollow Up (3 Months after Intervention)

asks participants to report if they have ever used any weight control practices

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 SurveyFollow 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 ScaleFollow Up (3 Months after Intervention)

designed to measure one's subjective feelings of loneliness as well as feelings of social isolation

Trial Locations

Locations (1)

Weight Loss Management Center at UWMC-Roosevelt

🇺🇸

Seattle, Washington, United States

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