Bariatric Surgery Study (SIBS)

University of Washington

Status: Unknown

Conditions: Quality of Life; Depression; Interpersonal Relations

Treatments: Behavioral: Functional Analytical Psychotherapy (FAP)

Study type: Interventional

Funder types: Other

Identifiers

NCT03766360

STUDY00005196

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

FAP Intervention Group

Experimental group

Description:

All of the clients in the FAP intervention group will begin treatment at the same time and complete 3 assessments.

Treatment:

Behavioral: Functional Analytical Psychotherapy (FAP)

Control Group

No Intervention group

Description:

The clients in the control group will take their assessments at the same time as those in the FAP intervention group.