Bariatric Surgery Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Social Functioning Intervention to Target Depression Post Bariatric Surgery

Conditions
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Depression, Quality of Life, Interpersonal Relations

Intervention / Treatment
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* Behavioral: Functional Analytical Psychotherapy (FAP)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FAP Intervention Group<br>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)<br>* The intervention itself is based on the procedures of Functional Analytic Psychotherapy, a behavioral intervention focusing on improving social functioning.<br>|
| No Intervention: Control Group<br>The clients in the control group will take their assessments at the same time as those in the FAP intervention group. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Health Questionnaire-9 (PHQ-9) | based directly on the nine diagnostic criteria for major depressive disorder in the Diagnostic and Statistical Manual Diploma in Social Medicine-IV | Baseline | 
| Patient Health Questionnaire-9 (PHQ-9) | based directly on the nine diagnostic criteria for major depressive disorder in the Diagnostic and Statistical Manual Diploma in Social Medicine-IV | Post Intervention (Approximately 12 Weeks from Baseline) | 
| Patient Health Questionnaire-9 (PHQ-9) | based directly on the nine diagnostic criteria for major depressive disorder in the Diagnostic and Statistical Manual Diploma in Social Medicine-IV | Follow Up (3 Months after Intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| World Health Organization Quality of Life | a measure of an individual's physical health, psychological state, personal beliefs, social relationships and their relationship to salient features of their environment. | Baseline | 
| World Health Organization Quality of Life | a measure of an individual's physical health, psychological state, personal beliefs, social relationships and their relationship to salient features of their environment. | Post Intervention (Approximately 12 Weeks from Baseline) | 
| World Health Organization Quality of Life | a measure of an individual's physical health, psychological state, personal beliefs, social relationships and their relationship to salient features of their environment. | Follow Up (3 Months after Intervention) | 
| Drug Abuse Screening Test | a sensitive screening instrument for the abuse of drugs other than alcohol | Baseline | 
| Drug Abuse Screening Test | a sensitive screening instrument for the abuse of drugs other than alcohol | Post Intervention (Approximately 12 Weeks from Baseline) | 
| Drug Abuse Screening Test | a sensitive screening instrument for the abuse of drugs other than alcohol | Follow Up (3 Months after Intervention) | 
| Paffenbarger Physical Activity Questionnaire | asks participants about their current and previous exercise habits | Baseline | 
| Paffenbarger Physical Activity Questionnaire | asks participants about their current and previous exercise habits | Post Intervention (Approximately 12 Weeks from Baseline) | 
| Paffenbarger Physical Activity Questionnaire | asks participants about their current and previous exercise habits | Follow Up (3 Months after Intervention) | 
| Proximal Change Variables | assesses participant's eating habits as well as tobacco and alcohol use | Baseline | 
| Proximal Change Variables | assesses participant's eating habits as well as tobacco and alcohol use | Post Intervention (Approximately 12 Weeks from Baseline) | 
| Proximal Change Variables | assesses participant's eating habits as well as tobacco and alcohol use | Follow Up (3 Months after Intervention) | 
| Weight Control Questionnaire | asks participants to report if they have ever used any weight control practices | Baseline | 
| Weight Control Questionnaire | asks participants to report if they have ever used any weight control practices | Post Intervention (Approximately 12 Weeks from Baseline) | 
| Weight Control Questionnaire | asks participants to report if they have ever used any weight control practices | Follow Up (3 Months after Intervention) | 
| Fear of Intimacy Scale (FIS) | 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 | Baseline | 
| Fear of Intimacy Scale (FIS) | 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 | Post Intervention (Approximately 12 Weeks from Baseline) | 
| Fear of Intimacy Scale (FIS) | 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 | Follow Up (3 Months after Intervention) | 
| Social Support Survey | provides an assessment of several domains of social support including tangible support, emotional support, affective support, and positive support | Baseline | 
| Social Support Survey | provides an assessment of several domains of social support including tangible support, emotional support, affective support, and positive support | Post Intervention (Approximately 12 Weeks from Baseline) | 
| Social Support Survey | provides an assessment of several domains of social support including tangible support, emotional support, affective support, and positive support | Follow Up (3 Months after Intervention) | 
| University of California, Los Angeles Loneliness Scale | designed to measure one's subjective feelings of loneliness as well as feelings of social isolation | Baseline | 
| University of California, Los Angeles Loneliness Scale | designed to measure one's subjective feelings of loneliness as well as feelings of social isolation | Post Intervention (Approximately 12 Weeks from Baseline) | 
| University of California, Los Angeles Loneliness Scale | designed to measure one's subjective feelings of loneliness as well as feelings of social isolation | Follow Up (3 Months after Intervention) |