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Bariatric Surgery Study (SIBS)

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ClinicalTrials.gov Identifier: NCT03766360
Recruitment Status : Not yet recruiting
First Posted : December 6, 2018
Last Update Posted : December 6, 2018
Sponsor:
Information provided by (Responsible Party):
Jonathan Kanter, 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.

Condition or disease Intervention/treatment Phase
Depression Quality of Life Interpersonal Relations Behavioral: Functional Analytical Psychotherapy (FAP) Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Social Functioning Intervention to Target Depression Post Bariatric Surgery
Estimated Study Start Date : January 2019
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: FAP Intervention Group
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)
The intervention itself is based on the procedures of Functional Analytic Psychotherapy, a behavioral intervention focusing on improving social functioning.

No Intervention: Control Group
The clients in the control group will take their assessments at the same time as those in the FAP intervention group.



Primary Outcome Measures :
  1. Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: Baseline ]
    based directly on the nine diagnostic criteria for major depressive disorder in the Diagnostic and Statistical Manual Diploma in Social Medicine-IV

  2. Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: Post Intervention (Approximately 12 Weeks from Baseline) ]
    based directly on the nine diagnostic criteria for major depressive disorder in the Diagnostic and Statistical Manual Diploma in Social Medicine-IV

  3. Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: 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 :
  1. World Health Organization Quality of Life [ Time Frame: Baseline ]
    a measure of an individual's physical health, psychological state, personal beliefs, social relationships and their relationship to salient features of their environment.

  2. World Health Organization Quality of Life [ Time Frame: Post Intervention (Approximately 12 Weeks from Baseline) ]
    a measure of an individual's physical health, psychological state, personal beliefs, social relationships and their relationship to salient features of their environment.

  3. World Health Organization Quality of Life [ Time Frame: Follow 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.

  4. Drug Abuse Screening Test [ Time Frame: Baseline ]
    a sensitive screening instrument for the abuse of drugs other than alcohol

  5. Drug Abuse Screening Test [ Time Frame: Post Intervention (Approximately 12 Weeks from Baseline) ]
    a sensitive screening instrument for the abuse of drugs other than alcohol

  6. Drug Abuse Screening Test [ Time Frame: Follow Up (3 Months after Intervention) ]
    a sensitive screening instrument for the abuse of drugs other than alcohol

  7. Paffenbarger Physical Activity Questionnaire [ Time Frame: Baseline ]
    asks participants about their current and previous exercise habits

  8. Paffenbarger Physical Activity Questionnaire [ Time Frame: Post Intervention (Approximately 12 Weeks from Baseline) ]
    asks participants about their current and previous exercise habits

  9. Paffenbarger Physical Activity Questionnaire [ Time Frame: Follow Up (3 Months after Intervention) ]
    asks participants about their current and previous exercise habits

  10. Proximal Change Variables [ Time Frame: Baseline ]
    assesses participant's eating habits as well as tobacco and alcohol use

  11. Proximal Change Variables [ Time Frame: Post Intervention (Approximately 12 Weeks from Baseline) ]
    assesses participant's eating habits as well as tobacco and alcohol use

  12. Proximal Change Variables [ Time Frame: Follow Up (3 Months after Intervention) ]
    assesses participant's eating habits as well as tobacco and alcohol use

  13. Weight Control Questionnaire [ Time Frame: Baseline ]
    asks participants to report if they have ever used any weight control practices

  14. Weight Control Questionnaire [ Time Frame: Post Intervention (Approximately 12 Weeks from Baseline) ]
    asks participants to report if they have ever used any weight control practices

  15. Weight Control Questionnaire [ Time Frame: Follow Up (3 Months after Intervention) ]
    asks participants to report if they have ever used any weight control practices

  16. Fear of Intimacy Scale (FIS) [ Time Frame: Baseline ]
    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

  17. Fear of Intimacy Scale (FIS) [ Time Frame: Post Intervention (Approximately 12 Weeks from Baseline) ]
    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

  18. Fear of Intimacy Scale (FIS) [ Time Frame: 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

  19. Social Support Survey [ Time Frame: Baseline ]
    provides an assessment of several domains of social support including tangible support, emotional support, affective support, and positive support

  20. Social Support Survey [ Time Frame: Post Intervention (Approximately 12 Weeks from Baseline) ]
    provides an assessment of several domains of social support including tangible support, emotional support, affective support, and positive support

  21. Social Support Survey [ Time Frame: Follow Up (3 Months after Intervention) ]
    provides an assessment of several domains of social support including tangible support, emotional support, affective support, and positive support

  22. University of California, Los Angeles Loneliness Scale [ Time Frame: Baseline ]
    designed to measure one's subjective feelings of loneliness as well as feelings of social isolation

  23. University of California, Los Angeles Loneliness Scale [ Time Frame: Post Intervention (Approximately 12 Weeks from Baseline) ]
    designed to measure one's subjective feelings of loneliness as well as feelings of social isolation

  24. University of California, Los Angeles Loneliness Scale [ Time Frame: Follow Up (3 Months after Intervention) ]
    designed to measure one's subjective feelings of loneliness as well as feelings of social isolation



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03766360


Contacts
Contact: Jonathan Kanter, PhD 206-685-7462 jonkan@uw.edu
Contact: Elliot Wallace 206-685-7462 elliotcw@uw.edu

Locations
United States, Washington
Weight Loss Management Center at UWMC-Roosevelt Not yet recruiting
Seattle, Washington, United States, 98105
Contact: Ruth Foster-Koth, MA    206-598-1752    rfosterk@uw.edu   
Sponsors and Collaborators
University of Washington

Publications:
Responsible Party: Jonathan Kanter, Associate Professor, University of Washington
ClinicalTrials.gov Identifier: NCT03766360     History of Changes
Other Study ID Numbers: STUDY00005196
First Posted: December 6, 2018    Key Record Dates
Last Update Posted: December 6, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders