Bariatric Surgery Study (SIBS)
2018년 12월 4일 업데이트: Jonathan Kanter, University of Washington
A Social Functioning Intervention to Target Depression Post Bariatric Surgery
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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (예상)
20
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Washington
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Seattle, Washington, 미국, 98105
- Weight Loss Management Center at UWMC-Roosevelt
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: FAP Intervention Group
All of the clients in the FAP intervention group will begin treatment at the same time and complete 3 assessments.
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The intervention itself is based on the procedures of Functional Analytic Psychotherapy, a behavioral intervention focusing on improving social functioning.
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간섭 없음: Control Group
The clients in the control group will take their assessments at the same time as those in the FAP intervention group.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Patient Health Questionnaire-9 (PHQ-9)
기간: Baseline
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based directly on the nine diagnostic criteria for major depressive disorder in the Diagnostic and Statistical Manual Diploma in Social Medicine-IV
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Baseline
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Patient Health Questionnaire-9 (PHQ-9)
기간: Post Intervention (Approximately 12 Weeks from Baseline)
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based directly on the nine diagnostic criteria for major depressive disorder in the Diagnostic and Statistical Manual Diploma in Social Medicine-IV
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Post Intervention (Approximately 12 Weeks from Baseline)
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Patient Health Questionnaire-9 (PHQ-9)
기간: Follow Up (3 Months after Intervention)
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based directly on the nine diagnostic criteria for major depressive disorder in the Diagnostic and Statistical Manual Diploma in Social Medicine-IV
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Follow Up (3 Months after Intervention)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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World Health Organization Quality of Life
기간: Baseline
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a measure of an individual's physical health, psychological state, personal beliefs, social relationships and their relationship to salient features of their environment.
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Baseline
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World Health Organization Quality of Life
기간: Post Intervention (Approximately 12 Weeks from Baseline)
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a measure of an individual's physical health, psychological state, personal beliefs, social relationships and their relationship to salient features of their environment.
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Post Intervention (Approximately 12 Weeks from Baseline)
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World Health Organization Quality of Life
기간: Follow Up (3 Months after Intervention)
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a measure of an individual's physical health, psychological state, personal beliefs, social relationships and their relationship to salient features of their environment.
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Follow Up (3 Months after Intervention)
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Drug Abuse Screening Test
기간: Baseline
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a sensitive screening instrument for the abuse of drugs other than alcohol
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Baseline
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Drug Abuse Screening Test
기간: Post Intervention (Approximately 12 Weeks from Baseline)
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a sensitive screening instrument for the abuse of drugs other than alcohol
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Post Intervention (Approximately 12 Weeks from Baseline)
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Drug Abuse Screening Test
기간: Follow Up (3 Months after Intervention)
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a sensitive screening instrument for the abuse of drugs other than alcohol
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Follow Up (3 Months after Intervention)
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Paffenbarger Physical Activity Questionnaire
기간: Baseline
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asks participants about their current and previous exercise habits
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Baseline
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Paffenbarger Physical Activity Questionnaire
기간: Post Intervention (Approximately 12 Weeks from Baseline)
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asks participants about their current and previous exercise habits
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Post Intervention (Approximately 12 Weeks from Baseline)
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Paffenbarger Physical Activity Questionnaire
기간: Follow Up (3 Months after Intervention)
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asks participants about their current and previous exercise habits
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Follow Up (3 Months after Intervention)
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Proximal Change Variables
기간: Baseline
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assesses participant's eating habits as well as tobacco and alcohol use
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Baseline
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Proximal Change Variables
기간: Post Intervention (Approximately 12 Weeks from Baseline)
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assesses participant's eating habits as well as tobacco and alcohol use
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Post Intervention (Approximately 12 Weeks from Baseline)
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Proximal Change Variables
기간: Follow Up (3 Months after Intervention)
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assesses participant's eating habits as well as tobacco and alcohol use
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Follow Up (3 Months after Intervention)
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Weight Control Questionnaire
기간: Baseline
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asks participants to report if they have ever used any weight control practices
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Baseline
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Weight Control Questionnaire
기간: Post Intervention (Approximately 12 Weeks from Baseline)
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asks participants to report if they have ever used any weight control practices
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Post Intervention (Approximately 12 Weeks from Baseline)
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Weight Control Questionnaire
기간: Follow Up (3 Months after Intervention)
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asks participants to report if they have ever used any weight control practices
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Follow Up (3 Months after Intervention)
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Fear of Intimacy Scale (FIS)
기간: Baseline
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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
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Baseline
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Fear of Intimacy Scale (FIS)
기간: Post Intervention (Approximately 12 Weeks from Baseline)
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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
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Post Intervention (Approximately 12 Weeks from Baseline)
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Fear of Intimacy Scale (FIS)
기간: Follow Up (3 Months after Intervention)
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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
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Follow Up (3 Months after Intervention)
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Social Support Survey
기간: Baseline
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provides an assessment of several domains of social support including tangible support, emotional support, affective support, and positive support
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Baseline
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Social Support Survey
기간: Post Intervention (Approximately 12 Weeks from Baseline)
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provides an assessment of several domains of social support including tangible support, emotional support, affective support, and positive support
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Post Intervention (Approximately 12 Weeks from Baseline)
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Social Support Survey
기간: Follow Up (3 Months after Intervention)
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provides an assessment of several domains of social support including tangible support, emotional support, affective support, and positive support
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Follow Up (3 Months after Intervention)
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University of California, Los Angeles Loneliness Scale
기간: Baseline
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designed to measure one's subjective feelings of loneliness as well as feelings of social isolation
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Baseline
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University of California, Los Angeles Loneliness Scale
기간: Post Intervention (Approximately 12 Weeks from Baseline)
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designed to measure one's subjective feelings of loneliness as well as feelings of social isolation
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Post Intervention (Approximately 12 Weeks from Baseline)
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University of California, Los Angeles Loneliness Scale
기간: Follow Up (3 Months after Intervention)
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designed to measure one's subjective feelings of loneliness as well as feelings of social isolation
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Follow Up (3 Months after Intervention)
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- Sarwer DB, Moore RH, Spitzer JC, Wadden TA, Raper SE, Williams NN. A pilot study investigating the efficacy of postoperative dietary counseling to improve outcomes after bariatric surgery. Surg Obes Relat Dis. 2012 Sep-Oct;8(5):561-8. doi: 10.1016/j.soard.2012.02.010. Epub 2012 Mar 21.
- Buchwald H, Estok R, Fahrbach K, Banel D, Jensen MD, Pories WJ, Bantle JP, Sledge I. Weight and type 2 diabetes after bariatric surgery: systematic review and meta-analysis. Am J Med. 2009 Mar;122(3):248-256.e5. doi: 10.1016/j.amjmed.2008.09.041.
- Switzer, N.J., Debru, E., Church, N. et al. Curr Cardiovasc Risk Rep (2016) 10: 12. https://doi.org/10.1007/s12170-016-0492-7
- Mitchell JE, Crosby R, de Zwaan M, Engel S, Roerig J, Steffen K, Gordon KH, Karr T, Lavender J, Wonderlich S. Possible risk factors for increased suicide following bariatric surgery. Obesity (Silver Spring). 2013 Apr;21(4):665-72. doi: 10.1002/oby.20066.
- Kohlenberg, R. J., & Tsai, M. (1991). Functional analytic psychotherapy: Creating intense and curative therapeutic relationships. New York, NY, US: Plenum Press. http://dx.doi.org/10.1007/978-0-387-70855-3
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (예상)
2019년 1월 1일
기본 완료 (예상)
2019년 6월 1일
연구 완료 (예상)
2019년 12월 1일
연구 등록 날짜
최초 제출
2018년 11월 27일
QC 기준을 충족하는 최초 제출
2018년 12월 4일
처음 게시됨 (실제)
2018년 12월 6일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2018년 12월 6일
QC 기준을 충족하는 마지막 업데이트 제출
2018년 12월 4일
마지막으로 확인됨
2018년 12월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .