Bariatric Surgery Study (SIBS)
4 december 2018 uppdaterad av: 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.
Studieöversikt
Status
Okänd
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Förväntat)
20
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Washington
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Seattle, Washington, Förenta staterna, 98105
- Weight Loss Management Center at UWMC-Roosevelt
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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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Inget ingripande: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Patient Health Questionnaire-9 (PHQ-9)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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World Health Organization Quality of Life
Tidsram: 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
Tidsram: 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)
|
|
World Health Organization Quality of Life
Tidsram: 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.
|
Follow Up (3 Months after Intervention)
|
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Drug Abuse Screening Test
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Post Intervention (Approximately 12 Weeks from Baseline)
|
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
Tidsram: 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
Tidsram: 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
Tidsram: Post Intervention (Approximately 12 Weeks from Baseline)
|
assesses participant's eating habits as well as tobacco and alcohol use
|
Post Intervention (Approximately 12 Weeks from Baseline)
|
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Proximal Change Variables
Tidsram: Follow Up (3 Months after Intervention)
|
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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Post Intervention (Approximately 12 Weeks from Baseline)
|
|
Social Support Survey
Tidsram: 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
|
Follow Up (3 Months after Intervention)
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University of California, Los Angeles Loneliness Scale
Tidsram: 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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Förväntat)
1 januari 2019
Primärt slutförande (Förväntat)
1 juni 2019
Avslutad studie (Förväntat)
1 december 2019
Studieregistreringsdatum
Först inskickad
27 november 2018
Först inskickad som uppfyllde QC-kriterierna
4 december 2018
Första postat (Faktisk)
6 december 2018
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
6 december 2018
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
4 december 2018
Senast verifierad
1 december 2018
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- STUDY00005196
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