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Bariatric Surgery Study (SIBS)

4. december 2018 opdateret af: 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.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

20

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Washington
      • Seattle, Washington, Forenede Stater, 98105
        • Weight Loss Management Center at UWMC-Roosevelt

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: FAP Intervention Group
All of the clients in the FAP intervention group will begin treatment at the same time and complete 3 assessments.
Adfærdsmæssigt: Functional Analytical Psychotherapy (FAP)
The intervention itself is based on the procedures of Functional Analytic Psychotherapy, a behavioral intervention focusing on improving social functioning.
Ingen indgriben: Control Group
The clients in the control group will take their assessments at the same time as those in the FAP intervention group.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Patient Health Questionnaire-9 (PHQ-9)
Tidsramme: Baseline
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)
Tidsramme: 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
Post Intervention (Approximately 12 Weeks from Baseline)
Patient Health Questionnaire-9 (PHQ-9)
Tidsramme: 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
Follow Up (3 Months after Intervention)

Sekundære resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Washington

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Forventet)

1. januar 2019

Primær færdiggørelse (Forventet)

1. juni 2019

Studieafslutning (Forventet)

1. december 2019

Datoer for studieregistrering

Først indsendt

27. november 2018

Først indsendt, der opfyldte QC-kriterier

4. december 2018

Først opslået (Faktiske)

6. december 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. december 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. december 2018

Sidst verificeret

1. december 2018

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • STUDY00005196

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

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