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Bariatric Surgery Study (SIBS)

4. Dezember 2018 aktualisiert von: 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.

Studienübersicht

Status

Unbekannt

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Voraussichtlich)

20

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • Washington
      • Seattle, Washington, Vereinigte Staaten, 98105
        • Weight Loss Management Center at UWMC-Roosevelt

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Unterstützende Pflege
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

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

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Patient Health Questionnaire-9 (PHQ-9)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
World Health Organization Quality of Life
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Baseline
a sensitive screening instrument for the abuse of drugs other than alcohol
Baseline
Drug Abuse Screening Test
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Baseline
asks participants about their current and previous exercise habits
Baseline
Paffenbarger Physical Activity Questionnaire
Zeitfenster: 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
Zeitfenster: Follow Up (3 Months after Intervention)
asks participants about their current and previous exercise habits
Follow Up (3 Months after Intervention)
Proximal Change Variables
Zeitfenster: Baseline
assesses participant's eating habits as well as tobacco and alcohol use
Baseline
Proximal Change Variables
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Baseline
asks participants to report if they have ever used any weight control practices
Baseline
Weight Control Questionnaire
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: Baseline
provides an assessment of several domains of social support including tangible support, emotional support, affective support, and positive support
Baseline
Social Support Survey
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of Washington

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Voraussichtlich)

1. Januar 2019

Primärer Abschluss (Voraussichtlich)

1. Juni 2019

Studienabschluss (Voraussichtlich)

1. Dezember 2019

Studienanmeldedaten

Zuerst eingereicht

27. November 2018

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

4. Dezember 2018

Zuerst gepostet (Tatsächlich)

6. Dezember 2018

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

6. Dezember 2018

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

4. Dezember 2018

Zuletzt verifiziert

1. Dezember 2018

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • STUDY00005196

Plan für individuelle Teilnehmerdaten (IPD)

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UNENTSCHIEDEN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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