Bariatric Surgery Study (SIBS)
4 décembre 2018 mis à jour par: 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.
Aperçu de l'étude
Statut
Inconnue
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Anticipé)
20
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
Washington
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Seattle, Washington, États-Unis, 98105
- Weight Loss Management Center at UWMC-Roosevelt
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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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Aucune intervention: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Patient Health Questionnaire-9 (PHQ-9)
Délai: 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)
Délai: 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)
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
World Health Organization Quality of Life
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: Post Intervention (Approximately 12 Weeks from Baseline)
|
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
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Anticipé)
1 janvier 2019
Achèvement primaire (Anticipé)
1 juin 2019
Achèvement de l'étude (Anticipé)
1 décembre 2019
Dates d'inscription aux études
Première soumission
27 novembre 2018
Première soumission répondant aux critères de contrôle qualité
4 décembre 2018
Première publication (Réel)
6 décembre 2018
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
6 décembre 2018
Dernière mise à jour soumise répondant aux critères de contrôle qualité
4 décembre 2018
Dernière vérification
1 décembre 2018
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- STUDY00005196
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
INDÉCIS
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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