Bariatric Surgery Study (SIBS)
4 de diciembre de 2018 actualizado por: 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.
Descripción general del estudio
Estado
Desconocido
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
20
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Jonathan Kanter, PhD
- Número de teléfono: 206-685-7462
- Correo electrónico: jonkan@uw.edu
Copia de seguridad de contactos de estudio
- Nombre: Elliot Wallace
- Número de teléfono: 206-685-7462
- Correo electrónico: elliotcw@uw.edu
Ubicaciones de estudio
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Washington
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Seattle, Washington, Estados Unidos, 98105
- Weight Loss Management Center at UWMC-Roosevelt
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Contacto:
- Ruth Foster-Koth, MA
- Número de teléfono: 206-598-1752
- Correo electrónico: rfosterk@uw.edu
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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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Sin intervención: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Patient Health Questionnaire-9 (PHQ-9)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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World Health Organization Quality of Life
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Anticipado)
1 de enero de 2019
Finalización primaria (Anticipado)
1 de junio de 2019
Finalización del estudio (Anticipado)
1 de diciembre de 2019
Fechas de registro del estudio
Enviado por primera vez
27 de noviembre de 2018
Primero enviado que cumplió con los criterios de control de calidad
4 de diciembre de 2018
Publicado por primera vez (Actual)
6 de diciembre de 2018
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
6 de diciembre de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
4 de diciembre de 2018
Última verificación
1 de diciembre de 2018
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- STUDY00005196
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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