Bariatric Surgery Study (SIBS)
4 de dezembro de 2018 atualizado 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.
Visão geral do estudo
Status
Desconhecido
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Intervencional
Inscrição (Antecipado)
20
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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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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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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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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Sem intervenção: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Patient Health Questionnaire-9 (PHQ-9)
Prazo: 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)
Prazo: 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)
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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World Health Organization Quality of Life
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- 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
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Antecipado)
1 de janeiro de 2019
Conclusão Primária (Antecipado)
1 de junho de 2019
Conclusão do estudo (Antecipado)
1 de dezembro de 2019
Datas de inscrição no estudo
Enviado pela primeira vez
27 de novembro de 2018
Enviado pela primeira vez que atendeu aos critérios de CQ
4 de dezembro de 2018
Primeira postagem (Real)
6 de dezembro de 2018
Atualizações de registro de estudo
Última Atualização Postada (Real)
6 de dezembro de 2018
Última atualização enviada que atendeu aos critérios de controle de qualidade
4 de dezembro de 2018
Última verificação
1 de dezembro de 2018
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- STUDY00005196
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
INDECISO
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Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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