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Adjunct Interpersonally Focused Psychodynamic Group Psychotherapy for Residual Depression Symptoms

14 de outubro de 2016 atualizado por: Carrie Holmberg, Stanford University

Interpersonally Focused Psychodynamic Group Psychotherapy as Adjunct Treatment for Residual Symptoms of Major Depressive Disorder

Depression and anxiety disorders, even when treated according to standard of care consisting of individual treatment with medication and/or therapy, can be associated with significant residual impact on quality of life. The purpose of this research is carry out an observational study of an existing clinical treatment, adjunctive interpersonally focused psychodynamic group therapy, to determine if this can improve quality of life for patients who have residual symptoms of chronic depression and anxiety.

Visão geral do estudo

Status

Rescindido

Condições

Descrição detalhada

Patients will be referred from primary individual therapist at the Stanford psychiatry outpatient clinics or community. Patients meeting inclusion criteria will be contacted for consent to participate in intake process consisting of objective evaluation with Patient Health Questionnaire (PHQ9; assessment of mood), Generalized Anxiety Disorder Scale (GAD7; assessment of anxiety), Psychological General Well-Being Index (PGWBI), adult attachment style questionnaire (ASQ), and the interpersonal communication inventory (ICI), followed by standardized interpersonally oriented intake interview. Test and interview administration will be done by resident psychiatrists with training by supervising psychiatry faculty. A Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) diagnosis will be obtained using the Mini-International Neuropsychiatric Interview (MINI). Patients entered on antidepressants will be held at a stable dosage. Patients will be required to continue to see their individual therapist throughout the duration of their participation in the study, and will be asked for consent for group leaders to speak with individual therapist as clinically indicated.

A total of 25 patients are projected to be entered into the group. Rolling enrollment will proceed to maintain a minimum of 5 and maximum of 10 people in the group, as expected group therapy drop-out rates are on the order of 30%. This number of people is expected to provide sufficient group membership for effective interpersonal psychodynamic group therapy. The group will use psychodynamic principles tailored to the group setting, which focus on interpersonal dynamics happening within the group in real-time, as described in Dr. Irvin Yalom's Group Psychotherapy text. Sessions will be 75 minutes in length on a weekly basis. Sessions will be led by two senior (4th year) psychiatry residents and videotaped for supervision by two faculty psychiatrists. During the study, all group members will complete PHQ9, GAD7, and Sheehan disability scale prior to each group therapy session. The full battery of objective assessments delivered at the start of the study will be repeated every 6 months. Study will involve group participation for six months, with the option to continue in the group afterwards. Subjects who withdraw prior to 6 months will be asked to complete the full battery of objective assessments otherwise administered every 6 months and their data will be used as pilot data examining outcomes at intermediary time points.

Additionally, age and gender matched patients who meet inclusion criteria but are unable to attend group sessions due to scheduling conflict will be given objective scales described above at screening and at 6 months (or earlier if clinical or treatment status changes). This group will act as control. They will continue to engage in their typical individual psychiatric care, as the goal of this study is to examine additional benefit of adjunct group therapy above individual therapy alone.

Tipo de estudo

Observacional

Inscrição (Real)

25

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

    • California
      • Palo Alto, California, Estados Unidos, 94304
        • Stanford Psychiatry and Behavioral Science

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

Método de amostragem

Amostra Não Probabilística

População do estudo

Adult patients diagnosed with major depression, adjustment disorder, generalized anxiety disorder, panic disorder, social phobia, or other depression NOS diagnosis currently in treatment with individual psychotherapist, continuing to experience symptoms even after at least six months in standard individual treatment with a psychiatrist or psychologist.

Descrição

Inclusion Criteria:

  • MINI diagnosis of major depression, adjustment disorder, generalized anxiety disorder, panic disorder, social phobia, or depression not otherwise specified (NOS)
  • PHQ9 <20 and/or GAD7>5 despite minimum of 6 months of prior psychiatric treatment
  • Poor interpersonal, social, academic, work or home function based on clinical assessment and subjective self-report
  • Effective engagement with group therapy task as assessed during standardized initial screening which is to demonstrate a willingness and ability to engage in an effective therapeutic manner with others in the group
  • Ongoing treatment by primary individual psychotherapist
  • Insurance with behavioral health coverage accepted at Stanford clinics

Exclusion Criteria:

  • Active serious medical conditions
  • Traumatic Brain Injury (TBI), dementia, developmental delay or severe cognitive impairment
  • Psychotic or substance abuse issues
  • On newly prescribed psychiatric medication <30 days on stable target dose
  • Currently in acute depressive episode
  • Personality disorder
  • Suicidality
  • Inability to speak/understand English fluently

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

Coortes e Intervenções

Grupo / Coorte
therapy
patients who meet inclusion criteria, continue to work with individual therapist, and participate in adjunct weekly group therapy
control
patients who meet inclusion criteria, continue to work with individual therapist, and are eligible for group therapy participation but cannot participate in group due to schedule constraints

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Prazo
psychological and general well-being index
Prazo: 6 months
6 months

Medidas de resultados secundários

Medida de resultado
Prazo
ASQ (adult attachment style questionnaire)
Prazo: 6 months
6 months
ICI (interpersonal communication inventory)
Prazo: 6 months
6 months

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Investigadores

  • Investigador principal: Carrie Holmberg, MD, PhD, Stanford Psychiatry and Behavioral Science

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

1 de abril de 2015

Conclusão Primária (Real)

1 de outubro de 2015

Conclusão do estudo (Real)

1 de outubro de 2016

Datas de inscrição no estudo

Enviado pela primeira vez

7 de abril de 2015

Enviado pela primeira vez que atendeu aos critérios de CQ

15 de maio de 2015

Primeira postagem (Estimativa)

20 de maio de 2015

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

17 de outubro de 2016

Última atualização enviada que atendeu aos critérios de controle de qualidade

14 de outubro de 2016

Última verificação

1 de outubro de 2016

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • IRB-32272

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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