- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02449499
Adjunct Interpersonally Focused Psychodynamic Group Psychotherapy for Residual Depression Symptoms
Interpersonally Focused Psychodynamic Group Psychotherapy as Adjunct Treatment for Residual Symptoms of Major Depressive Disorder
Visão geral do estudo
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
Inscrição (Real)
Contactos e Locais
Locais de estudo
-
-
California
-
Palo Alto, California, Estados Unidos, 94304
- Stanford Psychiatry and Behavioral Science
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
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
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
Patrocinador
Investigadores
- Investigador principal: Carrie Holmberg, MD, PhD, Stanford Psychiatry and Behavioral Science
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
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 .