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临床试验/NCT02449499
NCT02449499终止不适用

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

Stanford University1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2015年4月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
25
试验地点
1
主要终点
psychological and general well-being index

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

psychological and general well-being index

时间窗: 6 months

次要结局

  • ICI (interpersonal communication inventory)(6 months)
  • ASQ (adult attachment style questionnaire)(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Carrie Holmberg

protocol director

Stanford University

研究点 (1)

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