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临床试验/NCT05575960
NCT05575960招募中不适用

Interpersonal Psychotherapy for Adolescents and Young Adults

Linnaeus University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年10月3日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
Patient Health Questionnaire - 9 for depression/Eating Disorder Inventory - Very Short for eating disorder patients

研究概览

简要总结

The purpose of the project is to study the effectiveness of Interpersonal Psychotherapy (IPT) for adolescents with depression. Specific aims are to analyze the effects, change mechanisms, predictors, and implementation of IPT for youth. In this four-year project we will include 60 patients with depression. Outcome will be studied using a quasi-experimental multiple-baseline design. Change mechanisms will be studied in the form of mentalizing, emotion regulation, social support, and working alliance session-by-session, and with post-treatment qualitative interviews about the participants' experiences of change. Predictors of effectiveness of IPT for adolescents will be explored by measuring severity of symptoms, anxiety symptoms, presence and severity of parent-child conflicts, quality of interpersonal relationships, experiences of bullying, and school functioning. The implementation process of IPT for youth will be studied through interviews with adolescents, parents, therapists, co-workers, and local managers.

The study is conducted within child and adolescent psychiatric services in Norrköping using a practice-oriented research strategy which emphasizes close collaboration with clinicians. The project is a collaboration between researchers at Linnaeus University and Linköping University, and clinicians at BUP Norrköping.

详细描述

Aim: To analyze the effects and the usefulness of IPT for adolescents with depression .

Site Norrköping Child and Adolescent Psychiatric Services BUP Norrköping receives approximately 820 new patient every year, and about 285 of these are diagnosed with depression. Seven therapists are working with IPT for adolescents. (Depression data)

Patients Inclusion and exclusion criteria will be evaluated using the Mini-International Neuropsychiatric Interview.

Therapists The requirement of therapists is to have IPT training of at least level B. All therapists will be employed within the Child and Adolescent Psychiatric Services, and work under the regulations of the Health Care Act.

Sample Size It is estimated that recruiting and treating 15-20 patients a year will be feasible. In four years, 60 adolescents with depression will be recruited.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Sequential
主要目的
Treatment
盲法
None

盲法说明

Not possible to mask psychotherapy for patient or therapist.

入排标准

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

入选标准

  • Major depressive disorder according to the DSM-V
  • Age 15 to 17,5 years.
  • Good-enough knowledge in Swedish to be able to read instructions in questionnaires and who do not require an interpreter.

排除标准

  • Ongoing psychosis
  • Drug or alcohol addiction
  • Bipolar disorder
  • Suspected mental retardation
  • Acute suicidality or severe depression requiring hospitalization
  • Patients who have started antidepressant medication within the last six weeks will need to wait until medication effects have stabilized.

结局指标

主要结局

Patient Health Questionnaire - 9 for depression/Eating Disorder Inventory - Very Short for eating disorder patients

时间窗: Change from treatment start to week 12 compared to change from before waiting-list to treatment start. In the multiple baseline design, the time for the waiting list varies, in this case about 4-25 weeks.

Patient-rated depression/eating disorder severity. Scale from 0-27 points, with higher scores indicating more severe symptoms.

Montgomery Åsberg Depression Rating Scale (observer version) for depression/Eating Disorder Inventory for eating disorders

时间窗: Change from treatment start to week 12 compared to change from before waiting-list to treatment start. In the multiple baseline design, the time for the waiting list varies, in this case about 4-25 weeks.

Depression/eating disorder severity measures. Scale from 0-60 points, with higher scores indicating more severe symptoms..

次要结局

未报告次要终点

研究者

发起方
Linnaeus University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Fredrik Falkenstrom

Professor of Clinical Psychology

Linnaeus University

研究点 (1)

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