An Adaptive Treatment Strategy for Adolescent Depression
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- CDRS-R Score
研究概览
简要总结
The purpose of the study is:
- to find out how long teenagers getting talk therapy (interpersonal psychotherapy) for depression should get therapy before the therapist decides whether or not the teenager is improving enough, and
- to compare two ways of providing treatment to teenagers who have not improved enough.
详细描述
Study Procedures
This study has three phases:
- The screening and eligibility phase:
Parent and child will conduct an initial evaluation that will last about 4 hours. The evaluator will ask questions and the participant will complete forms about his/her mood and behavior. This intake appointment will determine eligibility for the study. 2. The treatment phase: The child would begin a kind of talk therapy called interpersonal psychotherapy. The goal of the therapy is to decrease teenagers' depression by helping them improve their relationships and communication skills. The child will attend 12 therapy appointments over the course of 16 weeks. Each appointment will be 50 minutes long.
If the child is doing well with standard interpersonal therapy, it will be continued without change. If the child has not improved enough, we will change the treatment plan in one of two ways. The choice will be based on chance (sort of like flipping a coin) and will be done by a computer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adolescent meets DSM-IV-TR criteria for a diagnosis of Major Depressive Disorder, Dysthymia, or Depressive Disorder NOS; demonstrate symptoms of depression (CDRS-R > 35); and demonstrate impairment in general functioning (CGAS < 65).
- •Adolescents and parents must be English-speaking
排除标准
- •Adolescent meets criteria for a diagnosis of Schizophrenia, Bipolar Disorder, Psychosis, Substance Abuse, OCD, Conduct Disorder, Eating Disorder, PDD, or intellectual disability disorder.
- •Depressed adolescents who are actively suicidal with a plan and/or intent
- •Adolescent that are already receiving treatment for depression or if they are taking medication for a psychiatric diagnosis other than ADHD. Depressed adolescents with a comorbid diagnosis of ADHD who are on a stable dose of stimulant medication (> 3 months) will be eligible to participate in the studies.
- •Adolescent that have already received an adequate trial of IPT-A or fluoxetine.
- •Female adolescents who are pregnant, breastfeeding, or having unprotected sexual intercourse.
研究组 & 干预措施
Talk Therapy 4-Week Decision Point
Interpersonal psychotherapy that focuses on an adolescents relationship and communication skills in the context of of their depression. After 4 weeks of therapy, participants with at less than a 20% reduction in Hamilton Rating Scale for Depression (HRSD) score will be further randomized into 2 groups, increased dose of interpersonal psychotherapy frequency or introduction of fluoxetine therapy starting with 10 mg per day for the first week and 20 mg per day in the following 5 weeks. If HRSD scores meet target, patients continue to receive initial dose of interpersonal psychotherapy
干预措施: Fluoxetine (Drug)
Talk Therapy 4-Week Decision Point
Interpersonal psychotherapy that focuses on an adolescents relationship and communication skills in the context of of their depression. After 4 weeks of therapy, participants with at less than a 20% reduction in Hamilton Rating Scale for Depression (HRSD) score will be further randomized into 2 groups, increased dose of interpersonal psychotherapy frequency or introduction of fluoxetine therapy starting with 10 mg per day for the first week and 20 mg per day in the following 5 weeks. If HRSD scores meet target, patients continue to receive initial dose of interpersonal psychotherapy
干预措施: Increased Dose of Interpersonal Psychotherapy (Behavioral)
Talk Therapy 4-Week Decision Point
Interpersonal psychotherapy that focuses on an adolescents relationship and communication skills in the context of of their depression. After 4 weeks of therapy, participants with at less than a 20% reduction in Hamilton Rating Scale for Depression (HRSD) score will be further randomized into 2 groups, increased dose of interpersonal psychotherapy frequency or introduction of fluoxetine therapy starting with 10 mg per day for the first week and 20 mg per day in the following 5 weeks. If HRSD scores meet target, patients continue to receive initial dose of interpersonal psychotherapy
干预措施: Continue to Receive Initial Dose of Interpersonal Psychotherapy (Behavioral)
Talk Therapy 8-Week Decision Point
Interpersonal psychotherapy that focuses on an adolescents relationship and communication skills in the context of of their depression. After 8 weeks of therapy, participants with at less than a 40% reduction in Hamilton Rating Scale for Depression (HRSD) score will be further randomized into 2 groups, increased dose of interpersonal psychotherapy or introduction of fluoxetine therapy starting with 10 mg per day for the first week and 20 mg per day in the following 5 weeks. If HRSD scores meet target, patients continue to receive initial dose of interpersonal psychotherapy.
干预措施: Fluoxetine (Drug)
Talk Therapy 8-Week Decision Point
Interpersonal psychotherapy that focuses on an adolescents relationship and communication skills in the context of of their depression. After 8 weeks of therapy, participants with at less than a 40% reduction in Hamilton Rating Scale for Depression (HRSD) score will be further randomized into 2 groups, increased dose of interpersonal psychotherapy or introduction of fluoxetine therapy starting with 10 mg per day for the first week and 20 mg per day in the following 5 weeks. If HRSD scores meet target, patients continue to receive initial dose of interpersonal psychotherapy.
干预措施: Increased Dose of Interpersonal Psychotherapy (Behavioral)
Talk Therapy 8-Week Decision Point
Interpersonal psychotherapy that focuses on an adolescents relationship and communication skills in the context of of their depression. After 8 weeks of therapy, participants with at less than a 40% reduction in Hamilton Rating Scale for Depression (HRSD) score will be further randomized into 2 groups, increased dose of interpersonal psychotherapy or introduction of fluoxetine therapy starting with 10 mg per day for the first week and 20 mg per day in the following 5 weeks. If HRSD scores meet target, patients continue to receive initial dose of interpersonal psychotherapy.
干预措施: Continue to Receive Initial Dose of Interpersonal Psychotherapy (Behavioral)
结局指标
主要结局
CDRS-R Score
时间窗: Baseline and 16-weeks
The CDRS-R is a clinician-administered semi-structured interview that assesses symptoms of depression experienced during the previous 2-weeks. The first 14 items are rated on the basis of an interview. The remaining 3 items are rated by a clinician on the basis of the child's nonverbal behavior. Items scales are 1 to 5 for sleep, appetite, and speech and 1 to 7 for the remaining 14 items. Total scores are summed and range from 17 to 113, with lower scores indicating normality while higher scores indicate psychopathology. Lower scores post-intervention indicate treatment efficacy.
CGAS Score
时间窗: Baseline and 16-weeks
The Children's Global Assessment Scale (CGAS) is a numeric scale used by mental health clinicians to rate the general functioning. Scores range from 1 to 100, with high scores indicating better functioning. A score of 1-10 indicates the need for constant supervision, while a score of 91-100 indicates superior functioning.
SAS-SR Score
时间窗: Baseline and 16-weeks
The SAS-SR provides an understanding of an individual's level of satisfaction with his or her social situation, measuring the level of both behavioral and emotional social adjustment across four major areas (school, friends, family, and dating). Participants answer each item on a scale of 1 to 5. The total score also ranges from 1 to 5 and is the average of all item scores. The total score provides an index of social impairment with higher mean score indicating more difficulties with social adjustment. Lower scores post treatment indicate efficacy of the intervention.
次要结局
未报告次要终点