跳至主要内容
临床试验/NCT06273137
NCT06273137招募中不适用

Mitigating Depression Among Adversity Exposed Adolescents Using Positive Affect Therapy

University of California, Irvine2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2024年2月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
300
试验地点
2
主要终点
depressive symptoms - anhedonia subscale

研究概览

简要总结

Youth exposed to early life adversity (ELA) are known to be at greater risk for depression and suicidality and account for almost half of the youth suffering from psychiatric diseases today. Youth exposed to ELA consistently report symptoms of anhedonia as well as dysregulated positive affect. The present project will test the efficacy of PAT in a sample of ELA-exposed adolescents in order to determine whether PAT increases positive affect, and subsequently symptoms of depression. For the initial pilot phase of the investigation, the investigators will recruit up to 30 adolescents exposed to two or more childhood adversities (ACEs) who do not currently have major depressive disorder, and randomize them (1:1) to either participate in PAT or a waitlist control condition. For the second phase of the investigation, the investigators will recruit up to 300 adolescents exposed to two or more childhood adversities (ACEs) who do not currently have major depressive disorder, and randomize them (1:1) to either participate in PAT or supportive psychotherapy. For both phases, at study enrollment, then 4-, 8, and 12-months thereafter the investigators will measure positive affect and depressive symptoms (including anhedonia and reward sensitivity). The results of this study will be used to inform whether PAT has the potential to prevent major depressive episodes among adversity-exposed youth.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
None

入排标准

年龄范围
12 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • aged 12-16
  • exposed to 2 or more adverse childhood experiences (ACEs)

排除标准

  • currently taking an antidepressant or any medications known to influence immune functioning on a daily basis (e.g., steroidal medications to treat asthma or allergies)
  • current or past history of manic or psychotic symptoms
  • parent-reported diagnosis of intellectual disability or autism spectrum disorder
  • chronic medical conditions (e.g., cancer, rheumatoid arthritis, diabetes, multiple sclerosis),
  • bleeding disorders such as hemophilia

研究组 & 干预措施

Waitlist

No Intervention

Positive affect treatment

Experimental

PAT is a 15-week cognitive-behavioral therapy that focuses on increasing reward motivation and sensitivity at the neural, behavioral, and affective levels of analysis. These observed effects occur through PAT's effects on reward sensitivity and positive affect. Participants will be assigned to a therapist with training in cognitive-behavioral therapy who will meet with them weekly via telehealth.

干预措施: Positive affect treatment (Behavioral)

Supportive Psychotherapy (SUP)

Active Comparator

Participants randomized to SUP will receive 15 weeks of SUP from a doctoral student in clinical psychology. SUP is a flexibly-delivered, manualized evidence-based treatment that focuses on reinforcing a patient's existing coping strategies while fostering a positive therapeutic relationship. Supportive psychotherapy provides a time, attention, and social support control that is similar to a placebo but likely to be perceived as relevant to this population.

干预措施: Supportive psychotherapy (SUP) (Behavioral)

结局指标

主要结局

depressive symptoms - anhedonia subscale

时间窗: 4 months / end of treatment

Reynolds Adolescent Depression Scale 2nd Edition - anhedonia subscale score; Scores can range from 7-28 with higher values indicating more severe anhedonia.

reward sensitivity

时间窗: 4 months / end of treatment

Reward motivation will be assessed behaviorally with the Effort Expenditures for Reward Task (EEfRT). The EEfRT assesses reward sensitivity by compelling participants to choose to engage in high and low effort motor tasks for varying potential monetary gains and computes reward sensitivity as the difference in propensity to choose hard choice trials at increasing trial values.

Systemic inflammation - C-reactive protein (CRP)

时间窗: 4 months / end of treatment

C-reactive protein concentrations measured in saliva; assay detection range is approximately 25 pg/mL - 1600 pg/mL with higher values indicating the presence of more systemic inflammation.

次要结局

  • Inflammatory gene expression(4 months / end of treatment)

研究者

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

Kate Kuhlman

Associate Professor

University of California, Irvine

研究点 (2)

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