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临床试验/NCT07396363
NCT07396363已完成不适用

The Effect of Psychoeducational Psychotherapy on Neurocognitive Functions, Quality of Life, And Emotion Regulation in Adolescents Diagnosed With Bipolar Disorder: A Randomized Controlled Trial

Dokuz Eylul University1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2017年1月24日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
32
试验地点
1
主要终点
the Difficulties in Emotion Regulation Scale (DERS)

研究概览

简要总结

This study evaluated the effects of psychoeducational psychotherapy (PEP) on neurocognitive functions, symptomatology, quality of life, and emotion regulation in euthymic adolescents with bipolar disorder (BD). Thirty-two adolescents with BD were randomized, with 16 receiving PEP. Assessments included the Wisconsin Card Sorting Test, Stroop Test, Pediatric Quality-of-Life Inventory, Difficulties in Emotion Regulation Scale (DERS), Affective Reactivity Index, Young Mania Rating Scale, and Children's Depression Rating Scale.

详细描述

This study aimed to examine the impact of PEP on neurocognitive performance, symptom levels, quality of life, and emotion regulation among euthymic adolescents diagnosed with BD. A total of 32 adolescents meeting diagnostic criteria for BD were randomly assigned to either an intervention group (n = 16), which received PEP, or a control group receiving standard care. Participants were evaluated using a comprehensive assessment battery that included the Wisconsin Card Sorting Test and the Stroop Test to measure executive functioning; the Pediatric Quality-of-Life Inventory to assess well-being; the DERS and the Affective Reactivity Index for emotional functioning; and the Young Mania Rating Scale and Children's Depression Rating Scale to evaluate mood symptoms.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • Patients between the ages of 12 and 18 years who were diagnosed with BD (Bipolar Disorder)

排除标准

  • Presence of chronic medical disorders, a clinical diagnosis of autism spectrum disorder, mental retardation or intellectual disability (according to developmental/academic history and clinical examination), past or current epilepsy, brain injury, and cerebral palsy

研究组 & 干预措施

Psychoeducational psychotherapy (PEP)

Experimental

PEP is a structured, manualized, family-focused psychotherapy based on cognitive behavioral therapy (CBT). Participants were invited to participate in weekly parent and child sessions over a 12-week period. Each session lasted approximately 45-50 minutes, with a total of 24 sessions available throughout the trial. Parental involvement was incorporated into every PEP session, with parents joining for 5-10 minutes at the beginning of each child session to discuss the child's progress and for another 5-10 minutes at the end to review newly introduced material.

干预措施: Psychoeducational psychotherapy (PEP) (Behavioral)

Control

No Intervention

Control group who received routine treatment and care.

结局指标

主要结局

the Difficulties in Emotion Regulation Scale (DERS)

时间窗: 12 weeks

The Difficulties in Emotion Regulation Scale (DERS) assesses emotion regulation (ER) problems in adolescents across six domains: goals, strategies, impulsivity, awareness, clarity, and non-acceptance. Higher scores reflect greater ER difficulties. The Turkish version demonstrated good reliability and validity.

次要结局

  • Wisconsin Card Sorting Test(12 weeks)
  • The Pediatric Quality of life Inventory (PedsQL)(12 weeks)
  • Affective Reactivity Index-Child and Parent Forms(12 weeks)
  • Young Mania Rating Scale(12 weeks)

研究者

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

Ezgi Karagoz Tanigor M.D.

Doctor in Child and Adolescent Psychiatry department

Dokuz Eylul University

研究点 (1)

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