Computer-Assisted Cognitive-Behavioral Therapy for Adolescent Depression in Primary Care Clinics in Santiago, Chile (YPSA-M): A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 216
- 试验地点
- 1
- 主要终点
- Change from baseline in Beck Depression Inventory (BDI) at 4 months
研究概览
简要总结
Background: Most adolescents suffering depression are treated in primary care clinics. Cognitive-behavior therapy (CBT) is effective in the treatment of adolescent depression. The availability of appropriately trained CBT therapist may be limited, especially in primary care clinics. One way to increase the availability of CBT is to use computer-assisted CBT (c-CBT). It can be effective in the treatment of adults, although the outcomes in adolescents remain unclear.
Purpose: The purpose of this study is to determine whether a computer-assisted cognitive-behavioral therapy is effective for the treatment of depression in adolescents between 15 and 19 years of age in 4 primary care clinics in Santiago, Chile.
Study design: A two-arm single-blind (outcomes assessor) randomized controlled trial will be carried out with 216 adolescents. The efficacy, the adherence, and acceptability of the computerized-assisted cognitive behavioral therapy will be evaluated.
详细描述
This is a two-arm, single-blind (blinded only to outcome assessor), individually randomized controlled trial, which will compare the efficacy of computer-assisted CBT versus usual treatment for depression in adolescents in primary care clinics in Santiago, Chile.
General aim To carry out a randomized controlled trial to compare the efficacy of a computer-assisted CBT intervention versus usual care to treat depression in adolescents in primary care clinics in Santiago, Chile.
Specific aims
- To compare the level of depressive symptoms of adolescents suffering depression treated with computer-assisted CBT versus usual care in primary care clinics.
- To compare the level of dysfunctional thoughts, strategies for solving problems, and health-related quality of life (HRQoL) of adolescents suffering depression treated with computer-assisted CBT versus usual care in primary care clinics.
- To compare adolescents' adherence to computer-assisted CBT versus usual care in primary care clinics.
- To compare adolescents' satisfaction with computer-assisted CBT versus usual care in primary care clinics.
Hypotheses
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
- 15 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Beck Depression Inventory > o = 10
- •Meets diagnostic criteria of a depressive disorder according Kiddie Sads Present and Lifetime Version interview (K-SADS-PL)
- •Parent or caregiver giving informed consent and adolescent giving informed assent
排除标准
- •Suicidal risk requiring in-patient care
- •Bipolar Disorder
- •Current substance dependence
- •Current alcohol dependence
- •Current psychosis
- •Low intellectual abilities
- •Current treatment with antidepressant and/or psychotherapy
结局指标
主要结局
Change from baseline in Beck Depression Inventory (BDI) at 4 months
时间窗: Baseline and 4 months
次要结局
- Change from baseline in Social Problem Solving Inventory-Revised Short Form (SPSI-RS)(Baseline, 4 months, and 6 months)
- Change from baseline in KIDSCREEN-27(Baseline, 4 months, and 6 months)
- Change from baseline in Children's Automatic Thought Questionnaire (CATS)(Baseline, 4 months, and 6 months)
- Change from baseline in Beck Depression Inventory (BDI) at 6 months(Baseline and 6 months)
研究者
Vania Martínez-Nahuel
Dr.med.
University of Chile