Transdiagnostic Group Cognitive Behavioral Therapy Versus Group Relaxation Therapy for Adolescents With Emotional Disorders (PsicAP-A): Protocol
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 160
- 试验地点
- 4
- 主要终点
- Depressive symptoms
研究概览
简要总结
Emotional disorders such as anxiety and depression are highly prevalent during adolescence and associated with functional impairment that commonly extends into adulthood. In the primary care (PC) setting, these disorders are frequently underdiagnosed and undertreated. Objective: To carry out a prospective, randomized controlled trial (RCT) to test the efficacy of a new transdiagnostic cognitive behavioural group therapy (TD-CBT) protocol for adolescents (age 12 to 18 years) compared to group relaxation therapy (RT). Methods: Two-arm, single-blind, RCT (expected N=160) to compare group TD-CBT for emotional disorders to group RT. The group TD-CBT will be administered in seven sessions (90 min/session) over 12 weeks. Psychological assessments will be carried out at baseline, post-treatment, and at months 3, 6, and 12 after treatment. The assessments will include measures of depression, anxiety, somatization, quality of life, disability, and cognitive-emotional factors. The study will be conducted in two PC centres located in Cantabria, Spain. Discussion: This is the first RCT to evaluate the efficacy of group TD-CBT for emotional disorders in adolescents in the PC setting in Spain. If, as expected, the results confirm the superiority of TD-CBT to conventional RT, the widespread implementation of this new approach-based on scientific evidence obtained in a real-world, primary care setting-could improve treatment outcomes and quality of life in adolescents suffering from anxiety or depression.
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
- None
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
- 否
入选标准
- •Patients aged 12 to 17, inclusive, who present to the PC centre seeking treatment for symptoms of anxiety or depression.
- •Scores above the predetermined cut-off points on the GAD-7 (>= 5) and PHQ-9 (>= 5).
- •Agreement to participate in the study, with written informed consent provided by both patients and parents/guardians.
排除标准
- •Presence of any severe mental disorder, including autism spectrum disorders, bipolar disorder, schizophrenia, anorexia nervosa, substance dependence, personality disorder, and major depressive disorder (PHQ-9> 20).
- •Presence of severe or recent suicide attempts
- •Moderate or severe behaviour disorder that could interfere with the dynamics of the therapy groups.
- •Presence of a mental disability (IQ < 75).
- •Be receiving psychological treatment or any type of specialized care related to mental health.
- •Receiving any psychopharmacological treatment.
- •Parents involved in legal litigation due to separation or divorce.
结局指标
主要结局
Depressive symptoms
时间窗: 12 month follow-up period.
Patient Health Questionnaire - 9 item (PHQ-9), adolescent version. Nine items assessing depressive symptoms with Likert response with values ranging from 0 to 3 (Total score range: 0-27; higher scores means a worse outcome)
Anxiety symptoms
时间窗: 12 month follow-up period.
Generalized Anxiety Disorder - 7 item (GAD-7). It is composed of 7 Likert response items, ranging from 0 to 3 points (Total score range: 0-21). Higher scores means a worse outcome.
次要结局
- Rumination(12 month follow-up period.)
- the Quality of life(12 month follow-up period.)
- Attentional and interpretative biases(12 month follow-up period.)
- Somatizations(12 month follow-up period.)
- Pathological worry(12 month follow-up period.)
- Metacognitive beliefs(12 month follow-up period.)
- Emotional regulation(12 month follow-up period.)