跳至主要内容
临床试验/NCT06894368
NCT06894368已完成不适用

Development and Evaluation of a Group Version of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Adolescents (UP-A) in a Spanish Public Mental Health Setting.

Universidad Nacional de Educación a Distancia2 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2022年11月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
31
试验地点
2
主要终点
Changes in Anxiety and Depressive Symptoms as Assessed by RCADS-30

研究概览

简要总结

The study aims to adapt the Spanish version of the UP-A to a group format in a public mental health setting for adolescents with moderate emotional symptoms and evaluate its clinical utility and feasibility. This includes assessing anxiety, depression, transdiagnostic variables, engagement, and satisfaction from adolescents, parents, and clinicians, with follow-ups at 3, 6 and 12 months. The goal is to improve adolescent mental health and explore whether this approach could help alleviate the pressure on public healthcare services.

详细描述

Anxiety and depression are among the most prevalent mental health disorders in adolescents, with growing concerns about their increasing incidence. Studies indicate that emotional disorders often co-occur due to shared transdiagnostic factors, such as poor emotion regulation, high negative affect, and cognitive avoidance. Given these shared mechanisms, transdiagnostic treatments like the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Adolescents (UP-A) have been developed to improve adaptive emotion regulation and reduce avoidance behaviors. While the UP-A has been primarily evaluated as an individual therapy, its adaptation to a group format could enhance accessibility and efficiency, particularly in public mental health settings.

This study aims to adapt the Spanish version of the UP-A to a group format for adolescents with moderate emotional symptoms in a public mental health setting and assess its clinical utility and feasibility. The program is administered at a public mental health center in Madrid, with 31 adolescents (ages 11-17) diagnosed with emotional disorders. The intervention consists of 16 weekly sessions for adolescents, alongside three parental sessions. The program incorporates modifications such as individual sessions for defining personal treatment goals, structured peer support, and behavioral reinforcement strategies.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Presenting a primary diagnosis of an emotional disorder with mild or moderate severity, including the following disorders based on DSM-5 categories: Depressive Disorders (Major Depressive Disorder and Persistent Depressive Disorder), Anxiety Disorders (Specific Phobia, Panic Disorder, Agoraphobia, Social Anxiety Disorder, Generalized Anxiety Disorder), Obsessive-Compulsive and Related Disorders (including Body Dysmorphic Disorder, Hoarding Disorder, Trichotillomania and Excoriation (Skin-Picking) Disorder), Trauma and Stressor-Related Disorders (Reactive Attachment Disorder, Post-Traumatic Stress Disorder, Acute Stress Disorder and Adjustment Disorders), Dissociative Disorders (Dissociative Identity Disorder, Depersonalization/Derealization Disorder) and Somatic Symptom and Related Disorders (Somatic Symptom Disorder and Illness Anxiety Disorder). Specified and unspecified disorders from the above categories were also included.
  • Being 11-18 years of age
  • Being proficient in Spanish
  • The adolescent being able to attend the treatment sessions
  • At least one of the adolescent's parents or legal guardians being able to attend the parents' treatment sessions
  • If the participant was taking psychiatric medication, the dose was required to remain stable for at least 1 month before the start of treatment and throughout it

排除标准

  • Presenting self-harm or suicidal ideation in a moderate or severe degree
  • Presenting certain of the following clinical conditions (either as a main or comorbid diagnosis): Neurodevelopmental Disorders (Intellectual Disability or Autism Spectrum Disorder); Disruptive, Impulse-Control and Conduct Disorders; Eating Disorders; Psychotic Spectrum Disorders or psychotic-type symptoms,; Substance Abuse Disorders (excluding cannabis, coffee and/or nicotine); high severity Emotional Disorders; and Bipolar Disorders
  • The characteristics or severity of the symptoms presented by the adolescent requiring an individual intervention or one adapted to the specific clinical condition
  • Be receiving public or private psychological treatment during the UP-A program
  • Suffering from a serious medical illness that made the adolescent's participation in the treatment program unsustainable
  • The participant, or if under 16 years of age, his or her parents, having refused to sign the informed consent

结局指标

主要结局

Changes in Anxiety and Depressive Symptoms as Assessed by RCADS-30

时间窗: Up to 12 months

The Revised Child Anxiety and Depression Scale-30 (RCADS-30; Sandín et al., 2010) at pre, post-intervention and 3, 6 and 12 months follow-up. Range from 0 to 90. Symptoms of anxiety (panic disorder, social phobia, separation anxiety disorder, generalized anxiety disorder, and obsessive-compulsive disorder) and depressive disorders symptoms. Higher scores mean a worse outcome. Parents completed the "parent version" of the RCADS.

Changes in Anxiety and Depressive Symptoms's Interference as Assessed by EIDAN

时间窗: Up to 12 months

Depression and Anxiety Interference Scale for Children and Adolescents EIDAN (Espinosa et al., 2022) . It is a 10-item self-reported instrument that evaluates the interference of emotional symptoms in the adolescent's daily functioning in the previous weeks, in several contexts (school, family and with peers). The higher the score, the higher the level of interference. Assessed at pre, post-intervention and 3, 6 and 12 months follow-up. Range from 10 to 40. Parents completed the "parent version" of the EIDAN.

Top Problems Measure

时间窗: Up to 12 months

The adolescent version of the Top Problem Assessment (TPA) (Ehrenreich, 2018; adapted from Weisz et al., 2011) was used to enhance treatment outcomes and strengthen the therapeutic alliance. Adolescents were asked to write down the issues that concerned them the most and assess the severity of each problem by rating its impact on daily functioning on a scale from 0 ("not a problem at all") to 10 ("very, very much a problem"). Each adolescent selected between one and three problems and evaluated their severity at five time points: at the beginning of the program (session 3), mid-treatment (session 8), the final session (session 16), and during follow-ups at 3, 6 and 12 months.

Changes in Emotion Regulation Strategies as Assessed by CERE

时间窗: Up to 12 months

Emotion Regulation Strategies Questionnaire CERE-II (Sandín et al., 2008). Adapted to Spanish by Sandín et al. (2008). Evaluates 7 subscales of the "emotion regulation" construct at pre, post-intervention and 3, 6 and 12 months follow-up. Higher scores in maladaptive regulation strategies (supression; rumination; distraction) and lower scores in adaptive strategies (attention/awareness/understanding; acceptance/tolerance; cognitive reappraisal; self-instructions) mean a worst outcome

Changes in Anxiety and Depressive Symptoms as Assessed by RCADS-30

时间窗: Up to 12 months

The Revised Child Anxiety and Depression Scale-30 (RCADS-30; Sandín et al., 2010) at pre, post-intervention and 3, 6 and 12 months follow-up. Range from 0 to 90. Symptoms of anxiety (panic disorder, social phobia, separation anxiety disorder, generalized anxiety disorder, and obsessive-compulsive disorder) and depressive disorders symptoms. Higher scores mean a worse outcome. Parents completed the "parent version" of the RCADS.

Changes in Anxiety and Depressive Symptoms's Interference as Assessed by EIDAN

时间窗: Up to 12 months

Depression and Anxiety Interference Scale for Children and Adolescents EIDAN (Espinosa et al., 2022) . It is a 10-item self-reported instrument that evaluates the interference of emotional symptoms in the adolescent's daily functioning in the previous weeks, in several contexts (school, family and with peers). The higher the score, the higher the level of interference. Assessed at pre, post-intervention and 3, 6 and 12 months follow-up. Range from 10 to 40. Parents completed the "parent version" of the EIDAN.

Top Problems Measure

时间窗: Up to 12 months

The adolescent version of the Top Problem Assessment (TPA) (Ehrenreich, 2018; adapted from Weisz et al., 2011) was used to enhance treatment outcomes and strengthen the therapeutic alliance. Adolescents were asked to write down the issues that concerned them the most and assess the severity of each problem by rating its impact on daily functioning on a scale from 0 ("not a problem at all") to 10 ("very, very much a problem"). Each adolescent selected between one and three problems and evaluated their severity at five time points: at the beginning of the program (session 3), mid-treatment (session 8), the final session (session 16), and during follow-ups at 3, 6 and 12 months.

次要结局

  • Changes in Emotional Avoidance as Assessed by EASI(Up to 12 months)
  • Changes in Depressive Symptoms as Assessed by CDN(Up to 12 months)
  • Changes in Positive and Negative Affect as Assessed by PANASN(Up to 12 months)
  • Changes in Anxiety Sensitivity as Assessed by CASI(Up to 12 months)
  • Changes in Satisfaction with Life as Assessed by SWLS(Up to 12 months)
  • Changes in Attachment Styles as Assessed by ARSQ(Up to 12 months)
  • Changes in Somatic Symptoms as Assessed by PHQ-15(Up to 12 months)
  • Changes in Severity of Clinical Diagnosis as Assessed by CSR(16 weeks)
  • Changes in Level of Functioning as Assessed by CGAS(Up to 12 months)
  • Changes in Clinician Estimated Severity of Anxiety and Depressive Symptoms as Assessed by CGI-S(Up to 12 months)
  • Changes in Clinician Estimated Improvement of Anxiety and Depressive Symptoms as Assessed by CGI-I(Up to 12 months)
  • Satisfaction with the program and therapeutic alliance(16 weeks)
  • Changes in Positive and Negative Affect as Assessed by PANASN(Up to 12 months)
  • Changes in Anxiety Sensitivity as Assessed by CASI(Up to 12 months)
  • Changes in Emotional Avoidance as Assessed by EASI(Up to 12 months)
  • Changes in Satisfaction with Life as Assessed by SWLS(Up to 12 months)
  • Changes in Attachment Styles as Assessed by ARSQ(Up to 12 months)
  • Changes in Somatic Symptoms as Assessed by PHQ-15(Up to 12 months)
  • Changes in Severity of Clinical Diagnosis as Assessed by CSR(16 weeks)
  • Changes in Level of Functioning as Assessed by CGAS(Up to 12 months)
  • Changes in Clinician Estimated Severity of Anxiety and Depressive Symptoms as Assessed by CGI-S(Up to 12 months)
  • Changes in Clinician Estimated Improvement of Anxiety and Depressive Symptoms as Assessed by CGI-I(Up to 12 months)
  • Satisfaction with the program and therapeutic alliance(16 weeks)

研究者

发起方
Universidad Nacional de Educación a Distancia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Julia García Escalera

Professor

Universidad Nacional de Educación a Distancia

研究点 (2)

Loading locations...

相似试验