Internet-based Cognitive Behavioral Psychotherapy for Children and Adolescents With Obsessive-compulsive Disorder II
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Child Obsessive Compulsive Disorder Impact Scale (COIS-RC)
研究概览
简要总结
Internet-based psychotherapy for children and adolescents with obsessive-compulsive symptoms and an age of 6 to 18 years. Sessions are verified with teleconferencing with an psychotherapist, children and their parents. The psychotherapy is supported by an App and a wristband to obtain psychophysiological data. The investigators have already successfully performed a feasibility study.The goal of the current proposal is to develop an internet and smart phone delivered CBT (iCBT) for the treatment of pediatric OCD on the bases of the feasibility study. Internal testing on iCBT therapy package and developmental workchanges has been done. The investigators are now evaluating effectiveness in an RCT.
详细描述
In this study the investigators test effectiveness of an internet-based therapy approach for children with obsessive-compulsive disorders in an RCT design with a waiting control group. The investigators are planninng the investigation of 20 patients in each group.Therapy is verified by experts via teleconferences and a therapy app. Outcomes for the treatment group are evaluated before randomization (baseline, t0), 16 weeks (end of treatment, t1), 32 weeks (follow-up 1, t2), and 48 weeks after randomization (follow-up 2, t3). For the waiting list-group, outcomes are measured before the first randomization (baseline), at 16 weeks (waiting list period), 32 weeks (end of treatment), 48 weeks after the first randomization (follow-up I) and 64 weeks after the first randomization (follow-up II).
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
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children and adolescents (ages 6-18) with a primary DSM-5 obsessive-compulsive disorder and at least 1 primary caretaker
- •German-speaking (child & caretakers)
- •Family home equipped with broadband connection and appropriate computer, monitor, HD webcam, and speaker and smart phone
- •written informed content of the child and his caretaker
- •OCD as highest treatment priority
排除标准
- •IQ below 70
- •not speaking and understanding German
- •A psychiatric comorbidity that makes participation clinically inappropriate (for example, primary anorexia nervosa), depression with suicidality, psychosis or any other psychiatric disorder that requires acute treatment
结局指标
主要结局
Change in Child Obsessive Compulsive Disorder Impact Scale (COIS-RC)
时间窗: baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
A 33-item self-report questionnaire to the impact of OCD symptoms on the psychosocial functioning of the children.
Change in Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)
时间窗: baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
Interview/questionnaire for obsessive-compusive disorders.
Change in Youth Self-Report (YSR/11-18R)
时间窗: baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
A 112 item 3-point scale completed by the children themselves and addresses a variety of behavioral and emotional problems.
Change in Screen for Child Anxiety Related Emotional Disorders (SCARED)
时间窗: baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
The SCARED assesses DSM-IV anxiety symptoms.
Change in Clinical Global Impressions-Severity (CGI-S)
时间窗: baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
A clinical 7-point rating scale of symptom severity.
Change in Depression Inventory for Children and Adolescents (DIKJ)
时间窗: baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
The questionnaire measures depressive symptoms in the children. It has 26 items and a 4 point scale.
Change in Children's Global Assessment Scale (CGAS)
时间窗: baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
The CGAS is a measure of level of functioning in children and adolescents.
Change in Questionnaire for Measuring Health-Related Quality of Life in Children and Adolescents (KINDL)
时间窗: baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
A 24 item 5 point scale self-report questionnaire for children and parents to quality of life.
Change in Daily mood
时间窗: Every day throughout the therapy process
Children indicate their mood via app.
Change in Schedule for Affective Disorders and Schizophrenia for School-Age Children Present and Lifetime Version (K-SADS-PL)
时间窗: baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
Clinical interview for psychiatric disorders for children and parents.
Change in Child Behavior Checklist (CBCL/6-18R)
时间窗: baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
A 113-item 3-point questionnaire for parents that assesses a wide range of child behavioral and emotional problems.
Change in Junior temperament and character inventory (JTCI)
时间窗: baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
The questionnaire assesses temperament characteristics with 103/86 items and a 5-point scale.
Change in Clinical Global Impressions-Improvement (CGI-I)
时间窗: baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
A clinical 7-point rating scale of symptom severity.
Change in How strong OCD is
时间窗: Every day throughout the therapy process
Children and parants indicate how strong OCD is via app.
Change in Heart rate variability
时间窗: Every day throughout the therapy process
Heart rate variability as an indicator of stress levels is assessed with wristbands.
Change in time the OCD takes
时间窗: Every day throughout the therapy process
Children and parants indicate how much time OCD takes via app.
Change in HEXACO- Personality Inventory-Revised (HEXACO-PI-R)
时间窗: baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
This questionnaire assesses the core personality traits of children.
Change in Impairment by OCD symptoms
时间窗: Every day throughout the therapy process
Children and parents indicate impairment by OCD via app.
Change in Extend of avoidance behavior
时间窗: Every day throughout the therapy process
Children and parents indicate extend of avoidance behavior via app.
Change in How the week has been
时间窗: weekly throughout the therapy process
Children and parants indicate how the week has been via app.
Change in Anxiety ratings during exposures
时间窗: Every exposure throughout the therapy process
Children indicate how high anxiety was during exposures via app.
Change in Engagement- Fragebogen
时间窗: baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
Questionnaire for emotional, cognitive and behavioral engagement at school with 5 items each.
Change in Ulmer Life Quality Inventory for parents of chronically ill children(ULQIE)
时间窗: baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
Questionnaire to life quality of parents related to the impairment through the illness of the child.
Change in How the day has been
时间窗: Every day throughout the therapy process
Children indicate how good the day has been via app.
Change in How convinced the patient of his/her OCD thoughts is
时间窗: every exposure
assessed by App
次要结局
未报告次要终点
研究者
PD Dr. Annette Conzelmann
PD Dr. Annette Conzelmann
University Hospital Tuebingen