Cognitive Behavioral Group Treatment for Adolescents With Obsessive-compulsive Disorder: An Open Trial Benchmarking Against Individual Treatment Effectiveness and Quality of Life
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- The Health-Related Quality of Life in children and adolescents - revised
研究概览
简要总结
Obsessive-compulsive disorder (OCD) is a debilitating disorder characterized by unwanted intrusive thoughts and disrupting repetitive rituals. Epidemiological studies estimate the prevalence of impairing OCD to be between 0.5-3.0 % in pediatric populations. Although OCD in youth is associated with substantial distress and functional impairment, access to evidence-based psychosocial treatments is limited. This is largely due to the fact that few clinicians are trained in the delivery of evidence-based treatments, such as exposure-based cognitive-behavioral therapy (CBT). Therefore it is of great importance to develop treatment programs that utilize therapist resources in the most efficient way.
Exposure-based CBT delivered in the context of a group, rather than individually, is one such option. However, there are currently no evidence-based group OCD treatment manuals for youth available to clinicians in Denmark. Therefore this project addresses an important clinical need. We evaluate a group-based CBT protocol for the treatment of youth with OCD, benchmarking treatment outcomes against data from a previous trial evaluating individual-based CBT and by comparing outcomes against a short waiting list period. Further, we will explore the impact of group-based CBT over a 36-month open follow-up interval on general functioning, relapse, recurrence rates, and the need for other treatments. Finally, a brief youth questionnaire assessing overall symptom severity relevant for the evaluation of outcomes in pediatric OCD will be translated and validated for future clinical and research use in Denmark.
The project will include 72 adolescents with a primary diagnosis of OCD referred for assessment and treatment at the OCD Clinic at Department of Child and Adolescent Psychiatry, Aarhus University Hospital, Psychiatry, Denmark. For benchmarking of treatment outcomes, the project will compare the results from the group-based CBT with data from 45 Danish patients previously enrolled in the individual-based CBT of the Nordic Long Term OCD Treatment Study at the same clinic.
详细描述
Aims and hypotheses. The main objective of the present study is to develop a group delivered treatment manual for youth with OCD and evaluate its efficacy relative to (1) a waiting list control condition and (2) outcomes from existing data from a study of individually delivered CBT using a benchmarking strategy. The efficacy of the new treatment manual will be evaluated at the end of 13 weeks of acute treatment and at 3-, 6- , 12-, 24- and 36-month follow-up.
Based on the previous research we hypothesize that: (i) G-CBT will show superiority to the waiting period condition, and (ii) G-CBT will show similar effectiveness compared to I-CBT at the end of acute treatment as well as at longer-term follow-up assessment points.
Secondary aims are to evaluate predictors of treatment response to G-CBT and to identify specific response trajectories, i.e. patterns of symptom fluctuation during treatment.
Based on the previous literature we want to explore whether: (1) youth in families with higher levels of family conflict, parental blame and lower levels of cohesion will benefit less from treatment when compared to youth without these family characteristics, (2) lower levels of initial and intermediate treatment motivation will be associated with lower levels of treatment gains, and (3) specific patient response trajectories possibly associated with the onset of specific treatment ingredients (i.e., initial psychoeducation, in session exposure and response prevention, specific work on obsessions, work meetings with parents, etc.) and/or with patient characteristics, i.e. OCD subtypes, can be identified.
Further, the aim is to develop and/or evaluate relevant Danish versions of clinical instruments for the assessment of pediatric OCD (symptoms and severity). More specifically, one aim is to develop and evaluate a short self-rating of OCD severity for youth with OCD, which can be utilized by therapists during treatment and as a tool for youth's self-monitoring of symptoms.
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
- 13 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •13 to 17 years of age
- •A primary diagnosis of OCD according to Schedule for Affective Disorders and Schizophrenia for School-Age Children - Present and Lifetime version for DSM-IV (K-SADS-PL).
- •Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)24 total score ≥ 16.
排除标准
- •meet the criteria for an intellectual disability (IQ < 70),
- •meet the criteria for psychotic disorder according to DSM-5,
- •meet the criteria for Asperger's, or Autistic syndrome with a Clinical Global Impression Scale - Severity (CGI-S) rating ≥ 4 or same or higher rating than CGI-S for OCD
- •meet the criteria for PDD-NOS with a Clinical Global Impression Scale - Severity (CGI-S) rating ≥ 4 or same or higher rating than CGI-S for OCD
- •meet the criteria for any co-occurring mental disorder according to the Diagnostic and statistical manual of mental disorders (DSM-5) with a CGI-S rating higher than CGI-S for OCD, indicating that OCD is not the primary treatment priority
- •have been treated with CBT six months prior to inclusion,
- •have been treated with (S)SRIs six months prior to inclusion (dose ≥50 mg),
- •have inadequate Danish language proficiency or both parents have inadequate Danish language proficiency
结局指标
主要结局
The Health-Related Quality of Life in children and adolescents - revised
时间窗: 36 months follow-up
The Health-Related Quality of Life in children and adolescents - revised (KINDL-R) measure key aspects of health related quality of life in children and adolescents. Separate questionnaires for ages 7-13 and 14-17 exist. A translated Danish version of the KINDL is available. This scale provides a more general evaluation of the young patient's overall well-being and thriving in several life areas: physical, emotional, self-esteem, family, friends, and school, representing the child's experiences during the past week. Each item is rated on a five-point Likert scale and all scores are transformed to a scale ranging from 0 to 100. All subscale scores are added together to form a total score, with higher scores indicating better outcome. The questionnaire has a disorder-related subscale that reflects the child's experience of OCD-related burden and this is not part of the total score. The primary outcome used in the present study is the KINDL-R self-report total score.
The Children's Yale-Brown Obsessive Compulsive Scale
时间窗: 36 months follow-up
The Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) 24 is a clinician rated, semi structured interview assessing past and current OCD symptom presentation as well as present OCD severity in patients aged 6-17 years. The instrument has a 72-item symptom checklist followed by 10 severity items, five for obsessions and five for compulsions (i.e., time occupied by symptoms, interference, distress, resistance, and degree of control over symptoms), with a total severity score ranging from 0 to 40. Higher scores indicate worse outcome. The instrument is the most frequently used to assess OCD in children and adolescents.
次要结局
- The Child Obsessive Compulsive Impact Scale - Child and Parent Versions - Revised (COIS-R-C/P)(Pre-wait/pre-treatment; Post-wait/pre-treatment; Mid-intensive-treatment; Post-intensive-treatment; Post-booster-treatment; 6 months follow-up; 12 months follow-up; 24 months follow-up; 36 months follow-up)
- The Screen for Child Anxiety Related Emotional Disorders(Pre-wait/pre-treatment; Post-wait/pre-treatment; Mid-intensive-treatment; Post-intensive-treatment; Post-booster-treatment; 6 months follow-up; 12 months follow-up; 24 months follow-up; 36 months follow-up)
- The Family Accommodation Scale(Pre-wait/pre-treatment; Post-wait/pre-treatment; Mid-intensive-treatment; Post-intensive-treatment; Post-booster-treatment; 6 months follow-up; 12 months follow-up; 24 months follow-up; 36 months follow-up)
- The Clinical Global Impression Scale(Pre-wait/pre-treatment; Post-wait/pre-treatment; Mid-intensive-treatment; Post-intensive-treatment; Post-booster-treatment; 6 months follow-up; 12 months follow-up; 24 months follow-up; 36 months follow-up)
- The Children's Global Assessment Scale(Pre-wait/pre-treatment; Post-wait/pre-treatment; Mid-intensive-treatment; Post-intensive-treatment; Post-booster-treatment; 6 months follow-up; 12 months follow-up; 24 months follow-up; 36 months follow-up)
- The Mood and Feelings Questionnaire(Pre-wait/pre-treatment; Post-wait/pre-treatment; Mid-intensive-treatment; Post-intensive-treatment; Post-booster-treatment; 6 months follow-up; 12 months follow-up; 24 months follow-up; 36 months follow-up)
研究者
Katja Anna Hybel
Senior researcher, PhD
Aarhus University Hospital