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临床试验/NCT04034576
NCT04034576已完成不适用

The Impact of Session-introducing Mindfulness and Relaxation Interventions in Individual Training Psychotherapies for Children and Adolescents: a Randomized Controlled Trial.

Heidelberg University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2019年2月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
1
主要终点
Changes in Youth Self-Report 11-18 R (YSR 11-18 R)

研究概览

简要总结

The study 'Mindfulness and Relaxation interventions in Individual Training Psychotherapies for Children and Adolescents' (MARS-CA) aims to examine the effects of short session-introducing interventions with mindfulness elements (SIIME) on juvenile patients' psychopathological symptomatology and therapeutic alliance at the beginning of the first 24 therapy sessions.

详细描述

Short session-introducing interventions with mindfulness elements (SIIME) shall be compared with session-introducing relaxation interventions (SIRI) and no session-introducing interventions (treatment as usual, (TAU)). Patients between 11 and 19 years and a primary diagnosis of hyperkinetic disorder, depressive disorder or anxiety disorder are invited to participate. Psychotherapy will be conducted by trainee therapists at a trainee outpatient clinic for children and adolescents. It is hypothesized that psychopathological symptomatology and therapeutic alliance improve more in the mindfulness condition than in the relaxation condition and TAU, and that mindfulness moderates the relationship between therapeutic alliance and psychopathological symptomatology stronger than the relaxation condition and TAU.

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
11 Years 至 19 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •A primary hyperkinetic disorder, depressive disorder or anxiety disorder diagnosis
  • •treatment at the Center for Psychological Psychotherapy, University of Heidelberg

排除标准

  • •age below 11 or above 19
  • •insufficient German language skills
  • •psychotic disorder
  • •acute suicidality

研究组 & 干预措施

TAU + mindfulness intervention

Experimental

The mindfulness-based intervention consists of three five to ten minutes session-introducing interventions (mindful walking, body scan, breathing space). At the beginning of each of the 24 therapy sessions patients receive one of the three mindfulness interventions. Each intervention is instructed for four sessions consecutively and eight sessions in total. After completion of the mindfulness intervention, the regular therapy session begins.

干预措施: Cognitive behavior therapy of trainee therapists (Behavioral)

TAU + relaxation intervention

Active Comparator

The relaxation interventions (progressive muscle relaxation (PMR), imagery journey, walking relaxation) are parallelized to the three mindfulness-based interventions. At the beginning of each of the 24 therapy sessions, patients receive one of the three relaxation interventions. Each intervention is instructed for four sessions consecutively and eight sessions in total. After completion of the relaxation intervention, the regular therapy session begins.

干预措施: Cognitive behavior therapy of trainee therapists (Behavioral)

Treatment as usual

Other

Standard cognitive behavior therapy treatment, based on the individualized case conception of the trainee therapist, is conducted during the whole treatment sessions. No particular session-introductions are applied.

干预措施: Cognitive behavior therapy of trainee therapists (Behavioral)

结局指标

主要结局

Changes in Youth Self-Report 11-18 R (YSR 11-18 R)

时间窗: on first treatment day, after 3 weeks, 10 weeks, 17 weeks, 24 weeks (in each case after a 50 minutes therapy session) and at a 6-month follow-up

The YSR 11-18 R measures general symptom severity in patients. Eight different subscales are differentiated across 112 items: anxious/depressed, withdrawn/depressed, somatic complaints, social problems, thought problems, attention problems, delinquent behavior, and aggressive behaviors. The three subscales anxious/depressed, withdrawn/depressed and somatic complaints are regarded as internalizing problems while the two subscales delinquent behavior and aggressive behavior are regarded as externalizing behavior. To calculate subscales as well as the total score corresponding items are summed. Items are rated on a 3-point Likert-scale (0 = not true, 1 = somewhat or sometimes true, 2 = very true or often true). Higher scores reflect higher symptom severity. T-scores are used to interpret and compare the results to the corresponding age and gender group.

次要结局

  • Kentucky Inventory of Mindfulness Skills (KIMS-D)(on first treatment day, after 3 weeks, 10 weeks, 17 weeks, 24 weeks (in each case after a 50 minutes therapy session) and at a 6-month follow-up)
  • Therapeutic Alliance Scale for Children (FTB-KJ)(measured for 24 weeks on weekly basis at the end of each session (session duration is 50 minutes), starting on first treatment day)
  • Self-compassion scale (SCS-D)(on first treatment day, after 3 weeks, 10 weeks, 17 weeks, 24 weeks (in each case after a 50 minutes therapy session) and at a 6-month follow-up)
  • Diagnostic System for Mental Disorders in Childhood and Adolescence (DISYPS-III), problem scales of the depression self-rating scale (SBB-DES)(on first treatment day, after 3 weeks, 10 weeks, 17 weeks, 24 weeks (in each case after a 50 minutes therapy session) and at a 6-month follow-up)
  • Child and Adolescent Mindfulness Measure (CAMM)(on first treatment day, after 3 weeks, 10 weeks, 17 weeks, 24 weeks (in each case after a 50 minutes therapy session) and at a 6-month follow-up)
  • Diagnostic System for Mental Disorders in Childhood and Adolescence (DISYPS-III), problem scales of the ADHD self-rating scale (SBB-ADHS) Title: Patients' hyperkinetic disorder symptoms(on first treatment day, after 3 weeks, 10 weeks, 17 weeks, 24 weeks (in each case after a 50 minutes therapy session) and at a 6-month follow-up)
  • Diagnostic System for Mental Disorders in Childhood and Adolescence (DISYPS-III), problem scales of the anxiety self-rating scale (SBB-ANG)(on first treatment day, after 3 weeks, 10 weeks, 17 weeks, 24 weeks (in each case after a 50 minutes therapy session) and at a 6-month follow-up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Julia Kalmar

Dr. Julia Kalmar

Heidelberg University

研究点 (1)

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