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临床试验/NCT05468788
NCT05468788撤回不适用

Evaluating the Use of Theatre to Decrease Depression and Anxiety Among Adolescents With Chronic Medical Conditions (CMCs)

Geisinger Clinic2 个研究点 分布在 1 个国家开始时间: 2022年5月24日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Anxiety and Depression

研究概览

简要总结

Investigators are building a program that uses improvisation to teach kids and teens with medical issues healthy ways to cope. Medical issues have been linked to anxiety and depression. Doing theatre can prevent these complications. Participants will meet in groups of about ten for ten weeks to do improvisation that is fun and supportive. Participants will meet with a study team member before the program starts, after the program ends, six months after the program ends, and twelve months after the program ends. At these visits, participants will be screened for anxiety, depression, quality of life, and will be given a short interview.

详细描述

Adolescents with chronic medical conditions are at increased risk for anxiety and depression compared to other people their age. Therapies that use role-play prevent anxiety and depression. However, often these studies do not have an underlying psychological framework, or there is not enough information to replicate the program. Investigators designed an intervention using role-play based on Integrative Community Therapy, developed in the 1980s by Dr. Adalberto Barreto. This program will help adolescents with chronic medical conditions explore their feelings about issues related to having a chronic condition, learn new coping strategies, and help one another find support among peers.

This treatment will take place once a week for 10 weeks and investigators will compare the effects to those derived from improvisational theatre alone. To evaluate this new treatment, the study team will screen participants for anxiety, depression, quality of life, and will give a short qualitative interview. This will occur before and after the intervention, 6 months after the intervention, and 1 year after the intervention.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

盲法说明

The participants will not know which group they are in, as they will not be familiar with the particular procedure of the intervention being studied

入排标准

年龄范围
5 Years 至 19 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Identify as having a CMC
  • In grades kindergarten to 12th grade during the year recruited for the study
  • 5 years of age and ≤ 19 years of age at the start of the intervention
  • Able and willing to participate in improvisational theatre in spoken English
  • Able to understand and answer standard questionnaires used for evaluation in English (with or without accommodation)

排除标准

  • 未提供

结局指标

主要结局

Anxiety and Depression

时间窗: Baseline to 12 months

Anxiety and Depression as evaluated by the Revised Children's Anxiety and Depression Scale; Scored 0-30; higher score indicates worse outcome

Empathy

时间窗: Baseline to 12 months

Empathy as evaluated by Qualitative Interview

Knowledge and Utilization of Coping Strategies

时间窗: Baseline to 12 months

Knowledge and Utilization of Coping Strategies as evaluated by Qualitative Interview

Disease-Related Quality of Life

时间窗: Baseline to 12 months

Disease-Related Quality of Life as evaluated by Qualitative Interview

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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