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临床试验/CTRI/2024/11/076739
CTRI/2024/11/076739尚未招募3 期

Comparative study on impact of Cognitive Behavioural Therapy with Integrated Cognitive Behavioural and Art Based Therapy on Distress Cognitive distortions, Depression, Anxiety, Hope and Quality of Life among Children with cancer

Cancer Institute WIA1 个研究点 分布在 1 个国家目标入组 186 人开始时间: 2025年10月10日最近更新:

试验速览

阶段
3 期
状态
尚未招募
入组人数
186
试验地点
1
主要终点
To assess the level of Distress, Anxiety, Depression, Automatic thoughts and Quality of life among children with cancer

研究概览

简要总结

A trained psycho oncologist after obtaining consent, will conduct the first baseline assessment - the level of Distress(using the Paediatric Distress thermometer) experienced by the child (ENGLISH/TAMIL speaking). If the score is 4 and above and IQ above 90 and Medical fitness given by treating Oncologist to undergo Cognitive behavior therapy and or Art based therapy, the other baseline assessments – Automatic thoughts, Anxiety, Depression and Quality of life of the child will be assessed.

The eligible samples are randomly assigned by the Biostatistics department for Intervention. Random assignment of 93 children with cancer in the Intervention Arm – 1 (Cognitive Behavior Therapy - 40 minutes) and 93 children with cancer in the Intervention Arm – 2 (Cognitive Behavior and Art Based Therapy - 20 + 40 minutes with break) alternatively as per the admissions over the period of data collection.

The CBT module is based on Aaron Beck & Judith Beck Model (derived from Beck model by the Investigator, a clinical psychologist) and Art based Therapy is based on Cathy Malchiodi techniques (helped by Art Therapist to develop the Art based therapy module ). Each child is given 6 intervention sessions lasting for 40 to 60 minutes one-to-one over a period of 1 month.

Post intervention, after a week, the Psycho-oncologist will do the post assessment of distress, Automatic thoughts, Anxiety, Depression and Quality of life. One month and 6 months post intervention a follow-up assessment is done along with focus group discussion.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Investigator Blinded

入排标准

年龄范围
8.00 Year(s) 至 18.00 Year(s)(—)
性别
All

入选标准

  • Medical fitness by Oncologist to undergo CBT and Art based therapy IQ above 90 Distress score 4 and above Tamil and or English speaking.

排除标准

  • Labelled as Medical unfit by Oncologist to undergo CBT and Art based therapy IQ below 90 Distress score below 4 Other than Tamil and or English speaking.

结局指标

主要结局

To assess the level of Distress, Anxiety, Depression, Automatic thoughts and Quality of life among children with cancer

时间窗: One week post intervention | One month post intervention | Six months post intervention

次要结局

  • To understand the types of Automatic thoughts among children with cancer with respect to the diagnosis and treatment(One week post intervention)
  • To understand the relationship between Automatic thoughts, Distress, Anxiety, Depression, and Quality of life among children with cancer(One week post intervention)
  • To compare the effectiveness of Cognitive Behaviour Therapy with Integrated Cognitive Behaviour and Art based therapy in reducing Automatic thoughts, Distress, Anxiety, Depression and enhancing Quality of life among children with cancer(One week post intervention)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Kavitha Dhanaraj

University of Madras

研究点 (1)

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