跳至主要内容
临床试验/CTRI/2023/08/056414
CTRI/2023/08/056414招募中不适用

The effectiveness of brief cognitive behavioural therapy on psychological distress among the elderly population undergoing orthopaedic surgery

Founder Chancellor Shri NPV Ramasamy Udayar Research Fellowship SRIHER1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年8月18日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
The anticipated outcome from this study would be to see a reduction of the intensity of Depression, Anxiety & Stress through the use of B-CBT that was caused by Psychological distress through surgery.

研究概览

简要总结

the research is focused on the elderly who are above the age of 55 and are admitted for orthopaedic surgery at sri ramachandra hospital will be admitted to the study.

the admission process will happen within 24-48 hours of the patient arriving at the hospital. the researcher will utilise questionnaires such as Montreal cognitive assessment and DASS 21 on the patient. the MoCA is a test of cognitive function and a score of 26 and above is preferred,  the DASS 21 is a test of current levels of depression, anxiety and stress in the patient in which a score of 10 in Depression OR 8 in Anxiety OR 15 in Stress and above is preferred, MoCA will be administered once to determine eligibility in the study, DASS21 will be utilised twice during the course of the study, once at the beginning and once at the end of 7 sessions, Barthel’s index is a test of performance of daily living. this is done to measure mobility levels post surgery in both the groups to see which group scores highest.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

年龄范围
60.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • •Elderly population aged 60 years and above.
  • •Closed musculoskeletal trauma Obtain a score of 20 in Depression, 14 in Anxiety and 25 in Stress in the DASS 21 scale and a score of 26 above in the MoCA scale.
  • •Able to read and write Tamil or English.
  • •Willing to participate in the study.

排除标准

  • •Congenital absence of limb(s) Birth defects Open and pathological fractures Musculoskeletal and neuromuscular disorders Presence of cerebrovascular accident Having neurological deficits such as dementia, Alzheimer’s disease, Parkinson’s disease etc Presence of schizophrenia or other psychotic disorder based on medical record or patient self report.
  • •Already undergoing another form of psychotherapy Those who have difficulty maintaining follow up ( E.g living far away from the hospital, transportation issues etc.) Poly trauma with head injury.

结局指标

主要结局

The anticipated outcome from this study would be to see a reduction of the intensity of Depression, Anxiety & Stress through the use of B-CBT that was caused by Psychological distress through surgery.

时间窗: the scales will be administered once within 24-48 hours of admission & then at the end of 7 weeks in the seventh outcome assessor session.

To report the treatment effectiveness of B-CBT for elderly participants with PD.

时间窗: the scales will be administered once within 24-48 hours of admission & then at the end of 7 weeks in the seventh outcome assessor session.

To report an increase in the Barthels index score in the experimental group as a result of B-CBT.


时间窗: the scales will be administered once within 24-48 hours of admission & then at the end of 7 weeks in the seventh outcome assessor session.

次要结局

  • To report an increase in the Barthels index score in the experimental group as a result of B-CBT.
(This will be measured at the end of 7th session.)

研究者

发起方
Founder Chancellor Shri NPV Ramasamy Udayar Research Fellowship SRIHER
申办方类型
Research institution

研究点 (1)

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