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Clinical Trial Summary

Objective to explore whether cbt-i plus is more effective and feasible for patients with insomnia complicated with anxiety and depression than the traditional cognitive behavioral therapy for insomnia. Hypothesis: cbt-i plus is superior to cbt-i in efficacy and feasibility.


Clinical Trial Description

The purpose of this study was to explore the treatment of cognitive behavioral enhancement of insomnia (cbt-i plus), which was randomly divided into cbt-i plus intervention group (Study Group) and cbt-i intervention group (control group). The study group used the unified cognitive behavioral therapy manual for insomnia (cbt-i plus) for one-to-one individual treatment intervention, once a week, 45-50 minutes each time, a total of 8 times; the control group used the unified cognitive behavioral therapy manual for insomnia (cbt-i) for one-on-one treatment intervention, once a week, 45-50 minutes each time, a total of 8 times. The related indexes were evaluated at baseline, 2 weeks, 4 weeks and 8 weeks after enrollment, and were followed up at 12 weeks and 24 weeks after enrollment. Hypothesis: cbt-i plus is superior to cbt-i in efficacy and feasibility. ;


Study Design


Related Conditions & MeSH terms

  • Insomnia
  • Sleep Initiation and Maintenance Disorders

NCT number NCT04585282
Study type Interventional
Source Shanghai Mental Health Center
Contact Chengmei Yuan
Phone 86-13818132592
Email yuanchengmei@yeah.net
Status Recruiting
Phase N/A
Start date August 1, 2020
Completion date July 31, 2022

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