NCT04585282

CBT for Insomnia With Anxiety and Depression

A Randomized Controlled Study of Cognitive Behavioral Therapy for Insomnia With Anxiety and Depression

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Shanghai Mental Health Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Insomnia

Interventions

Type	Name	Description
BEHAVIORAL	Plus Cognitive behavioral therapy of insomnia（CBT-I plus）	Cbt-i plus program is an enhanced version of cbt-i program, which increases the response to depression and anxiety symptoms.
BEHAVIORAL	Cognitive behavioral therapy of insomnia（CBT-I）	Cognitive behavioral therapy of insomnia is mainly aimed at correcting the bad behaviors and beliefs among the maintenance factors of insomnia, which is considered as the first-line treatment program of insomnia disorder. Cognitive behavioral therapy of insomnia mainly includes five important components: sleep restriction, secondary control, cognitive therapy, relaxation therapy and sleep hygiene.

Timeline

• Start date: 2020-08-01
• Primary completion: 2022-04-30
• Completion: 2022-07-31
• First posted: 2020-10-14
• Last updated: 2020-10-19

Locations

1 site across 1 country: China