CBT for Insomnia With Anxiety and Depression

Last updated: October 15, 2020
Sponsor: Shanghai Mental Health Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Insomnia

Treatment

N/A

Clinical Study ID

NCT04585282
Chengmei Yuan
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age ≥18 years, male and female

  2. Meet the diagnostic criteria of DSM-5 for insomnia, the Pittsburgh Sleep Quality Index (PSQI) scale total score ≥10

  3. May be accompanied by depression symptoms, but currently does not meet any depressiondisorders diagnostic criteria,14≤HAMD-17≤23

  4. May be accompanied by anxiety symptoms, but currently does not meet any anxietydisorders diagnostic criteria ,14≤HAMA≤29

  5. Have sufficient education and understanding to complete this study to be examined andevaluated

  6. Voluntary participation in this clinical trial and signature of informed consent.

Exclusion

Exclusion Criteria:

  1. DSM-5 other sleep problems, such as apnea syndrome, restless leg syndrome

  2. Women who are pregnant, nursing or planning to become pregnant during the study

  3. Insomnia caused by alcohol or substance abuse

  4. Severe cognitive problems

  5. Patients who were previously or currently diagnosed as bipolar and related disorders,obsessive-compulsive and related disorders, schizophrenia spectrum and other psychoticdisorders, trauma and stress related disorders, separation disorders, eating disorders

  6. Patients with history of epilepsy or other serious somatic diseases

  7. Persons receiving MECT treatment for nearly one month

  8. Excluding those who have received systemic psychotherapy for more than 3 months in arow

  9. The researchers believe that it is not suitable to participate in this clinical study.

Study Design

Total Participants: 180
Study Start date:
August 01, 2020
Estimated Completion Date:
July 31, 2022

Study 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.

Connect with a study center

  • Shanghai Mental Health Center

    Shanghai, Shanghai 200030
    China

    Active - Recruiting

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