Behavioral Treatment for Insomnia

Not Applicable

Recruiting

• Conditions: F00-F99; Insomnia, Sleep Initiation and Maintenance Disorders

• Registration Number: RBR-7nc5wq
• Lead Sponsor: Hospital das Clinicas da Faculdade de Medicina da USP

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-08-16
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Present one or more of the following symptoms with a frequency of three or more nights per week, with persistence for at least one month: Sleep onset latency greater than or equal to 30 minutes; Time agreed upon falling asleep or equal to or greater than 30 minutes; Early awakening at least 30 minutes earlier than desired; Non-restorative sleep complaint despite favorable circumstances for sleep.

Exclusion Criteria

Non-stabilized clinical or psychiatric comorbidities; Use of illicit drugs and alcohol; Illiteracy and cognitive disorders.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement of sleep evaluated by the reduction in Insomnia Severity Index scores, based on a significance level of 0.05 for pre and post-treatment comparisons and in comparison with the control group.

Secondary Outcome Measures

Name	Time	Method
Improvement in the emotional state evaluated by the reduction in the scores of the Hospital Anxiety and Depression Scale, based on a significance level of 0.05 for pre and post-treatment comparisons and in comparison with the control group.;Increased psychological flexibility assessed by the reduction in Acceptance and Action Questionnaire-II scores, based on a significance level of 0.05 for pre and post-treatment comparisons and compared with the control group.;Reduction of dysfunctional beliefs about sleep assessed by the reduction in Dysfunctional Beliefs and Attitudes about Sleep scores, based on a significance level of 0.05 for pre and post-treatment comparisons and in comparison with the control group.