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NCT Number: NCT03605732

The Effectiveness of an Educational Intervention Based on Self-help for Sleep Hygiene Promotion on Patients With Insomnia

This plan will be implemented on the staff of the Qazvin University of Medical Sciences. The Insomnia Severity Index questionnaire will be used to screen for insomnia and low sleep health. This questionnaire is provided online to the staff through communication channels such as telegrams to help people who are interested in participating in this research. Individuals who scored more than 8 were randomly assigned to intervention and control groups and completed the Insomnia Index Index. The intervention group will then receive an app-based educational intervention designed to improve sleep hygiene. Control group: Participants in the control group perform routine activities. The intervention and control group will fill out the relevant questionnaire one and three and six months after the completion of the training to assess the impact of the intervention online.

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Key information

Conditions

Insomnia Behavioral Intervention Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Qazvin University of Medical Sciences

Qazvin, 3419759811, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical level of Insomnia (more than 10 on ISI)
  • Meets criteria for Insomnia according to DSM-IV-TR
  • Enough language skills
  • Have access to an Android smartphone or a desktop computer with Internet access
  • Participants will be required to sign an informed consent form

Exclusion criteria

  • Uncontrolled medical condition suspected to interfere with sleep or requiring immediate treatment outside of the study
  • Alcohol/drugs abuse
  • Participation in other trials concurrently
  • pregnancy
  • having children under 2 years old
  • Not having an internet-connected computer, cellular phone or tablet
  • Working night shifts
  • Somatic or psychiatric conditions requiring acute care

Treatment and study plan

self help sleep hygiene intervention application

Behavioral

This intervention lasts for six weeks. The intervention is App-based and mainly consists of the most potent CBT techniques as well Health action process approach. Weekly feedback is provided by health psychologists.

patients education

Other

Participants in the PE group will receive written weekly information on accurate and relevant information regarding insomnia symptoms, physiological controls of sleep, sleep hygiene practices, healthy sleep behaviors

Primary outcomes

  1. Sleep Quality

    Time frame: changes in PSQI baseline , 1 month, 3 months and 6 months follow-up

    The Pittsburgh Sleep Quality Index includes seven components of subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, the use of sleep medications and day time dysfunctions provide a total score of these seven components that allows us to better understand the quality and quantity of one's sleep. The Pittsburgh Sleep Quality Index is a self-reporting instrument consisting of nine questions designed to measure the quality of sleep disorders in a period of one month. The scale scores range from 0 to 21, with higher scores indicating poor quality of sleep and scores less than 5 considered as high quality of sleep

  2. sleep hygiene behavior

    Time frame: changes in sleep hygiene behavior baseline , 1 month, 3 months and 6 months follow-up

    Sleep hygiene behaviour will use three items to measure how many days the participants had good sleep hygiene.

    behaviour.

Secondary outcomes

  1. Anxiety and Depression

    Time frame: changes in Anxiety and Depression baseline , 1 month, 3 months and 6 months follow-up

    Zigmond and Snaith developed the 14-item HADS to measure the anxiety (7 items) and depression (7 items) of patients with both somatic and mental problems. The response descriptors of all items are Yes, definitely (score 3); Yes, sometimes (score 2); No, not much (score 1); No, not at all (score 0); except for items 7 and 10, which are scored reversely. A higher score represents higher levels of anxiety and depression: a domain score of 11 or greater indicates anxiety or depression; 8-10 indicates borderline case; 7 or lower indicates no signs of anxiety or depression. The two-factor framework of the HADS has been supported in cancer patients.

  2. Psychological predictors of sleep hygiene behavior (intention, planning, outcome expectancies,Habit,Self-monitoring,Self-efficacy)

    Time frame: changes from baseline , changes from baseline , 1 month and 6 Months follow-up

    psychological predictors of sleep hygiene behavior will be assessed using a using a self-reported measure. All items are rated on a Likert-type scale, ranging from 1 to 5.

Sponsors and collaborators

Lead sponsor

Qazvin University Of Medical Sciences

Other

Registry information

Official study title

The Effectiveness of an Educational Intervention Based on Self-help for Sleep Hygiene Promotion on Employees of Qazvin University of Medical Sciences

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 30, 2018
Registry last updated
Sep 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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