Clinical trial NCT03605732: The Effectiveness of an Educational Intervention Based on Self-help for Sleep Hygiene Promotion on Patients With Insomnia
Official title: The Effectiveness of an Educational Intervention Based on Self-help for Sleep Hygiene Promotion on Employees of Qazvin University of Medical Sciences
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Behavioral Intervention
Lead sponsor: Qazvin University Of Medical Sciences
Sponsor class: OTHER
First posted: 2018-07-30
Enrollment: 312
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Sleep Quality
timeFrame: changes in PSQI baseline , 1 month, 3 months and 6 months follow-up
measure: sleep hygiene behavior
timeFrame: changes in sleep hygiene behavior baseline , 1 month, 3 months and 6 months follow-up
Secondary outcomes:
measure: Anxiety and Depression
timeFrame: changes in Anxiety and Depression baseline , 1 month, 3 months and 6 months follow-up
measure: Psychological predictors of sleep hygiene behavior (intention, planning, outcome expectancies,Habit,Self-monitoring,Self-efficacy)
timeFrame: changes from baseline , changes from baseline , 1 month and 6 Months follow-up
Other outcomes:
Locations:
city: Qazvin
country: Iran, Islamic Republic of
facility: Qazvin University of Medical Sciences
Study officials:
References:
citation: Rajabi Majd N, Brostrom A, Ulander M, Lin CY, Griffiths MD, Imani V, Ahorsu DK, Ohayon MM, Pakpour AH. Efficacy of a Theory-Based Cognitive Behavioral Technique App-Based Intervention for Patients With Insomnia: Randomized Controlled Trial. J Med Internet Res. 2020 Apr 1;22(4):e15841. doi: 10.2196/15841.