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

NCT ID: NCT03605732

Last Updated: 2019-09-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 312 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-01
• Study Completion Date: 2019-06-08

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.

Conditions

Insomnia; Behavioral Intervention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

intervention

Intervention group: They will receive an educational app designed to improve sleep, and will receive self-help training in a six-week training package.

Group Type: EXPERIMENTAL

self help sleep hygiene intervention application

Intervention Type: 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.

Patient education

Patients will receive written weekly information on accurate and relevant information regarding insomnia symptoms, physiological controls of sleep, sleep hygiene practices, healthy sleep behaviors

Group Type: ACTIVE_COMPARATOR

patients education

Intervention Type: 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

Interventions

self help sleep hygiene intervention application

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.

Intervention Type: BEHAVIORAL

patients education

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qazvin University Of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Amir H Pakpour

Supervisor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Qazvin University of Medical Sciences

Qazvin, , Iran

Countries

Iran

References

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.

Reference Type: DERIVED

PMID: 32234700 (View on PubMed)

Other Identifiers

IR.QUMS.REC.1396.455

Identifier Type: -

Identifier Source: org_study_id