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

NCT03605732 | Completed DMC

• 1 other identifier: IR.QUMS.REC.1396.455
• Study Type: interventional
• Target: 312
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Sleep Quality

  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

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

• sleep hygiene behavior

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

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

Secondary Outcomes (2)

• Anxiety and Depression

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

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

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

Study Arms (2)

intervention

EXPERIMENTAL

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

Behavioral: self help sleep hygiene intervention application

Patient education

ACTIVE COMPARATOR

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

Other: patients education

Interventions

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.

intervention

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

Patient education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Qazvin University Of Medical Sciences: lead

Study Sites (1)

Qazvin University of Medical Sciences

Qazvin, 3419759811, Iran

Location

Related Publications (1)

• 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.

  PMID: 32234700 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Patient Education as Topic

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Supervisor

Study Record Dates

• First Submitted: July 22, 2018
• First Posted: July 30, 2018
• Study Start: June 1, 2018
• Primary Completion: April 6, 2019
• Study Completion: June 8, 2019
• Last Updated: September 4, 2019

Record last verified: 2019-09

Locations

IR (1)