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

Primary Purpose

Insomnia, Behavioral Intervention

Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
self help sleep hygiene intervention application
patients education
Sponsored by
Qazvin University Of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Qazvin University of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

intervention

Patient education

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
July 22, 2018
Last Updated
September 2, 2019
Sponsor
Qazvin University Of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03605732
Brief Title
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

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
April 6, 2019 (Actual)
Study Completion Date
June 8, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Qazvin University Of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia, Behavioral Intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
312 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intervention
Arm Type
Experimental
Arm Description
Intervention group: They will receive an educational app designed to improve sleep, and will receive self-help training in a six-week training package.
Arm Title
Patient education
Arm Type
Active Comparator
Arm Description
Patients 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
Behavioral
Intervention Name(s)
self help sleep hygiene intervention application
Intervention Description
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
Other
Intervention Name(s)
patients education
Intervention Description
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 Outcome Measure Information:
Title
Sleep Quality
Description
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
Time Frame
changes in PSQI baseline , 1 month, 3 months and 6 months follow-up
Title
sleep hygiene behavior
Description
Sleep hygiene behaviour will use three items to measure how many days the participants had good sleep hygiene. behaviour.
Time Frame
changes in sleep hygiene behavior baseline , 1 month, 3 months and 6 months follow-up
Secondary Outcome Measure Information:
Title
Anxiety and Depression
Description
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.
Time Frame
changes in Anxiety and Depression baseline , 1 month, 3 months and 6 months follow-up
Title
Psychological predictors of sleep hygiene behavior (intention, planning, outcome expectancies,Habit,Self-monitoring,Self-efficacy)
Description
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.
Time Frame
changes from baseline , changes from baseline , 1 month and 6 Months follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Qazvin University of Medical Sciences
City
Qazvin
ZIP/Postal Code
3419759811
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
32234700
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.
Results Reference
derived

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

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