InsomniaNCT03605732
The Effectiveness of an Educational Intervention Based on Self-help for Sleep Hygiene Promotion on Patients With Insomnia
A study testing self help sleep hygiene intervention application and patients education in people with Insomnia and Behavioral Intervention, run by Qazvin University Of Medical Sciences at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia, Behavioral Intervention
- What is being tested?
- self help sleep hygiene intervention application and patients education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 312 participants
- Where
- 1 siteIran
- Study dates
- 1 Jun 2018to 8 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of an Educational Intervention Based on Self-help for Sleep Hygiene Promotion on Employees of Qazvin University of Medical Sciences
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
- Being tested
- self help sleep hygiene intervention application, patients education
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self help sleep hygiene intervention applicationBehavioural
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 educationOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: patients education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: changes in sleep hygiene behavior baseline , 1 month, 3 months and 6 months follow-up
Secondary outcomes (2)
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.
Measured: 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)
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.
Measured: changes from baseline , changes from baseline , 1 month and 6 Months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2018
- Study start1 Jun 2018
- Primary completion6 Apr 2019
- Study completion8 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 312 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qazvin University Of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amir H Pakpour, Qazvin University Of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03605732
- Sponsor's protocol ID
- IR.QUMS.REC.1396.455
- Status last verified
- Sep 2019
- First submitted
- 22 Jul 2018
- Last updated
- 4 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32234700
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of an Educational Intervention Based on Self-help for Sleep Hygiene Promotion on Employees of Qazvin University of Medical Sciences
- ClinicalTrials.gov ID
- NCT03605732
- Acronym / sponsor ID
- IR.QUMS.REC.1396.455
- Conditions
- Insomnia, Behavioral Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 312 participants (actual)
- Lead sponsor
- Qazvin University Of Medical SciencesUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 6 Apr 2019 (actual)
- Study completion
- 8 Jun 2019 (actual)
- First posted
- 30 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Behavioral: self help sleep hygiene intervention applicationIntervention group: They will receive an educational app designed to improve sleep, and will receive self-help training in a six-week training package. |
| Patient education | Active comparator | Other: patients educationPatients will receive written weekly information on accurate and relevant information regarding insomnia symptoms, physiological controls of sleep, sleep hygiene practices, healthy sleep behaviors |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| self help sleep hygiene intervention applicationThis 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. | Behavioural | intervention |
| patients educationParticipants 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 | Other | Patient education |
Primary outcome
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
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.
2 secondary outcomes
Anxiety and Depression
Time frame: 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)
Time frame: changes from baseline , changes from baseline , 1 month and 6 Months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2019.
- Derived from this study: PubMed 32234700Rajabi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing self help sleep hygiene intervention application and patients education in people with Insomnia and Behavioral Intervention, run by Qazvin University Of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Quality (time frame: changes in PSQI baseline , 1 month, 3 months and 6 months follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03605732, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2019; AzTrials last refreshed its copy on 28 Oct 2026.