Brief internet-delivered intervention for insomnia among health care workers and nursing staff
| ISRCTN | ISRCTN36198096 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN36198096 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | IR.LUMS.REC.1399.269 |
| Sponsor | Lorestan University |
| Funder | Investigator initiated and funded |
- Submission date
- 22/05/2022
- Registration date
- 24/05/2022
- Last edited
- 25/06/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Insomnia means you regularly have problems sleeping. It is particularly common among healthcare workers. Cognitive Behavioral Therapy for Insomnia (CBT-I) is established as the best available treatment. However, very few patients with insomnia receive this treatment. One potential way of improving the dissemination of CBT-I is by using online adaptations of CBT-I. This is a new method for delivering CBT-I and it is not known how effective online treatment is compared to face-to-face CBT-I. This trial's purpose is to compare internet-delivered Mindfulness-based stress reduction with online CBT-I. Because of the great advantage of online treatment in both availability and cost, the trial is designed as a noninferiority trial.
Who can participate?
Nurses who actively worked during the pandemic are targeted in the study.
What does the study involve?
Participants will be randomly allocated to receive 6 sessions of mindfulness training or an online CBT-I course for approximately 6 weeks. Participants will be followed up after 3 months.
What are the possible benefits and risks of participating?
The improvement in sleep quality is the most important benefit in this study. Nurses who learn the skills related to insomnia treatment will also be able to reduce the patients’ insomnia and sleep problems. The interventions are classified as safe.
Where is the study run from?
Lorestan University (Iran)
When is the study starting and how long is it expected to run for?
January 2021 to September 2022
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Nabi Nazari, nnpilotiriaf@gmail.com
Contact information
Scientific
Lorestan University
Khorramabad
65065
Iran
 ORCID ID |
0000-0003-3771-3699 |
|---|---|
| Phone | +98 66986756 |
| Nnpilotiriaf@gmail.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | An internet-delivered two-arm assessor-blinded parallel-group randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Mindfulness-based therapy for insomnia in nursing staff: a non-inferiority internet-delivered, randomized controlled trial |
| Study acronym | iMBSR |
| Study objectives | An internet-delivered, two-arm, accessor-blinded, parallel group randomized controlled trial design will be used to examine the impact of CBT-I compared to MBSR among a sample |
| Ethics approval(s) | Approved 12/01/2021, Lorestan Research Ethics Committee (Lorestan University of Medical Sciences, Anooshirvan Rezaei Square, Khorramabad, Lorestan, Iran, 6813833946; +98 6633302033; publicrelation@lums.ac.ir), ref: |
| Health condition(s) or problem(s) studied | Insomnia |
| Intervention | The study will be a randomized, controlled trial of internet-based cognitive behavioral therapy (iCBT) vs Mindfulness based stress reduction for insomnia Mindfulness group: Session 1: Physiological and psychological response to stress What is mindfulness? Mindfulness history, application and science research Session 2: Brain’s mode of action and existence Session 3: Interpretation of insomnia Session 4: Interpretation of thoughts Interpretation of emotions Session 5: Avoidance response Allow emotions Session 6: How to balance our life Seven attitude of mindfulness practices Homework: Meditation practice Mindful breathing meditation Mindful body scan Homework Mindful breathing meditation Bringing mindfulness to daily life Control Group: Participants in the CBT-I group will receive internet-based CBT-I intervention The core contents are designed based on CBT-I: Sleep hygiene education, Individualized sleep restriction, Stimulus control, Relaxation audios (muscle relaxation, breathing exercise, guided imagery, and mindfulness), Cognitive components, information about sleeping pills, and A brief overview. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
Insomnia Severity Index (Total) at pre-intervention, intervention completion (expected average of 6 weeks), 3 months follow up |
| Key secondary outcome measure(s) |
1. Self-reported beliefs and attitudes about sleep measured using the Dysfunctional Beliefs and Attitudes About Sleep Scale from Baseline to Post-Treatment and 3 month follow-up |
| Completion date | 01/09/2022 |
Eligibility
| Participant type(s) | Health professional |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 100 |
| Key inclusion criteria | 1. Aged 18 years or older with no prior experience with CBT-I 2. Willing to participate and were randomly assigned to the control condition 3. Access to the Internet and had an e-mail address |
| Key exclusion criteria | 1. Pregnancy or breastfeeding 2. Clear and current or history of substance dependence disorder or alcohol, and suicide 3. Receive psychotherapy during the period of this study |
| Date of first enrolment | 01/06/2022 |
| Date of final enrolment | 01/07/2022 |
Locations
Countries of recruitment
- Iran
Study participating centre
Khorramabad
65055
Iran
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Stored in publicly available repository |
| IPD sharing plan | Raw data, after it is depersonalized, will be submitted to ISRCTN. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 16/12/2022 | 25/06/2024 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
25/06/2024: Publication reference added.
24/05/2022: Trial's existence confirmed by Lorestan Research Ethics Committee.
