Effectiveness of group-delivered therapy for insomnia
| ISRCTN | ISRCTN16185698 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16185698 |
| Secondary identifying numbers | 2021/FOS374023 |
- Submission date
- 13/10/2022
- Registration date
- 17/11/2022
- Last edited
- 14/04/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Nervous System Diseases
Plain English Summary
Background and study aims
Insomnia is the most common sleep disorder in the general population and in clinical practice. It has been linked with an increased risk of adverse health outcomes such as cardiovascular disease, type 2 diabetes, chronic multisite pain, depression and hypertension. However, treatment options for insomnia are limited. Currently, the most common way of treating insomnia is with pharmacotherapy. Pharmacotherapy has been shown to have low-to-moderate effects and is mainly recommended for short-term use, as symptoms often return after treatment. It is therefore recommended to use cognitive behavioral therapy for insomnia (CBT-I) as first-line treatment, due to its long-term effectiveness. However, CBT-I is not widely available due to the lack of trained therapists and long waiting lists in specialist sleep clinics. Since there are limited resources for high-quality individual CBT-I, a group-delivered course for individuals with insomnia symptoms was designed by the Norwegian Directorate of Health. The course is based on core CBT-I principles including sleep hygiene, stimulus control, sleep restriction, cognitive therapy, and relaxation training. An advantage of this course is that it can be delivered to up to 15 individuals at the same time, and may thus complement traditional treatments and relieve pressure on primary care. Although this therapy has already been implemented in several municipalities in Norway, its effectiveness has never been evaluated.
The study aims to test the effectiveness of group-delivered cognitive behavioral therapy for insomnia (CBT-I) in primary healthcare. We will compare participants who received the therapy (intervention group), and those who did not (i.e., waiting list control group). The primary aim is to examine the differential change in insomnia severity at 3 months post-randomization. Secondary aims include:
1. Examine differential changes in health-related quality of life, fatigue, depression/anxiety, and sleep diary data at 3 months post-randomization, and 6 months post-randomization.
2. Examine whether potential treatment moderators (chronotype, reactivity to stress, recruitment location, duration of insomnia, length of insomnia treatment, lifestyle etc.) influence the effectiveness of the group-delivered CBT-I in primary care.
3. Collect national registry data at 1 and 2 years post-randomization to compare sick leave days, use of prescribed medication (psychotropic medications, sedatives) and healthcare resource utilization.
4. Explore mediating analyses to identify mechanisms of change in the primary and secondary outcomes, focusing on psychological measures of beliefs about sleep and sleep-related self-efficacy.
5. Carry out a process evaluation to assess facilitators and barriers for treatment adherence and qualitative studies to explore participants’ experience of group-delivered CBT-I.
Who can participate?
Adults (18 + years old) with symptoms of insomnia (Insomnia Severity Scale of 12 or higher)
What does the study involve?
The study involves either participating in the group-delivered therapy for insomnia (intervention group) or being on a waiting list for 6 months (control group). All participants fill out a questionnaire package and a 7-day sleep diary at 4 measurement time points (weeks 1 and 4, and months 3 and 6).
What are the possible benefits and risks of participating?
For the individual participant, participation in the study provides a good opportunity to survey and improve sleep quality. Overall, the intervention is currently being offered in many Norwegian municipalities, but its effectiveness has not yet been evaluated. Evaluating the effectiveness of the intervention will strengthen the treatment of insomnia in primary care. In addition, data from the project will be used to further develop the intervention in collaboration with the Directorate of Health and sleep experts in Norway.
By taking part in the study, the participants devote time and attention to questions about health and illness, which can cause unnecessary worries. Nevertheless, these are people who already have a sleep problem and wish to treat it, and we do not consider this a major risk. Moreover, certain participants may feel concerned that their sleep and health are being carefully surveyed during the duration of the study. It is specified that all data is anonymous and that no revealing or private data will be used. Participants who are randomized to the control group end up on a waiting list for the intervention and have to wait up to 6 months before they are offered to participate in a sleep course.
Where is the study run from?
Norwegian University of Science and Technology (Norway)
When is the study starting and how long is it expected to run for?
January 2022 to December 2025
Who is funding the study?
Norwegian Foundation for Health and Rehabilitation (ExtraStiftelsen, Stiftelsen Dam & Dam Foundation) (Norway)
Who is the main contact?
Maria Hrozanova (Principal Investigator) (Norway)
maria.hrozanova@ntnu.no
Contact information
Principal Investigator
Mauritz Hansens gate 2
Trondheim
7030
Norway
 ORCID ID |
0000-0002-1309-489X |
|---|---|
| Phone | 004741011848 |
| maria.hrozanova@ntnu.no |
Scientific
Øya Helsehus 5etg
St. Olavs Hospital
Mauritz Hanssens gate 2
Trondheim
7030
Norway
| ORCID ID |
0000-0002-4135-0408 |
|---|---|
| Phone | +47 97521297 |
| eivind.s.skarpsno@ntnu.no |
Scientific
Øya Helsehus 5etg.
St. Olavs Hospital
Mauritz Hanssens gate 2
Trondheim
7030
Norway
| ORCID ID |
0000-0002-3228-1236 |
|---|---|
| Phone | +47 90066915 |
| ingebrigt.meisingset@ntnu.no |
Study information
| Study design | Multicenter interventional unblinded pragmatic randomized control trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community |
| Study type | Treatment |
| Participant information sheet | 42598 Poster for recruitment.jpeg |
| Scientific title | Group-delivered cognitive behavioral therapy for insomnia in primary care: A pragmatic, multicenter randomized controlled trial |
| Study hypothesis | Participants in the intervention group, who receive 4 sessions of group-delivered cognitive behavioral therapy for insomnia will experience a greater reduction of insomnia symptoms and improved health-related quality of life than the wait-list control group. |
| Ethics approval(s) | Approved 21/06/2022, Regional Ethics Committee in Mid-Norway (NTNU/REK midt, Det medisinske fakultet, Postboks 8905, 7491 Trondheim, Norway; +47 73 59 75 11; rek-midt@mh.ntnu.no), ref: 46524 |
| Condition | Insomnia |
| Intervention | Current interventions as of 13/12/2023: Due to natural capacity limitations, some intervention group participants may have to wait to begin treatment. Waiting times over 2-3 months rarely occur. The last self-reported measurements are expected to be sent out by December 31st 2023. Thus, the data collection is expected to be finalized by January 15th 2024 at the latest. All participants are self-referred to the study. Recruitment occurs primarily on social media (advertisements on Facebook) and through the Healthy Life Centres participating in this trial, and secondarily through information posters displayed in relevant places (e.g., GP or physiotherapy offices). Each adult interested in participating fills out a screening questionnaire, which can be found on the trial website www.sovnbehandling.no. Participants who fulfil the criteria for inclusion are sent a digital consent form with detailed information about trial participation. Those who return the signed consent form are randomized in the centre they participate. There are two trial arms: Intervention group – participation in 4 sessions of group-delivered CBT-I. Group sizes vary from 5-15 depending on the capacity of the Healthy Life Centre. Employees deliver the intervention at the participating Healthy Life Centres (mostly physiotherapists). The intervention has been developed by the Norwegian Directorate of Health, in collaboration with the National competence centre for sleep disorders, the Public health institute and the Norwegian association for cognitive therapy. The intervention group is actively followed up for 6 months (self-reported questionnaires), and after that for 2 years (register data). Control group – waiting list of 6 months. During the waiting period, participants fill out the same self-reported questionnaires as the intervention group. They are not offered any treatment during the 6-month waiting period. They are not prohibited from taking sleep medication at this time or seeking other forms of treatment (whether they received any treatment during their participation will be investigated at the 6-month assessment point). Control group participants are contacted once, upon randomization, by the Healthy Life Centre in their municipality, to offer them the possibility to participate in the intervention after the 6-month waiting period is finalized. Previous interventions: All participants are self-referred to the study. Recruitment takes place primarily on social media (advertisements on Facebook) and through the Healthy Life Centres that are participating in this trial, and secondarily through information posters displayed in relevant places (e.g., GP or physiotherapy offices). Each adult interested in participating fills out a screening questionnaire, which can be found on the trial website www.sovnbehandling.no. Participants who fulfil the criteria for inclusion are sent a digital consent form which has detailed information about trial participation. Those who return the signed consent form are randomized in the centre they participate in. There are two trial arms: Intervention group – participation in 4 sessions of group-delivered CBT-I. Group sizes vary from 5-15 depending on the capacity of the Healthy Life Centre. Employees deliver the intervention at the participating Healthy Life Centres (mostly physiotherapists). The intervention has been developed by the Norwegian Directorate of Health, in collaboration with the National competence centre for sleep disorders, the Public health institute and the Norwegian association for cognitive therapy. The intervention group is actively followed up for 6 months (self-reported questionnaires), and after that for 2 years (register data). Control group – waiting list of 6 months. During the waiting period, participants fill out the same self-reported questionnaires as the intervention group. They are not offered any treatment during the 6-month waiting period. They are not prohibited from taking sleep medication at this time or seeking other forms of treatment (whether they received any treatment during their participation will be investigated at the 6-month assessment point). Control group participants are contacted once, upon randomization, by the Healthy Life Centre in their municipality, to offer them the possibility to participate in the intervention after the 6-month waiting period is finalized. |
| Intervention type | Behavioural |
| Primary outcome measure | Insomnia measured using the Insomnia Severity Index at baseline, 4 weeks, 3 months (primary measurement point), and 6 months |
| Secondary outcome measures | 1. At baseline, 4 weeks, 3 months (primary measurement point), and 6 months, all participants fill out the following secondary outcome measures: 1.1. Fatigue measured using the Chalder Fatigue Scale 1.2. Subjective sleep patterns measured using a 7-day digital sleep diary 1.3. Health-related quality of life measured using EuroQol EQ5D-5L 1.4. Mental distress measured using the Hopkins Check List 1.5. Chronotype measured using Brief Horne-Østberg Morningness-Eveningness questionnaire 1.6. Patient beliefs and attitudes about sleep measured using Dysfunctional Beliefs and Attitudes about Sleep questionnaire 1.7. Sleep reactivity measured using Ford Insomnia Response to Stress Test 2. At baseline, intervention group participants fill out the following secondary outcome measures: 2.1. Motivation for treatment measured using Nijmegen Motivation List 2 2.2. Treatment expectancy measured using Credibility/Expectancy Questionnaire 3. At 3 months, intervention group participants fill out the following secondary outcome measures: 3.1. Utility of CBT-I measured using Treatment Components Adherence Scale 4. Participant demographic information measured using a questionnaire at baseline 5. At 12 months and 24 months the following outcomes will be measured: 5.1. Short - and medium-term impact of group-delivered CBT-I on rates of sick leave, and medication and health resource utilization measured by accessing national health registry data 5.2. Overview of health service utilization measured by obtaining data from the Norwegian Patient Registry 5.3. Overview of prescribed medication measured by obtaining data from the Norwegian Prescription Database 5.4. Information on sick leave measured by obtaining data from the National Insurance Administration |
| Overall study start date | 01/01/2022 |
| Overall study end date | 31/12/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 300 |
| Total final enrolment | 309 |
| Participant inclusion criteria | Inclusion criteria based on self-report and national registries: 1. Adults older than 18 years of age 2. Self-referred to the study 3. Insomnia Severity Index score of 12 or higher |
| Participant exclusion criteria | Exclusion criteria based on self-report: 1. Bipolar disorder 2. Schizophrenia or other psychotic disorders 3. Personality disorders 4. Dementia and other neurodegenerative disorders 5. Heart surgery within the last 3 months 6. Untreated sleep apnea 7. Undergoing cancer treatment at the screening timepoint 8. Multiple sclerosis with an attack at screening timepoint 9. Adults without adequate skills in the Norwegian language to participate in the group-delivered course |
| Recruitment start date | 20/08/2022 |
| Recruitment end date | 31/05/2023 |
Locations
Countries of recruitment
- Norway
Study participating centres
Sandnessjøen
8800
Norway
Arendal
4848
Norway
Asker
1386
Norway
Bodø
8008
Norway
Kråkerøy
1671
Norway
Nøtterøy
3120
Norway
Fåberg
2625
Norway
Ålgård
4330
Norway
Hamar
2319
Norway
Helgelandsmoen Næringspark
Røyse
3530
Norway
Sande
3070
Norway
Inderøy
7670
Norway
Kristiansand
4630
Norway
Mandal
4514
Norway
Gullbringvegen 34
Bø
3800
Norway
Geithus
3360
Norway
Dilling
1570
Norway
Notodden
3674
Norway
Oslo
0872
Norway
Fåvang
2634
Norway
Hønefoss
3510
Norway
Skien
3717
Norway
Steinkjer
7725
Norway
Tromsø
9008
Norway
Smistadveien 13
Trondheim
7026
Norway
Verdal
7650
Norway
Sponsor information
University/education
Høgskoleringen 1
Trondheim
7034
Norway
| Phone | +47 73 59 50 00 |
|---|---|
| ism-post@mh.ntnu.no | |
| Website | http://www.ntnu.edu |
"ROR" |
https://ror.org/05xg72x27 |
Funders
Funder type
Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Norwegian Foundation for Health and Rehabilitation, EkstraStiftelsen Helse og Rehabilitering, ExtraStiftelsen, Stiftelsen Dam & Dam Foundation
- Location
- Norway
Results and Publications
| Intention to publish date | 31/12/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | 1. Planned publication in a high-impact peer-reviewed journal. 2. Participation in national and international scientific conferences 3. Results will be disseminated in Norwegian knowledge bases and at meetings/seminars organized by user organizations such as Mental Health. 4. Share a summary of the project with relevant user organizations, health blogs and websites. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made publicly available due to participant confidentiality and considerations relating to data security. Participant-level data can be made accessible to specific users by contacting the project leader. The users must then be registered with the regional Medical Ethical Committee, in Norway. The need for restrictions may change over time, allowing the data to be made accessible at a later point. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 24/10/2022 | No | Yes | ||
| Protocol article | protocol | 02/03/2023 | 03/03/2023 | Yes | No |
| Statistical Analysis Plan | version 1 | 25/01/2024 | 19/02/2024 | No | No |
| Statistical Analysis Plan | version 2 | 06/03/2024 | 08/03/2024 | No | No |
| Statistical Analysis Plan | version 3 | 10/04/2024 | 15/04/2024 | No | No |
| Results article | 02/04/2025 | 14/04/2025 | Yes | No |
Additional files
Editorial Notes
14/04/2025: Publication reference added.
15/04/2024: Statistical analysis plan version 3 uploaded. Total final enrolment added.
08/03/2024: Statistical analysis plan version 2 uploaded.
19/02/2024: Statistical analysis plan uploaded.
13/12/2023: The interventions were changed.
05/06/2023: The recruitment end date was changed from 31/12/2023 to 31/05/2023.
03/03/2023: Publication reference added.
24/10/2022: Trial's existence confirmed by the ethics committee for the Norwegian University of Science and Technology, Department of Community Medicine and Nursing.
