InsomniaNCT04975776
Sleep Restriction Therapy for Insomnia in Primary Health Care
A study testing Sleep restriction therapy and Sleep hygiene in people with Insomnia, run by Region Stockholm at 1 site in Sweden.
Trial summary
The recommended treatment for insomnia, cognitive behavioral therapy for insomnia (CBT-I), is effective. However, its long, multi-component nature makes it challenging to implement in ordinary primary care, where most people are treated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia
- What is being tested?
- Sleep restriction therapy and Sleep hygiene
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteSweden
- Study dates
- 1 Feb 2022to 30 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Fulfills the DSM-5 diagnostic criteria for insomnia disorder: a) Difficulty initiating sleep, difficulty maintaining sleep, and early morning awakenings despite adequate opportunity for sleep (e.g., adequate time and circumstances for sleep and a safe, quiet, and dark bedroom). b) The sleep difficulties cause significant distress or impairment in social, occupational, educational, academic, behavioral, or other important areas of functioning. c) The sleep difficulties occur at least 3 nights per week and have been present for at least 3 months. d) The symptoms are not better explained by and do not occur exclusively during the course of another sleep-wake disorder. e) The symptoms cannot be attributed to the effects of a substance (e.g., drug abuse and medication). f) Coexisting mental disorders and medical conditions do not adequately explain the predominant complaint of insomnia.
Who cannot join
- Severe psychiatric illness (e.g., severe depression, schizophrenia, bipolar disorder)
- Suicidal ideation
- Untreated sleep disorder other than insomnia (e.g., sleep apnea, and restless legs syndrome)
- Epilepsy
- Cognitive disorder
- Pregnancy
Show all 9Show fewer
- Night shift work
- Language difficulties (inability to understand and speak Swedish well enough to participate in the intervention and respond to measurement instruments)
- ≤ 7 points on the Insomnia Severity Index
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sleep Restriction Therapy for Insomnia Delivered as Group Therapy in Primary Health Care: A Randomized Controlled Trial
The recommended treatment for insomnia, cognitive behavioral therapy for insomnia (CBT-I), is effective. However, its long, multi-component nature makes it challenging to implement in ordinary primary care, where most people are treated. An important component of CBT-I is sleep restriction therapy, which may be comparatively easy to carry out in routine primary care. This project tests whether a brief nurse-led group intervention in primary care based on sleep restriction therapy for insomnia reduces insomnia severity and is cost-effective.
Read the detailed description
Background: Insomnia is typically treated in primary health care. The most common treatment is hypnotic drugs, despite their limited and short-term effects, the risk for adverse side effects and dependence, and the fact that CBT-I is the recommended first-line treatment. Reasons may include lack of knowledge about insomnia, a culture of prescribing hypnotics, lack of time during consultations, and a shortage of CBT-I providers. Sleep restriction therapy is one of the core components of CBT-I. It is a behavioral technique that may be feasible to deliver in routine care with existing resources and time constraints.
Objectives: This randomized controlled trial aims to investigate whether brief, behavioral group therapy in primary care based on sleep restriction therapy reduces insomnia severity and is cost-effective. A process evaluation will explore barriers and facilitators for participation and delivery.
Methods: Health care professionals from participating primary health care centers will complete a 1.5-day digital course on assessing patients for insomnia and delivering the intervention. Patients who seek primary health care and meet the study criteria will be randomized to sleep restriction therapy or to receive written sleep hygiene information. Both groups will be free to seek and receive standard care for insomnia. Sociodemographic and clinical characteristics will be collected prior to baseline. Study outcomes include insomnia severity, sleep, daytime symptoms, quality of life, use of hypnotics, sick leave, and work ability. Outcomes will be assessed over a 24-month period. The cost-effectiveness analysis will include the number of insomnia-free days at the 12-month follow-up and quality-adjusted life years. Patient characteristics will be analyzed in relation to adherence, and response. Qualitative explorations of patients and nurses' experiences will be conducted alongside the trial (approximately 15 patients and 15 nurses).
- Conditions
- Insomnia
- Being tested
- Sleep restriction therapy, Sleep hygiene
- Keywords
- Disorders of Initiating and Maintaining Sleep, DIMS, Early Awakening, Awakening, Early, Nonorganic Insomnia, Insomnia, Nonorganic, Primary Insomnia, Insomnia, Primary, Transient Insomnia, Insomnia, Transient, Rebound Insomnia, Insomnia, Rebound, Secondary Insomnia, Insomnia, Secondary, Sleep Initiation Dysfunction, Dysfunction, Sleep Initiation, Dysfunctions, Sleep Initiation, Sleep Initiation Dysfunctions, Sleeplessness, Insomnia Disorder
- 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.
Sleep restriction therapyBehavioural
The intervention includes psychoeducation and sleep restriction therapy, sleep restriction instructions, problem-solving, and support for participants in adjusting sleep restriction instructions to their individual needs and life circumstances. At the final session, participants create an individual plan for maintaining new sleep habits and coping with insomnia relapse. During the intervention, participants are free to seek and receive standard care for insomnia.
Sleep hygieneBehavioural
The control condition will include written, general information about sleep and lifestyle and environmental factors that could improve or disturb sleep. The participants will be free to seek and receive standard care for insomnia.
| Study group | Role | What they receive |
|---|---|---|
| Sleep restriction therapy | Experimental | Four group sessions delivered at the participants' primary health care centers once a week for 3 weeks and again after a 4-week pause. The first session will last for 2 hours and the other sessions for 1 hour. Receives: Behavioral: Sleep restriction therapy |
| Sleep hygiene | Active comparator | Participants in the active comparator group will receive a brochure with sleep hygiene advice from the primary health care center at baseline. Receives: Behavioral: Sleep hygiene |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Insomnia Severity Index (ISI) score
The ISI is a 7-item scale that asesses the severity of sleep disturbance, how much sleep disturbance interferes with daily life and functioning, the noticeability of these impairments to others, worry and distress resulting from sleep disturbance, and general sleep satisfaction/dissatisfaction. Responses are provided on a Likert-scale (0-4). The total score ranges from 0 to 28, and higher scores indicate more severe problems.
Measured: Baseline and 3, 6, 12, and 24 months after baseline
Secondary outcomes (16)
Change in sleep efficiency derived from sleep diary
Sleep efficiency (percentage of time asleep while in bed) will be calculated on the basis of self-reported sleep at each measurement point.
Measured: Baseline and 3, 12, and 24 months after baseline
Change in sleep onset latency derived from sleep diary
Sleep onset latency (time to initiation of sleep after going to bed for the night) will be calculated on the basis of self-reported sleep at each measurement point.
Measured: Baseline and 3, 12, and 24 months after baseline
Change in time awake after sleep onset derived from sleep diary
Time awake after sleep onset calculated on the basis of self-reported sleep at each measurement point.
Measured: Baseline and 3, 12, and 24 months after baseline
Change in number of nocturnal awakenings derived from sleep diary
Number of nocturnal awakenings calculated on the basis of self-reported sleep at each measurement point.
Measured: Baseline and 3, 12, and 24 months after baseline
Change in sleep quality derived from sleep diary
Perceived sleep quality will be calculated on the basis of self-reported sleep at each measurement point. The variable is rated on a Likert scale ranging from 1 to 5. Higher scores indicate better sleep quality.
Measured: Baseline and 3, 12, and 24 months after baseline
Change in Fatigue Severity Scale (FSS) score
The FSS is a 9-item scale that measures the interference of fatigue with daily life. Each item is rated on a scale that ranges from 1 to 7. Higher total scores indicate more severe fatigue.
Measured: Baseline and 3, 12, and 24 months after baseline
Change in the Montgomery-Asberg Depression Rating Scale - self-rating version (MADRS-S) score
MADRS-S includes 9 items that measure the severity of depressive symptoms (mood, feelings of unease, sleep, appetite, ability to concentrate, initiative, emotional involvement, pessimism, and zest for life). Each item includes six statements ranging from the most positive (statement 0) to the least positive (statement 6). The total score ranges from 0 to 54. The higher the score, the more severe the symptoms.
Measured: Baseline and 3, 12, and 24 months after baseline
Changes in the EQ-5D score
EQ-5D is a generic measure of health status that measures quality of life in five health domains: mobility, self-care, daily activities, pain/suffering, and anxiety/depression. The response scale for each domain ranges from no problems (0) to severe problems (3). EQ-5D also includes a visual scale for each theme and for overall health status. Together, the responses form 248 different health profiles, each of which is assigned a point value that makes it possible to compare results.
Measured: Baseline and 3, 12, and 24 months after baseline
Changes in the Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS) score
DBAS measures dysfunctional beliefs and attitudes on an analog scale labeled "strongly disagree" to the left and "strongly agree" to the right. Respondents place a vertical mark at the point on the line that corresponds to degree that they disagree or agree with the statement. The distance (mm) from the left end of the line to the vertical mark is measured and used as the score. Scores range from 0 to 100. Higher scores indicate stronger agreement with the statement.
Measured: Baseline and 3, 12, and 24 months after baseline
Changes in Work Ability Index (WAI) score
The WAI includes seven domains that measure current work ability compared with the lifetime best (0-10 points), work ability in relation to the demands of the job (2-10 points), number of current diseases diagnosed by a physician (1-7 points), estimated work impairment due to diseases (1-6 points), sickness leave during the past year (1-5 points), own prognosis of work ability two years from now (1, 4, or 7 points), and mental resources (1-4 points). The total score ranges from 7 to 49. Higher scores indicate better work ability.
Measured: Baseline, 1 year after baseline, and 2 years after baseline
Changes in Short Form Health Survey-12 (SF- 12) score
The SF-12 includes 12 items that measure health-related quality of life. The number of response alternatives varies by item. An algorithm is used to calculate final scores, which range from 0 to 100. Higher score indicate better quality of life.
Measured: Baseline and 3, 12, and 24 months after baseline
Change in Work and Social Adjustment Scale (WSAS) scores
The WSAI is a 5-item scale that measures functional impairment related to sleep problems. Response alternatives range from 0 (not at all) to 8 (very severely). The total score ranges from 0 to 40. Higher scores indicate more severe impairment.
Measured: Baseline and 3, 12, and 24 months after baseline
Changes in self-reported hypnotic drug use
A questionnaire that measures the frequency (including name and amount taken) of the use of prescribed hypnotics on a Likert scale ranging from never (1) to daily (6). Higher scores indicate more frequent use.
Measured: Baseline and 3, 12, and 24 months after baseline
Changes in self-reported sick leave
Participants will be asked to report the number of days they have been on sick leave.
Measured: Baseline, 1 year after baseline, and 2 years after baseline
Treatment side effects
Participants will complete a questionnaire that includes 10 items that measure the perceived severity of potential side effects of sleep restriction therapy on a Likert scale. The scores range from 1 to 4. Higher scores indicate more severe side effects. The questionnaire also includes a question asking about the time for side effects (e.g., in the beginning of treatment, mid-treatment etc.).
Measured: 3 months after baseline
Treatment adherence
Participants will complete a questionnaire that includes nine items that measure self-rated adherence to sleep restriction therapy on a Likert scale. Higher scores indicate better adherence. The score on each item range from 1 to 4.
Measured: 3 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2021
- Study start1 Feb 2022
- Primary completion30 Aug 2027 (estimated)
- Study completion30 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by Region StockholmThe sponsor's other registered studies.
- 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
- Model description
- A multi-center randomized controlled trial in primary health care with two parallel study arms: (1) sleep restriction group therapy (experimental condition) and (2) sleep hygiene (control condition).
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Stockholm
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Christina Sandlund, PhD, Principal investigator, Region Stockholm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04975776
- Sponsor's protocol ID
- FoUI-936149
- Status last verified
- Dec 2025
- First submitted
- 15 Jul 2021
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Maurer LF, Schneider J, Miller CB, Espie CA, Kyle SD. The clinical effects of sleep restriction therapy for insomnia: A meta-analysis of randomised controlled trials. Sleep Med Rev. 2021 Aug;58:101493. doi: 10.1016/j.smrv.2021.101493. Epub 2021 Apr 21.
PubMed 33984745Kyle SD, Morgan K, Spiegelhalder K, Espie CA. No pain, no gain: an exploratory within-subjects mixed-methods evaluation of the patient experience of sleep restriction therapy (SRT) for insomnia. Sleep Med. 2011 Sep;12(8):735-47. doi: 10.1016/j.sleep.2011.03.016. Epub 2011 Sep 9.
PubMed 21907616Sandlund C, Hetta J, Nilsson GH, Ekstedt M, Westman J. Improving insomnia in primary care patients: A randomized controlled trial of nurse-led group treatment. Int J Nurs Stud. 2017 Jul;72:30-41. doi: 10.1016/j.ijnurstu.2017.03.007. Epub 2017 Apr 14.
PubMed 28445790Sandlund C, Kane K, Ekstedt M, Westman J. Patients' experiences of motivation, change, and challenges in group treatment for insomnia in primary care: a focus group study. BMC Fam Pract. 2018 Jul 9;19(1):111. doi: 10.1186/s12875-018-0798-2.
PubMed 29986651Riemann D, Baglioni C, Bassetti C, Bjorvatn B, Dolenc Groselj L, Ellis JG, Espie CA, Garcia-Borreguero D, Gjerstad M, Goncalves M, Hertenstein E, Jansson-Frojmark M, Jennum PJ, Leger D, Nissen C, Parrino L, Paunio T, Pevernagie D, Verbraecken J, Weess HG, Wichniak A, Zavalko I, Arnardottir ES, Deleanu OC, Strazisar B, Zoetmulder M, Spiegelhalder K. European guideline for the diagnosis and treatment of insomnia. J Sleep Res. 2017 Dec;26(6):675-700. doi: 10.1111/jsr.12594. Epub 2017 Sep 5.
PubMed 28875581
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Restriction Therapy for Insomnia Delivered as Group Therapy in Primary Health Care: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04975776
- Acronym / sponsor ID
- FoUI-936149
- Conditions
- Insomnia
- Keywords
- Disorders of Initiating and Maintaining Sleep, DIMS, Early Awakening, Awakening, Early, Nonorganic Insomnia, Insomnia, Nonorganic, Primary Insomnia, Insomnia, Primary
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Region StockholmOther government
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 30 Aug 2027 (estimated)
- Study completion
- 30 Aug 2027 (estimated)
- First posted
- 23 Jul 2021 (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.
The recommended treatment for insomnia, cognitive behavioral therapy for insomnia (CBT-I), is effective. However, its long, multi-component nature makes it challenging to implement in ordinary primary care, where most people are treated. An important component of CBT-I is sleep restriction therapy, which may be comparatively easy to carry out in routine primary care. This project tests whether a brief nurse-led group intervention in primary care based on sleep restriction therapy for insomnia reduces insomnia severity and is cost-effective.
Detailed description
Background: Insomnia is typically treated in primary health care. The most common treatment is hypnotic drugs, despite their limited and short-term effects, the risk for adverse side effects and dependence, and the fact that CBT-I is the recommended first-line treatment. Reasons may include lack of knowledge about insomnia, a culture of prescribing hypnotics, lack of time during consultations, and a shortage of CBT-I providers. Sleep restriction therapy is one of the core components of CBT-I. It is a behavioral technique that may be feasible to deliver in routine care with existing resources and time constraints.
Objectives: This randomized controlled trial aims to investigate whether brief, behavioral group therapy in primary care based on sleep restriction therapy reduces insomnia severity and is cost-effective. A process evaluation will explore barriers and facilitators for participation and delivery.
Methods: Health care professionals from participating primary health care centers will complete a 1.5-day digital course on assessing patients for insomnia and delivering the intervention. Patients who seek primary health care and meet the study criteria will be randomized to sleep restriction therapy or to receive written sleep hygiene information. Both groups will be free to seek and receive standard care for insomnia. Sociodemographic and clinical characteristics will be collected prior to baseline. Study outcomes include insomnia severity, sleep, daytime symptoms, quality of life, use of hypnotics, sick leave, and work ability. Outcomes will be assessed over a 24-month period. The cost-effectiveness analysis will include the number of insomnia-free days at the 12-month follow-up and quality-adjusted life years. Patient characteristics will be analyzed in relation to adherence, and response. Qualitative explorations of patients and nurses' experiences will be conducted alongside the trial (approximately 15 patients and 15 nurses).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- A multi-center randomized controlled trial in primary health care with two parallel study arms: (1) sleep restriction group therapy (experimental condition) and (2) sleep hygiene (control condition).
| Arm | Type | Receives |
|---|---|---|
| Sleep restriction therapy | Experimental | Behavioral: Sleep restriction therapyFour group sessions delivered at the participants' primary health care centers once a week for 3 weeks and again after a 4-week pause. The first session will last for 2 hours and the other sessions for 1 hour. |
| Sleep hygiene | Active comparator | Behavioral: Sleep hygieneParticipants in the active comparator group will receive a brochure with sleep hygiene advice from the primary health care center at baseline. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Fulfills the DSM-5 diagnostic criteria for insomnia disorder: a) Difficulty initiating sleep, difficulty maintaining sleep, and early morning awakenings despite adequate opportunity for sleep (e.g., adequate time and circumstances for sleep and a safe, quiet, and dark bedroom). b) The sleep difficulties cause significant distress or impairment in social, occupational, educational, academic, behavioral, or other important areas of functioning. c) The sleep difficulties occur at least 3 nights per week and have been present for at least 3 months. d) The symptoms are not better explained by and do not occur exclusively during the course of another sleep-wake disorder. e) The symptoms cannot be attributed to the effects of a substance (e.g., drug abuse and medication). f) Coexisting mental disorders and medical conditions do not adequately explain the predominant complaint of insomnia.
Key exclusion criteria (9 listed)
- Severe psychiatric illness (e.g., severe depression, schizophrenia, bipolar disorder)
- Suicidal ideation
- Untreated sleep disorder other than insomnia (e.g., sleep apnea, and restless legs syndrome)
- Epilepsy
- Cognitive disorder
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 |
|---|---|---|
| Sleep restriction therapyThe intervention includes psychoeducation and sleep restriction therapy, sleep restriction instructions, problem-solving, and support for participants in adjusting sleep restriction instructions to their individual needs and life circumstances. At the final session, participants create an individual plan for maintaining new sleep habits and coping with insomnia relapse. During the intervention, participants are free to seek and receive standard care for insomnia. | Behavioural | Sleep restriction therapy |
| Sleep hygieneThe control condition will include written, general information about sleep and lifestyle and environmental factors that could improve or disturb sleep. The participants will be free to seek and receive standard care for insomnia. | Behavioural | Sleep hygiene |
Primary outcome
Change in Insomnia Severity Index (ISI) score
Time frame: Baseline and 3, 6, 12, and 24 months after baseline
The ISI is a 7-item scale that asesses the severity of sleep disturbance, how much sleep disturbance interferes with daily life and functioning, the noticeability of these impairments to others, worry and distress resulting from sleep disturbance, and general sleep satisfaction/dissatisfaction. Responses are provided on a Likert-scale (0-4). The total score ranges from 0 to 28, and higher scores indicate more severe problems.
16 secondary outcomes
Change in sleep efficiency derived from sleep diary
Time frame: Baseline and 3, 12, and 24 months after baseline
Change in sleep onset latency derived from sleep diary
Time frame: Baseline and 3, 12, and 24 months after baseline
Change in time awake after sleep onset derived from sleep diary
Time frame: Baseline and 3, 12, and 24 months after baseline
Change in number of nocturnal awakenings derived from sleep diary
Time frame: Baseline and 3, 12, and 24 months after baseline
Change in sleep quality derived from sleep diary
Time frame: Baseline and 3, 12, and 24 months after baseline
Change in Fatigue Severity Scale (FSS) score
Time frame: Baseline and 3, 12, and 24 months after baseline
Change in the Montgomery-Asberg Depression Rating Scale - self-rating version (MADRS-S) score
Time frame: Baseline and 3, 12, and 24 months after baseline
Changes in the EQ-5D score
Time frame: Baseline and 3, 12, and 24 months after baseline
Changes in the Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS) score
Time frame: Baseline and 3, 12, and 24 months after baseline
Changes in Work Ability Index (WAI) score
Time frame: Baseline, 1 year after baseline, and 2 years after baseline
Changes in Short Form Health Survey-12 (SF- 12) score
Time frame: Baseline and 3, 12, and 24 months after baseline
Change in Work and Social Adjustment Scale (WSAS) scores
Time frame: Baseline and 3, 12, and 24 months after baseline
Changes in self-reported hypnotic drug use
Time frame: Baseline and 3, 12, and 24 months after baseline
Changes in self-reported sick leave
Time frame: Baseline, 1 year after baseline, and 2 years after baseline
Treatment side effects
Time frame: 3 months after baseline
Treatment adherence
Time frame: 3 months after baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Background: PubMed 33984745Maurer LF, Schneider J, Miller CB, Espie CA, Kyle SD. The clinical effects of sleep restriction therapy for insomnia: A meta-analysis of randomised controlled trials. Sleep Med Rev. 2021 Aug;58:101493. doi: 10.1016/j.smrv.2021.101493. Epub 2021 Apr 21.
- Background: PubMed 21907616Kyle SD, Morgan K, Spiegelhalder K, Espie CA. No pain, no gain: an exploratory within-subjects mixed-methods evaluation of the patient experience of sleep restriction therapy (SRT) for insomnia. Sleep Med. 2011 Sep;12(8):735-47. doi: 10.1016/j.sleep.2011.03.016. Epub 2011 Sep 9.
- Background: PubMed 28445790Sandlund C, Hetta J, Nilsson GH, Ekstedt M, Westman J. Improving insomnia in primary care patients: A randomized controlled trial of nurse-led group treatment. Int J Nurs Stud. 2017 Jul;72:30-41. doi: 10.1016/j.ijnurstu.2017.03.007. Epub 2017 Apr 14.
- Background: PubMed 29986651Sandlund C, Kane K, Ekstedt M, Westman J. Patients' experiences of motivation, change, and challenges in group treatment for insomnia in primary care: a focus group study. BMC Fam Pract. 2018 Jul 9;19(1):111. doi: 10.1186/s12875-018-0798-2.
- Background: PubMed 28875581Riemann D, Baglioni C, Bassetti C, Bjorvatn B, Dolenc Groselj L, Ellis JG, Espie CA, Garcia-Borreguero D, Gjerstad M, Goncalves M, Hertenstein E, Jansson-Frojmark M, Jennum PJ, Leger D, Nissen C, Parrino L, Paunio T, Pevernagie D, Verbraecken J, Weess HG, Wichniak A, Zavalko I, Arnardottir ES, Deleanu OC, Strazisar B, Zoetmulder M, Spiegelhalder K. European guideline for the diagnosis and treatment of insomnia. J Sleep Res. 2017 Dec;26(6):675-700. doi: 10.1111/jsr.12594. Epub 2017 Sep 5.
- Academic Primary Health Care Centre, Region StockholmLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Christina Sandlund, PhD principal investigator
Region Stockholm
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep restriction therapy and Sleep hygiene in people with Insomnia, run by Region Stockholm at 1 site in Sweden.
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 1 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 23 Dec 2025. 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 Sweden. 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in Insomnia Severity Index (ISI) score (time frame: Baseline and 3, 6, 12, and 24 months after baseline). 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 NCT04975776, which also lists 5 linked publications.
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 23 Dec 2025.