Sleep Disorder; Insomnia TypeSIPNCT04463498
Sleep in Psychiatric Care (SIP): A Transdiagnostic Group-based Sleep-school as Treatment for Comorbid Insomnia
A study testing Group-based cognitive behavioral therapy for insomnia, Group-based cognitive behavioral therapy for insomnia and additive bb-glasses and 8-week wait list for sleep-school in people with Sleep Disorder; Insomnia Type and Psychiatric Disorders, run by Haukeland University Hospital at 1 site in Norway.
Trial summary
Sleep disorders commonly co-occur with psychiatric disorders. Sleep disorders are often treated with medication or not at all in psychiatric care, although there exist a plethora of documentation of the effectiveness of sleep interventions. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sleep Disorder; Insomnia Type, Psychiatric Disorders
- What is being tested?
- Group-based cognitive behavioral therapy for insomnia, Group-based cognitive behavioral therapy for insomnia and additive bb-glasses and 8-week wait list for sleep-school
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteNorway
- Study dates
- 17 Dec 2021to 31 Dec 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients referred to the sleep-school at Bjørgvin DPS psychiatric hospital
- Patients fulfilling the Diagnostic Manual for Mental Disorders (DSM-V) criteria for insomnia comorbid to moderate to severe psychiatric illness (confirmed F-diagnosis based on the International Statistical Classification of Diseases and Related Health Problems (ICD-11) diagnostic system that are used in Norway in addition to insomnia and/or scores of ≥19 on BDI and/or scores of ≥16 on BAI at the time of referral to the sleep school)
Who cannot join
- Nightwork
- Patients that do not fulfil the DSM-V criteria for insomnia comorbid to moderate to severe psychiatric illness (confirmed F-diagnosis based on the ICD-10 diagnostic system that are used in Norway in addition to insomnia and/or scores of ≥19 on BDI and/or scores of ≥16 on BAI at the time of referral to the sleep school)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
Haukeland University Hospital
Bergen, 5113
Ane Wilhelmsen-Langeland, PhD, +47 92843253, ane.wilhelmsen-langeland@helse-bergen.no
Berge Osnes, PhD, +47 92445081, berge.osnes@uib.no
About this study
Official title: Sleep in Psychiatric Care: A Transdiagnostic Group-based Sleep-school as Treatment for Comorbid Insomnia
Sleep disorders commonly co-occur with psychiatric disorders. Sleep disorders are often treated with medication or not at all in psychiatric care, although there exist a plethora of documentation of the effectiveness of sleep interventions. There is also an increase in studies showing effectiveness of sleep-interventions when the sleep disorder co-occurs with psychiatric illness. The most common and best documented treatment for insomnia is cognitive behavioral therapy for insomnia (CBTi). There is a great gap in the knowledge on how sleep disorders can be treated effectively in psychiatric care. In this project the investigators therefore seek to investigate the effect of non-pharmacological, group-based treatment in a randomized controlled trial (RCT) where sleep and psychiatric symptoms are the primary outcome measures. CBTi comprise of sleep education, sleep restriction, stimulus control and cognitive restructuring of dysfunctional thoughts about sleep.
Read the detailed description
The recommended treatment for insomnia is CBTi. Recent research has proven that dark therapy, or blocking light in wavelengths <530 nm by the use of for example orange blue-blocking glasses (bb-glasses), has shown the ability to maintain melatonin production comparable to darkness and to have an additive effect in the treatment of insomnia. The investigators therefore also want to test bb-glasses as an additive treatment to CBTi for insomnia.
The sleep-school at Bjørgvin District Psychiatric Hospital (DPS) is an already established treatment since 2017. The insomnia-group gets together every other Monday from noon until 2 pm. The group is open, which means that participants start at different dates and meet people in the group that might be at the end of their CBTi treatment. Participants are patients at the general psychiatric outpatient clinic at Bjørgvin DPS. Participant have been referred to the sleep-team by their psychologist or doctor. In this RCT the investigators will carry on the same structure for the group for participants that are recruited to the RCT.
All participants have an individual consultation before joining the group where the focus is on eligibility to participate in the group-based treatment, diagnostic evaluation, receive a standardized education on sleep-regulation and sleep hygiene advice and receive a date to start the group-based CBTi treatment. In a randomized manner, they will be allocated to the sleep-school group and start the treatment on the next possible date or to a 8 week wait-list and receive a date the treatment starts. All eligible participants will be informed that there may be a waitlist and receive a start-date without being informed that thay are in a waitlist group or not a waitlist group. All participants will be treated as usual (TAU) for their psychiatric problems parallel to either sleep-school or waitlist. Participants that start sleep-school as soon as possible, are also allocated to a) ordinary group-based CBTi 8 weeks or b) group-based CBTi 8 weeks and bb-glasses. All participant will be followed up after 12 months.
- Being tested
- Group-based cognitive behavioral therapy for insomnia, Group-based cognitive behavioral therapy for insomnia and additive bb-glasses, 8-week wait list for sleep-school
- Keywords
- sleep disorders, insomnia, psychiatric disorders, bb-glasses, group-based cognitive behavioural therapy for insomnia
- Medical subject headings
- Sleep Wake Disorders, Mental Disorders, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group-based cognitive behavioral therapy for insomniaBehavioural
Also called Group - CBTi
Sleep education, sleep restriction, stimulus control, cognitive restructuring, relaxation techniques
Group-based cognitive behavioral therapy for insomnia and additive bb-glassesBehavioural
Also called Group - CBTi & bb-glasses
Sleep education, sleep restriction, stimulus control, cognitive restructuring, relaxation techniques, bb-glasses worn from 3 hrs before bedtime.
8-week wait list for sleep-schoolOther
Also called Treatment as usual
Treatment as usual in a psychiatric outpatient clinic
| Study group | Role | What they receive |
|---|---|---|
| n=15, Sleep-school 8 weeks | Experimental | Patients receive treatment as usual in the psychiatric clinic combined with participation in the sleep school. They have already been given education on sleep regulation and sleep hygiene advice in the first meeting with the sleep-school facilitator. Receives: Behavioral: Group-based cognitive behavioral therapy for insomnia |
| n=15, Sleep-school 8 weeks and additive bb-glasses | Experimental | Patients receive treatment as usual in the psychiatric clinic combined with participation in the sleep school and additive treatment with bb-glasses. They have already been given education on sleep regulation and sleep hygiene advice in the first meeting with the sleep-school facilitator. Receives: Behavioral: Group-based cognitive behavioral therapy for insomnia; Behavioral: Group-based cognitive behavioral therapy for insomnia and additive bb-glasses |
| n=30 8-week wait list for sleep-school | Active comparator | Patients receive treatment as usual in the psychiatric clinic while they wait for participation in the sleep school. They have already been given education on sleep regulation and sleep hygiene advice in the first meeting with the sleep-school facilitator. Receives: Other: 8-week wait list for sleep-school |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia symptoms
Measured by the questionnaires Insomnia severity Index (ISI) and Bergen Insomnia Scale (BIS). From sleep diaries; sleep onset latency (SOL), wake after sleep onset (WASO) and sleep efficiency (SE).
Measured: baseline, bi-weekly and post intervention after 8 weeks, follow-up after 12 months
Secondary outcomes (19)
Changes in insomnia diagnosis
Measured by the Bergen Bergen Insomnia Scale (BIS). The BIS measure subjective symptoms of insomnia during the previous week and give a total score (minimum 0, maximum 42; the higher the score, the worse severity of insomnia) and a clinical incidence of insomnia diagnosis-score (yes/no)
Measured: baseline and post intervention after 8 weeks, follow-up after 12 months
Changes in insomnia severity
Measured by the Insomnia Severity Index (ISI). The ISI is a 7-item scale assessing the perceived severity of insomnia symptoms (initial, middle, terminal), the degree of satisfaction with sleep, interference with daytime functioning, noticeability of impairment, and concern caused by the sleep problems. The scale is Likert-type with 5 anchor points ranging from 0 to 4. The scale ranges from 0 to 28 and the higher the score, the more severe insomnia. The usual time frame for responding is the last 2 weeks.
Measured: baseline and post intervention after 8 weeks, follow-up after 12 months
Changes in Time in bed (TIB)
Measured by sleep diary; time from bed-time to rise time
Measured: baseline, bi-weekly assesment and post intervention after 8 weeks, follow-up after 12 months
Changes in objective early morning awakening (EMA)
Measured by Actiwatch (AW) Spectrum PLUSS. The activity recorder is worn on the wrist for 7 consecutive days. The data is downloaded to a computer program that gives the data; a number of average minutes early morning awakening.
Measured: baseline and post intervention after 8 weeks, follow-up after 12 months
Changes in objective wake after sleep onset (WASO)
Measured by Actiwatch (AW) Spectrum PLUSS. The activity recorder is worn on the wrist for 7 consecutive days. The data is downloaded to a computer program that gives the data; a number of average minutes awake after sleep onset.
Measured: baseline and post intervention after 8 weeks, follow-up after 12 months
Changes in Early morning awakening (EMA)
Measured by sleep diary; minutes awake before rise time
Measured: baseline, bi-weekly assesment and post intervention after 8 weeks, follow-up after 12 months
Changes in objective time in bed (TIB)
Measured by Actiwatch (AW) Spectrum PLUSS. The activity recorder is worn on the wrist for 7 consecutive days. The data is downloaded to a computer program that gives the data; a number in minutes of average time in bed.
Measured: baseline and post intervention after 8 weeks, follow-up after 12 months
Changes in objective sleep efficiency (SE)
Measured by Actiwatch (AW) Spectrum PLUSS. The activity recorder is worn on the wrist for 7 consecutive days. The data is downloaded to a computer program that gives the data; a number from 0-100% that gives average sleep efficiency.
Measured: baseline and post intervention after 8 weeks, follow-up after 12 months
Changes in objective total sleep length/time asleep (TST),
Measured by Actiwatch (AW) Spectrum PLUSS. The activity recorder is worn on the wrist for 7 consecutive days. The data is downloaded to a computer program that gives the data; a number in minutes of average total sleep time.
Measured: baseline and post intervention after 8 weeks, follow-up after 12 months
Changes in Total sleep length/time asleep (TST)
Measured by sleep diary: Time in bed minus time awake
Measured: baseline, bi-weekly assesment and post intervention after 8 weeks, follow-up after 12 months
Changes in Sleep quality (SQ)
Measured by sleep diary; subjective assesment of sleep quality on a scale from 1=very light to 5=very deep
Measured: baseline, bi-weekly assesment and post intervention after 8 weeks, follow-up after 12 months
Changes in Daytime function (DF)
Measured by sleep diary; subjective assesment of daytime function on a scale from 1=very good to 5=very poor
Measured: baseline, bi-weekly assesment and post intervention after 8 weeks, follow-up after 12 months
Changes in objective sleep onset latency (SOL)
Measured by Actiwatch (AW) Spectrum PLUSS. The activity recorder is worn on the wrist for 7 consecutive days. The data is downloaded to a computer program that gives the data; a number of minutes of average sleep onset latency.
Measured: baseline and post intervention after 8 weeks, follow-up after 12 months
Changes in beliefs and attitudes about sleep
Measured by Dysfunctional Beliefs and Attitudes about Sleep (DBAS-16). The DBAS-16 measures the degree of dysfunctional beliefs about sleep with 16 items. It has 4 subscales (1) sleep-related worry and helplessness; 2) beliefs about sleep medications; 3) expectations about sleep need; and 4) beliefs about the consequences/effects of insomnia and 1 total scale score. The higher the score, the more dysfunctional beliefs about sleep.
Measured: baseline and post intervention after 8 weeks, follow-up after 12 months
Changes in depression
Measured by Becks Depression Inventory -II (BDI-II). The higher the score, the more symptoms of depression
Measured: baseline and post intervention after 8 weeks, follow-up after 12 months
Changes in anxiety
Measured by Becks Anxiety Inventory (BAI). The higher the score, the more symptoms of anxiety
Measured: baseline and post intervention after 8 weeks, follow-up after 12 months
Changes in fatigue
Measured by Chalder fatigue Scale (CFQ). The higher the score, the more fatigued
Measured: baseline and post intervention after 8 weeks, and at follow-up after 12 months
Work status
Status of employment/unemployment, percentage disability benefits received. Measured by Work and social adjustment scale (WSAS) and self-report.
Measured: baseline and post intervention after 8 weeks, and at follow-up after 12 months
Well-being
Measured by World Health Organization well-being scale (WHO-5). The higher the score, the higher well-being.
Measured: baseline and post intervention after 8 weeks, and at follow-up after 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2020
- Study start17 Dec 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
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 Sleep Disorder; Insomnia TypeStudies of the same condition, open and under way.
- More trials run by Haukeland University HospitalThe 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
- Randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bergen
- Responsible party
- Sponsor
- Investigators
- Ane Wilhelmsen-Langeland, PhD, Principal investigator, Haukeland University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04463498
- Sponsor's protocol ID
- 66304
- Acronym
- SIP
- Status last verified
- Jun 2024
- First submitted
- 6 Apr 2020
- Last updated
- 18 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators plan to share the following individual participant data (IPD); Study protocol and Informed Consent Form (ICF) IPD Sharing Time Frame Definition: A description of when the IPD and any additional supporting information will become available and for how long, including the start and end dates or period of availability. This may be provided as an absolute date (for example, starting in January 2025) or as a date relative to the time when summary data are published or otherwise made available (for example, starting 6 months after publication). Limit: 1000 characters. IPD Sharing Access Criteria Definition: Describe by what access criteria IPD and any additional supporting information will be shared, including with whom, for what types of analyses, and by what mechanism. Information about who will review requests and criteria for reviewing requests may also be provided.
Publications
Wilhelmsen-Langeland A, Saxvig IW, Gradisar M, Vagenes VA, Pallesen S, Sorensen L, Fasmer OB, Koenig J, Bjorvatn B, Osnes B. Group cognitive behavioural therapy for insomnia compared with treatment as usual for sleep problems in psychiatric care (the SIP trials): a protocol for a pragmatic, randomised controlled trial. BMJ Open. 2025 Apr 17;15(4):e090997. doi: 10.1136/bmjopen-2024-090997.
PubMed 40250874
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep in Psychiatric Care: A Transdiagnostic Group-based Sleep-school as Treatment for Comorbid Insomnia
- ClinicalTrials.gov ID
- NCT04463498
- Acronym / sponsor ID
- SIP / 66304
- Keywords
- sleep disorders, insomnia, psychiatric disorders, bb-glasses, group-based cognitive behavioural therapy for insomnia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Collaborators
- University of Bergen
- Study start
- 17 Dec 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 9 Jul 2020 (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.
Sleep disorders commonly co-occur with psychiatric disorders. Sleep disorders are often treated with medication or not at all in psychiatric care, although there exist a plethora of documentation of the effectiveness of sleep interventions. There is also an increase in studies showing effectiveness of sleep-interventions when the sleep disorder co-occurs with psychiatric illness. The most common and best documented treatment for insomnia is cognitive behavioral therapy for insomnia (CBTi). There is a great gap in the knowledge on how sleep disorders can be treated effectively in psychiatric care. In this project the investigators therefore seek to investigate the effect of non-pharmacological, group-based treatment in a randomized controlled trial (RCT) where sleep and psychiatric symptoms are the primary outcome measures. CBTi comprise of sleep education, sleep restriction, stimulus control and cognitive restructuring of dysfunctional thoughts about sleep.
Detailed description
The recommended treatment for insomnia is CBTi. Recent research has proven that dark therapy, or blocking light in wavelengths <530 nm by the use of for example orange blue-blocking glasses (bb-glasses), has shown the ability to maintain melatonin production comparable to darkness and to have an additive effect in the treatment of insomnia. The investigators therefore also want to test bb-glasses as an additive treatment to CBTi for insomnia.
The sleep-school at Bjørgvin District Psychiatric Hospital (DPS) is an already established treatment since 2017. The insomnia-group gets together every other Monday from noon until 2 pm. The group is open, which means that participants start at different dates and meet people in the group that might be at the end of their CBTi treatment. Participants are patients at the general psychiatric outpatient clinic at Bjørgvin DPS. Participant have been referred to the sleep-team by their psychologist or doctor. In this RCT the investigators will carry on the same structure for the group for participants that are recruited to the RCT.
All participants have an individual consultation before joining the group where the focus is on eligibility to participate in the group-based treatment, diagnostic evaluation, receive a standardized education on sleep-regulation and sleep hygiene advice and receive a date to start the group-based CBTi treatment. In a randomized manner, they will be allocated to the sleep-school group and start the treatment on the next possible date or to a 8 week wait-list and receive a date the treatment starts. All eligible participants will be informed that there may be a waitlist and receive a start-date without being informed that thay are in a waitlist group or not a waitlist group. All participants will be treated as usual (TAU) for their psychiatric problems parallel to either sleep-school or waitlist. Participants that start sleep-school as soon as possible, are also allocated to a) ordinary group-based CBTi 8 weeks or b) group-based CBTi 8 weeks and bb-glasses. All participant will be followed up after 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| n=15, Sleep-school 8 weeks | Experimental | Behavioral: Group-based cognitive behavioral therapy for insomniaPatients receive treatment as usual in the psychiatric clinic combined with participation in the sleep school. They have already been given education on sleep regulation and sleep hygiene advice in the first meeting with the sleep-school facilitator. |
| n=15, Sleep-school 8 weeks and additive bb-glasses | Experimental | Behavioral: Group-based cognitive behavioral therapy for insomnia, Behavioral: Group-based cognitive behavioral therapy for insomnia and additive bb-glassesPatients receive treatment as usual in the psychiatric clinic combined with participation in the sleep school and additive treatment with bb-glasses. They have already been given education on sleep regulation and sleep hygiene advice in the first meeting with the sleep-school facilitator. |
| n=30 8-week wait list for sleep-school | Active comparator | Other: 8-week wait list for sleep-schoolPatients receive treatment as usual in the psychiatric clinic while they wait for participation in the sleep school. They have already been given education on sleep regulation and sleep hygiene advice in the first meeting with the sleep-school facilitator. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients referred to the sleep-school at Bjørgvin DPS psychiatric hospital
- Patients fulfilling the Diagnostic Manual for Mental Disorders (DSM-V) criteria for insomnia comorbid to moderate to severe psychiatric illness (confirmed F-diagnosis based on the International Statistical Classification of Diseases and Related Health Problems (ICD-11) diagnostic system that are used in Norway in addition to insomnia and/or scores of ≥19 on BDI and/or scores of ≥16 on BAI at the time of referral to the sleep school)
Key exclusion criteria (2 listed)
- Nightwork
- Patients that do not fulfil the DSM-V criteria for insomnia comorbid to moderate to severe psychiatric illness (confirmed F-diagnosis based on the ICD-10 diagnostic system that are used in Norway in addition to insomnia and/or scores of ≥19 on BDI and/or scores of ≥16 on BAI at the time of referral to the sleep school)
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 |
|---|---|---|
| Group-based cognitive behavioral therapy for insomniaAlso: Group - CBTiSleep education, sleep restriction, stimulus control, cognitive restructuring, relaxation techniques | Behavioural | n=15, Sleep-school 8 weeks, n=15, Sleep-school 8 weeks and additive bb-glasses |
| Group-based cognitive behavioral therapy for insomnia and additive bb-glassesAlso: Group - CBTi & bb-glassesSleep education, sleep restriction, stimulus control, cognitive restructuring, relaxation techniques, bb-glasses worn from 3 hrs before bedtime. | Behavioural | n=15, Sleep-school 8 weeks and additive bb-glasses |
| 8-week wait list for sleep-schoolAlso: Treatment as usualTreatment as usual in a psychiatric outpatient clinic | Other | n=30 8-week wait list for sleep-school |
Primary outcome
Insomnia symptoms
Time frame: baseline, bi-weekly and post intervention after 8 weeks, follow-up after 12 months
Measured by the questionnaires Insomnia severity Index (ISI) and Bergen Insomnia Scale (BIS). From sleep diaries; sleep onset latency (SOL), wake after sleep onset (WASO) and sleep efficiency (SE).
19 secondary outcomes
Changes in insomnia diagnosis
Time frame: baseline and post intervention after 8 weeks, follow-up after 12 months
Changes in insomnia severity
Time frame: baseline and post intervention after 8 weeks, follow-up after 12 months
Changes in Time in bed (TIB)
Time frame: baseline, bi-weekly assesment and post intervention after 8 weeks, follow-up after 12 months
Changes in objective early morning awakening (EMA)
Time frame: baseline and post intervention after 8 weeks, follow-up after 12 months
Changes in objective wake after sleep onset (WASO)
Time frame: baseline and post intervention after 8 weeks, follow-up after 12 months
Changes in Early morning awakening (EMA)
Time frame: baseline, bi-weekly assesment and post intervention after 8 weeks, follow-up after 12 months
Changes in objective time in bed (TIB)
Time frame: baseline and post intervention after 8 weeks, follow-up after 12 months
Changes in objective sleep efficiency (SE)
Time frame: baseline and post intervention after 8 weeks, follow-up after 12 months
Changes in objective total sleep length/time asleep (TST),
Time frame: baseline and post intervention after 8 weeks, follow-up after 12 months
Changes in Total sleep length/time asleep (TST)
Time frame: baseline, bi-weekly assesment and post intervention after 8 weeks, follow-up after 12 months
Changes in Sleep quality (SQ)
Time frame: baseline, bi-weekly assesment and post intervention after 8 weeks, follow-up after 12 months
Changes in Daytime function (DF)
Time frame: baseline, bi-weekly assesment and post intervention after 8 weeks, follow-up after 12 months
Changes in objective sleep onset latency (SOL)
Time frame: baseline and post intervention after 8 weeks, follow-up after 12 months
Changes in beliefs and attitudes about sleep
Time frame: baseline and post intervention after 8 weeks, follow-up after 12 months
Changes in depression
Time frame: baseline and post intervention after 8 weeks, follow-up after 12 months
Changes in anxiety
Time frame: baseline and post intervention after 8 weeks, follow-up after 12 months
Changes in fatigue
Time frame: baseline and post intervention after 8 weeks, and at follow-up after 12 months
Work status
Time frame: baseline and post intervention after 8 weeks, and at follow-up after 12 months
Well-being
Time frame: baseline and post intervention after 8 weeks, and at follow-up after 12 months
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 18 Jun 2024.
- Derived from this study: PubMed 40250874Wilhelmsen-Langeland A, Saxvig IW, Gradisar M, Vagenes VA, Pallesen S, Sorensen L, Fasmer OB, Koenig J, Bjorvatn B, Osnes B. Group cognitive behavioural therapy for insomnia compared with treatment as usual for sleep problems in psychiatric care (the SIP trials): a protocol for a pragmatic, randomised controlled trial. BMJ Open. 2025 Apr 17;15(4):e090997. doi: 10.1136/bmjopen-2024-090997.
- Individual participant dataSharing planned: Yes. The investigators plan to share the following individual participant data (IPD); Study protocol and Informed Consent Form (ICF) IPD Sharing Time Frame Definition: A description of when the IPD and any additional supporting information will become available and for how long, including the start and end dates or period of availability. This may be provided as an absolute date (for example, starting in January 2025) or as a date relative to the time when summary data are published or otherwise made available (for example, starting 6 months after publication). Limit: 1000 characters. IPD Sharing Access Criteria Definition: Describe by what access criteria IPD and any additional supporting information will be shared, including with whom, for what types of analyses, and by what mechanism. Information about who will review requests and criteria for reviewing requests may also be provided.
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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.
Ane Wilhelmsen-Langeland, PhD principal investigator
Haukeland University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group-based cognitive behavioral therapy for insomnia, Group-based cognitive behavioral therapy for insomnia and additive bb-glasses and 8-week wait list for sleep-school in people with Sleep Disorder; Insomnia Type and Psychiatric Disorders, run by Haukeland University Hospital at 1 site in Norway.
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 2 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 18 Jun 2024. 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 Norway. 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?
Contact Ane Wilhelmsen-Langeland, PhD (+47 55957000, ane.wilhelmsen-langeland@helse-bergen.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia symptoms (time frame: baseline, bi-weekly and post intervention after 8 weeks, follow-up after 12 months). 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 NCT04463498, 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 18 Jun 2024.