Sleep ProblemBSIP-DAPNCT04136054
Better Sleep in Psychiatric Care - Depression, Anxiety and PTSD
A study testing Adjusted group CBT-i for Depression, Anxiety and PTSD in people with Sleep Problem and Anxiety Disorders, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
Cognitive Behavioral Therapy (CBT) is treatment of choice for insomnia. Many patients in psychiatric care have sleep problems including insomnia, but are rarely given the choice to participate in CBT to improve their sleep. Patients with PTSD, Anxiety disorders and Depression display high levels of sleep difficulties. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Problem, Anxiety Disorders, Affective Disorder
- What is being tested?
- Adjusted group CBT-i for Depression, Anxiety and PTSD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- 1 siteSweden
- Study dates
- 25 Sep 2019to 22 Sep 2025
- 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
- Being a patient at the clinics involved in the project
- Experiencing sleep problems (subjective report) above 10 points on the ISI
- Being able to participate in a psychological intervention in group format in Swedish
Who cannot join
- Night shift work
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Program for Affective disorders, Anxiety and Trauma, Stockholm Southwest Psychiatry
Stockholm, 141 86
About this study
Official title: Better Sleep in Psychiatric Care - Depression, Anxiety and PTSD. A Randomized Naturalistic Study of a Psychological Group Treatment for Sleep Problems in Psychiatric Patients With Depression, Anxiety and PTSD.
Cognitive Behavioral Therapy (CBT) is treatment of choice for insomnia. Many patients in psychiatric care have sleep problems including insomnia, but are rarely given the choice to participate in CBT to improve their sleep. Patients with PTSD, Anxiety disorders and Depression display high levels of sleep difficulties. Sleep problems are often general, such as insomnia and sleep phase problems. In a previous pilot study, the investigators of the current study developed a CBT protocol that would target sleep problems in this mixed psychiatric population. The basis was CBT for insomnia (CBT-i), but also including techniques that would alleviate sleep phase problems (e.g. the systematic use of light and darkness), and techniques to target more general sleep related problems (e.g. difficulties waking up in the morning), that are also common in psychiatric patients. This treatment was well tolerated and gave large withing-group effects on insomnia severity in the pilot study. In a naturalistic randomized controlled trial, the investigators now evaluate the effects of this psychological treatment on sleep and anxiety and depressive symptoms in patients at the units for Anxiety and Affective disorders and Trauma, Southwest Psychiatry and Northern Stockholm Psychiatry, Stockholm County Council, Sweden.
- Conditions
- Sleep Problem, Anxiety Disorders, Affective Disorder
- Being tested
- Adjusted group CBT-i for Depression, Anxiety and PTSD, Care as usual wait-list control group
- Keywords
- Cognitive Behaviour Therapy, Psychological Intervention
- Medical subject headings
- Parasomnias, Anxiety Disorders, Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adjusted group CBT-i for Depression, Anxiety and PTSDBehavioural
Adjusted group CBT-i for Depression, Anxiety and PTSD. CBT-i includes sleep scheduling/sleep compression, stimulus control, relaxation, cognitive interventions and sleep hygiene advice. Adjustments include the relationship between sleep and the psychiatric conditions at hand and and working with motivational enhancement techniques to increase adherence to treatment.
Care as usual wait-list control groupOther
Usual care at the clinic. This entails managing pharmacological treatment for the psychiatric problems and/or sleep problems. The clinic also provides different group treatments, such as mindfulness groups and CBT groups for symptoms of worry and depression, and individual therapy.
| Study group | Role | What they receive |
|---|---|---|
| Adjusted group CBT-i for Depression, Anxiety and PTSD | Experimental | Cognitive Behavioral group intervention for sleep problems in patients with Depression, Anxiety and PTSD, based on Cognitive Behavioral Therapy for insomnia Receives: Behavioral: Adjusted group CBT-i for Depression, Anxiety and PTSD |
| Care as usual wait-list control group | Active comparator | Treatment as Usual. (After about five months, participants in this condition are offered the experimental group treatment.) Receives: Other: Care as usual wait-list control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia Severity Index (ISI)
7-item, self-rated questionnaire measuring insomnia severity. Total score 0-28, higher score indicates more severe sleep problems.
Measured: Changes from base-line to 6 weeks
Secondary outcomes (7)
Actigraphy
An actigraph is placed on the participant's arm for one week. It measures participants' arm-movements. An algorithm can be used to estimate sleep from movement data.
Measured: Changes from two weeks pre treatment (minus two weeks to base-line) to two weeks post treatment (six to eight weeks).
WHO Disability Assessment Schedule (WHODAS)
12-items self-rating questionnaire measuring disability. Total score (0-48), with higher score indicating more severe disability.
Measured: Changes from base-line to 6 weeks, 4,5 months and 13,5 months
Patient Health Questionnaire (PHQ-9)
9-items self-rating questionnaire measuring level of depression. Total score 0-27 with higher score indicating more severe depression
Measured: Changes from base-line to 6 weeks, 4,5 months and 13,5 months
Generalized Anxiety Disorder 7-item scale (GAD-7)
7-item self-rating questionnaire measuring level of anxiety. Total score 0-21 with higher score indicating more severe anxiety.
Measured: Changes from base-line to 6 weeks, 4,5 months and 13,5 months
Sleep habits and behaviors
Self-rating questionnaire regarding the use of sleep promoting behaviors. The questionnaire was constructed for the larger BSIP project and consists of two parts. The first part includes statements such as "Last week I got out of bed within 15 minutes of waking up" to be answered by number of days the last week this was true (i.e. from 0 to 7). The second part is to be answered on a 6-point Likert scale from "Not at all true" to "Entirely true", with 7 statements like "I get out of bed the same time every morning". No total score is obtained.
Measured: Changes from base-line to 6 weeks, 4,5 months and 13,5 months
Daytime Insomnia Symptoms Scale
7-item self-rating questionnaire regarding daytime symptoms commonly associated with sleep problems. Total score 0-70, with higher score indicating more severe daytime symptoms.
Measured: Changes from base-line to 6 weeks, 4,5 months and 13,5 months
Insomnia Severity Index (ISI)
7-item, self-rated questionnaire measuring insomnia severity. Total score 0-28, higher score indicates more severe sleep problems.
Measured: Changes from base-line to 4,5 months and 13,5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2019
- Study start25 Sep 2019
- Primary completion6 Feb 2024
- Study completion22 Sep 2025
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 ProblemStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm
- Responsible party
- Principal investigator, Susanna Jernelöv, Karolinska Institutet
- Investigators
- Susanna Jernelöv, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04136054
- Sponsor's protocol ID
- 2018/80-31/1.1
- Acronym
- BSIP-DAP
- Status last verified
- Aug 2026
- First submitted
- 21 Oct 2019
- Last updated
- 19 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cassel M, Blom K, Gatzacis J, Renblad P, Kaldo V, Jernelov S. Clinical feasibility of cognitive behavioural therapy for insomnia in a real-world mixed sample at a specialized psychiatric outpatient clinic. BMC Psychiatry. 2022 Sep 9;22(1):600. doi: 10.1186/s12888-022-04231-4.
PubMed 36085009
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Better Sleep in Psychiatric Care - Depression, Anxiety and PTSD. A Randomized Naturalistic Study of a Psychological Group Treatment for Sleep Problems in Psychiatric Patients With Depression, Anxiety and PTSD.
- ClinicalTrials.gov ID
- NCT04136054
- Acronym / sponsor ID
- BSIP-DAP / 2018/80-31/1.1
- Conditions
- Sleep Problem, Anxiety Disorders, Affective Disorder
- Keywords
- Cognitive Behaviour Therapy, Psychological Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Region Stockholm
- Study start
- 25 Sep 2019 (actual)
- Primary completion
- 6 Feb 2024 (actual)
- Study completion
- 22 Sep 2025 (actual)
- First posted
- 23 Oct 2019 (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.
Cognitive Behavioral Therapy (CBT) is treatment of choice for insomnia. Many patients in psychiatric care have sleep problems including insomnia, but are rarely given the choice to participate in CBT to improve their sleep. Patients with PTSD, Anxiety disorders and Depression display high levels of sleep difficulties. Sleep problems are often general, such as insomnia and sleep phase problems. In a previous pilot study, the investigators of the current study developed a CBT protocol that would target sleep problems in this mixed psychiatric population. The basis was CBT for insomnia (CBT-i), but also including techniques that would alleviate sleep phase problems (e.g. the systematic use of light and darkness), and techniques to target more general sleep related problems (e.g. difficulties waking up in the morning), that are also common in psychiatric patients. This treatment was well tolerated and gave large withing-group effects on insomnia severity in the pilot study. In a naturalistic randomized controlled trial, the investigators now evaluate the effects of this psychological treatment on sleep and anxiety and depressive symptoms in patients at the units for Anxiety and Affective disorders and Trauma, Southwest Psychiatry and Northern Stockholm Psychiatry, Stockholm County Council, Sweden.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adjusted group CBT-i for Depression, Anxiety and PTSD | Experimental | Behavioral: Adjusted group CBT-i for Depression, Anxiety and PTSDCognitive Behavioral group intervention for sleep problems in patients with Depression, Anxiety and PTSD, based on Cognitive Behavioral Therapy for insomnia |
| Care as usual wait-list control group | Active comparator | Other: Care as usual wait-list control groupTreatment as Usual. (After about five months, participants in this condition are offered the experimental group treatment.) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being a patient at the clinics involved in the project
- Experiencing sleep problems (subjective report) above 10 points on the ISI
- Being able to participate in a psychological intervention in group format in Swedish
Key exclusion criteria (1 listed)
- Night shift work
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 |
|---|---|---|
| Adjusted group CBT-i for Depression, Anxiety and PTSDAdjusted group CBT-i for Depression, Anxiety and PTSD. CBT-i includes sleep scheduling/sleep compression, stimulus control, relaxation, cognitive interventions and sleep hygiene advice. Adjustments include the relationship between sleep and the psychiatric conditions at hand and and working with motivational enhancement techniques to increase adherence to treatment. | Behavioural | Adjusted group CBT-i for Depression, Anxiety and PTSD |
| Care as usual wait-list control groupUsual care at the clinic. This entails managing pharmacological treatment for the psychiatric problems and/or sleep problems. The clinic also provides different group treatments, such as mindfulness groups and CBT groups for symptoms of worry and depression, and individual therapy. | Other | Care as usual wait-list control group |
Primary outcome
Insomnia Severity Index (ISI)
Time frame: Changes from base-line to 6 weeks
7-item, self-rated questionnaire measuring insomnia severity. Total score 0-28, higher score indicates more severe sleep problems.
7 secondary outcomes
Actigraphy
Time frame: Changes from two weeks pre treatment (minus two weeks to base-line) to two weeks post treatment (six to eight weeks).
WHO Disability Assessment Schedule (WHODAS)
Time frame: Changes from base-line to 6 weeks, 4,5 months and 13,5 months
Patient Health Questionnaire (PHQ-9)
Time frame: Changes from base-line to 6 weeks, 4,5 months and 13,5 months
Generalized Anxiety Disorder 7-item scale (GAD-7)
Time frame: Changes from base-line to 6 weeks, 4,5 months and 13,5 months
Sleep habits and behaviors
Time frame: Changes from base-line to 6 weeks, 4,5 months and 13,5 months
Daytime Insomnia Symptoms Scale
Time frame: Changes from base-line to 6 weeks, 4,5 months and 13,5 months
Insomnia Severity Index (ISI)
Time frame: Changes from base-line to 4,5 months and 13,5 months
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 19 Aug 2026.
- Background: PubMed 36085009Cassel M, Blom K, Gatzacis J, Renblad P, Kaldo V, Jernelov S. Clinical feasibility of cognitive behavioural therapy for insomnia in a real-world mixed sample at a specialized psychiatric outpatient clinic. BMC Psychiatry. 2022 Sep 9;22(1):600. doi: 10.1186/s12888-022-04231-4.
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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.
Susanna Jernelöv, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adjusted group CBT-i for Depression, Anxiety and PTSD in people with Sleep Problem and Anxiety Disorders, run by Karolinska Institutet 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 3 inclusion and 1 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 19 Aug 2026. 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?
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?
Insomnia Severity Index (ISI) (time frame: Changes from base-line to 6 weeks). 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 NCT04136054, 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 19 Aug 2026.