Sleep ProblemBSIP-ADHDNCT03015636
Better Sleep in Psychiatric Care - ADHD.
A study testing Adjusted CBT-i for ADHD and Treatment as Usual in people with Sleep Problem and ADHD, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
Cognitive Behavioral Therapy (CBT) is treatment of choice for insomnia (CBT-i). 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 ADHD is a patient group with 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, ADHD
- What is being tested?
- Adjusted CBT-i for ADHD and Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteSweden
- Study dates
- Dec 2016to 21 Nov 2018
- 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 ADHD-clinics Northern Stockholm Psychiatry
- Experiencing sleep problems (subjective report)
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of ADHD, Northern Stockholm Psychiatry
Stockholm, 113 21
About this study
Official title: Better Sleep in Psychiatric Care - ADHD. A Randomized Naturalistic Study of a Psychological Group Treatment for Sleep Problems in Psychiatric Patients With Attention Deficit Hyperactivity Disorder.
Cognitive Behavioral Therapy (CBT) is treatment of choice for insomnia (CBT-i). 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 ADHD is a patient group with high levels of sleep difficulties. Sleep problems in this patient group can be both more general such as insomnia, but can also be related to the ADHD itself and to the use of ADHD medication. In a previous pilot study, the investigators developed a version of CBT-i that would target sleep problems in this population. The basis was CBT-i, but with more emphasis on sleep promoting behaviors specific to ADHD (e.g. appropriate timing of ADHD-medication), techniques that would also alleviate sleep phase problems, (e.g. the systematic use of light and darkness), and techniques to target more general sleep disturbing habits (e.g. not winding down before bed time), that are also common in patients with ADHD. This treatment was well tolerated and gave moderate 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 symptoms of ADHD in patients at the ADHD-clinics, Northern Stockholm Psychiatry, Sweden.
- Conditions
- Sleep Problem, ADHD
- Being tested
- Adjusted CBT-i for ADHD, Treatment as Usual
- Keywords
- Cognitive Behaviour Therapy, Psychological Intervention
- Medical subject headings
- Parasomnias, Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adjusted CBT-i for ADHDBehavioural
This is a version of CBT for insomnia (CBT-i) developed during the pilot phase of this Project. Traditional CBT-i is adjusted for use in the adult ADHD population. This behavioral intervention adresses not only traditional aspects of insomnia, but also sleep phase problems and other aspects of sleep specifically relevant to the ADHD-population. Treatment is given as 10 weekly group sessions with telephone calls from the therapist between sessions to increase adherence and adress individual patient needs.
Treatment as UsualOther
Usual care at the ADHD-clinic. This mostly entails managing pharmacological treatment for ADHD, comorbid psychiatric problems and/or sleep problems. The clinic also provides different group treatments, for instance mindfulness groups and groups for developing behavioral strategies for managing ADHD symptoms, and individual therapy.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral: Adjusted CBT-i for ADHD | Experimental | Cognitive Behavioral group intervention for sleep problems in ADHD, based on Cognitive Behavioral Therapy for insomnia and behavioral treatment for Sleep Phase Disorders. Receives: Behavioral: Adjusted CBT-i for ADHD |
| Treatment as Usual | Other | Treatment as Usual. (After about ten weeks, participants in this condition are offered the experimental group treatment.) Receives: Other: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia Severity Index
7-item, self-rated questionnaire measuring change in insomnia severity.
Measured: Changes from base-line to 10 weeks and 3 months
Secondary outcomes (2)
Actigraphy
An actigraph is placed on the participant's arm for one week. It measures participants' activity in the form of movements. It can be used for acquiring data on sleep and daytime activity, including calculated sleep latency, total sleep time, sleep efficiency, wake after sleep onset, variability in sleep timing and daytime activity.
Measured: Continuously from treatment start (week 1) to the last week of treatment (week 10)
Sleep diary
Daily self-ratings on a number of sleep parameters, resulting in several measures including sleep latency, wake after sleep onset, total sleep time, sleep efficiency, subjective sleep quality and variability in sleep timing
Measured: Changes from base-line to 10 weeks and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2017 (estimated)
- Study startDec 2016
- Primary completion21 Nov 2018
- Study completion21 Nov 2018
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 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
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Department of ADHD, Northern Stockholm Psychiatry
- Responsible party
- Principal investigator, Susanna Jernelöv, Karolinska Institutet
- Investigators
- Susanna Jernelöv, PhD, LP, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03015636
- Sponsor's protocol ID
- 2016/1988-31
- Acronym
- BSIP-ADHD
- Status last verified
- Oct 2019
- First submitted
- 6 Jan 2017
- Last updated
- 23 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Bastien CH, Vallieres A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001 Jul;2(4):297-307. doi: 10.1016/s1389-9457(00)00065-4.
PubMed 11438246Lindner P, Frykheden O, Forsstrom D, Andersson E, Ljotsson B, Hedman E, Andersson G, Carlbring P. The Brunnsviken Brief Quality of Life Scale (BBQ): Development and Psychometric Evaluation. Cogn Behav Ther. 2016 Apr;45(3):182-95. doi: 10.1080/16506073.2016.1143526. Epub 2016 Feb 17.
PubMed 26886248Adler LA, Spencer T, Faraone SV, Kessler RC, Howes MJ, Biederman J, Secnik K. Validity of pilot Adult ADHD Self- Report Scale (ASRS) to Rate Adult ADHD symptoms. Ann Clin Psychiatry. 2006 Jul-Sep;18(3):145-8. doi: 10.1080/10401230600801077.
PubMed 16923651Espie CA, Inglis SJ, Harvey L, Tessier S. Insomniacs' attributions. psychometric properties of the Dysfunctional Beliefs and Attitudes about Sleep Scale and the Sleep Disturbance Questionnaire. J Psychosom Res. 2000 Feb;48(2):141-8. doi: 10.1016/s0022-3999(99)00090-2.
PubMed 10719130Bothelius K, Jernelov S, Fredrikson M, McCracken LM, Kaldo V. Measuring Acceptance of Sleep Difficulties: The Development of the Sleep Problem Acceptance Questionnaire. Sleep. 2015 Nov 1;38(11):1815-22. doi: 10.5665/sleep.5170.
PubMed 26085302
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Better Sleep in Psychiatric Care - ADHD. A Randomized Naturalistic Study of a Psychological Group Treatment for Sleep Problems in Psychiatric Patients With Attention Deficit Hyperactivity Disorder.
- ClinicalTrials.gov ID
- NCT03015636
- Acronym / sponsor ID
- BSIP-ADHD / 2016/1988-31
- Conditions
- Sleep Problem, ADHD
- Keywords
- Cognitive Behaviour Therapy, Psychological Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Department of ADHD, Northern Stockholm Psychiatry
- Study start
- Dec 2016
- Primary completion
- 21 Nov 2018 (actual)
- Study completion
- 21 Nov 2018 (actual)
- First posted
- 10 Jan 2017 (estimated)
- 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 (CBT-i). 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 ADHD is a patient group with high levels of sleep difficulties. Sleep problems in this patient group can be both more general such as insomnia, but can also be related to the ADHD itself and to the use of ADHD medication. In a previous pilot study, the investigators developed a version of CBT-i that would target sleep problems in this population. The basis was CBT-i, but with more emphasis on sleep promoting behaviors specific to ADHD (e.g. appropriate timing of ADHD-medication), techniques that would also alleviate sleep phase problems, (e.g. the systematic use of light and darkness), and techniques to target more general sleep disturbing habits (e.g. not winding down before bed time), that are also common in patients with ADHD. This treatment was well tolerated and gave moderate 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 symptoms of ADHD in patients at the ADHD-clinics, Northern Stockholm Psychiatry, Sweden.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral: Adjusted CBT-i for ADHD | Experimental | Behavioral: Adjusted CBT-i for ADHDCognitive Behavioral group intervention for sleep problems in ADHD, based on Cognitive Behavioral Therapy for insomnia and behavioral treatment for Sleep Phase Disorders. |
| Treatment as Usual | Other | Other: Treatment as UsualTreatment as Usual. (After about ten weeks, 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 (2 listed)
- Being a patient at the ADHD-clinics Northern Stockholm Psychiatry
- Experiencing sleep problems (subjective report)
Key exclusion criteria (1 listed)
- None
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 CBT-i for ADHDThis is a version of CBT for insomnia (CBT-i) developed during the pilot phase of this Project. Traditional CBT-i is adjusted for use in the adult ADHD population. This behavioral intervention adresses not only traditional aspects of insomnia, but also sleep phase problems and other aspects of sleep specifically relevant to the ADHD-population. Treatment is given as 10 weekly group sessions with telephone calls from the therapist between sessions to increase adherence and adress individual patient needs. | Behavioural | Behavioral: Adjusted CBT-i for ADHD |
| Treatment as UsualUsual care at the ADHD-clinic. This mostly entails managing pharmacological treatment for ADHD, comorbid psychiatric problems and/or sleep problems. The clinic also provides different group treatments, for instance mindfulness groups and groups for developing behavioral strategies for managing ADHD symptoms, and individual therapy. | Other | Treatment as Usual |
Primary outcome
Insomnia Severity Index
Time frame: Changes from base-line to 10 weeks and 3 months
7-item, self-rated questionnaire measuring change in insomnia severity.
2 secondary outcomes
Actigraphy
Time frame: Continuously from treatment start (week 1) to the last week of treatment (week 10)
Sleep diary
Time frame: Changes from base-line to 10 weeks and 3 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 23 Oct 2019.
- Background: PubMed 11438246Bastien CH, Vallieres A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001 Jul;2(4):297-307. doi: 10.1016/s1389-9457(00)00065-4.
- Background: PubMed 26886248Lindner P, Frykheden O, Forsstrom D, Andersson E, Ljotsson B, Hedman E, Andersson G, Carlbring P. The Brunnsviken Brief Quality of Life Scale (BBQ): Development and Psychometric Evaluation. Cogn Behav Ther. 2016 Apr;45(3):182-95. doi: 10.1080/16506073.2016.1143526. Epub 2016 Feb 17.
- Background: PubMed 16923651Adler LA, Spencer T, Faraone SV, Kessler RC, Howes MJ, Biederman J, Secnik K. Validity of pilot Adult ADHD Self- Report Scale (ASRS) to Rate Adult ADHD symptoms. Ann Clin Psychiatry. 2006 Jul-Sep;18(3):145-8. doi: 10.1080/10401230600801077.
- Background: PubMed 10719130Espie CA, Inglis SJ, Harvey L, Tessier S. Insomniacs' attributions. psychometric properties of the Dysfunctional Beliefs and Attitudes about Sleep Scale and the Sleep Disturbance Questionnaire. J Psychosom Res. 2000 Feb;48(2):141-8. doi: 10.1016/s0022-3999(99)00090-2.
- Background: PubMed 26085302Bothelius K, Jernelov S, Fredrikson M, McCracken LM, Kaldo V. Measuring Acceptance of Sleep Difficulties: The Development of the Sleep Problem Acceptance Questionnaire. Sleep. 2015 Nov 1;38(11):1815-22. doi: 10.5665/sleep.5170.
- Individual participant dataSharing planned: Undecided
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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, LP 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 CBT-i for ADHD and Treatment as Usual in people with Sleep Problem and ADHD, 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 2 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 23 Oct 2019. 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 (time frame: Changes from base-line to 10 weeks and 3 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 NCT03015636, 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 Oct 2019.