Attention Deficit DisorderBeSiP-ADHDNCT03852966
Better Sleep in Psychiatric Care - ADHD Pilot Study
A study testing CBT-i/ADHD in people with Attention Deficit Disorder and Sleep Initiation and Maintenance Disorders, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
Comorbidities, including sleep problems, are common in adult Attention Deficit Hyperactivity Disorder (ADHD). Treatment of choice for insomnia is cognitive behavioral therapy (CBT-i), but evidence is lacking for CBT-i in patients with ADHD and sleep problems. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Attention Deficit Disorder, Sleep Initiation and Maintenance Disorders, Sleep Wake Disorders
- What is being tested?
- CBT-i/ADHD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteSweden
- Study dates
- 1 Sep 2015to 31 Oct 2016
- 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 clinic (i.e. having a diagnosis of AD(H)D)
- self-reported sleep problems
- returning pre-treatment questionnaires and signed consent form
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 Pragmatic Within-group Pilot Study to Develop and Evaluate Effects and Feasibility of a CBT-based Manual for Treating Sleep Problems in Adult Patients With ADHD
Comorbidities, including sleep problems, are common in adult Attention Deficit Hyperactivity Disorder (ADHD). Treatment of choice for insomnia is cognitive behavioral therapy (CBT-i), but evidence is lacking for CBT-i in patients with ADHD and sleep problems.
The purpose of this study was to investigate if patients at a specialist clinic for ADHD benefit from a group delivered CBT-i treatment; whether insomnia severity improves following this treatment.
Read more
This pragmatic within-group pilot study with a pre to post and three-month follow-up design was set at a specialist psychiatric out-patient clinic for adult ADHD.
As an adjunct to care-as-usual at the clinic, a CBT-i-based group treatment targeting sleep problems prevalent in the ADHD-population, designed for patients with executive difficulties, was offered as 10 weekly 90-minute group sessions and scheduled telephone support.
All outcome measures were subjectively reported by participants. Data analyzed with dependent t-tests according to intent-to-treat.
- Conditions
- Attention Deficit Disorder, Sleep Initiation and Maintenance Disorders, Sleep Wake Disorders
- Being tested
- CBT-i/ADHD
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Sleep Initiation and Maintenance Disorders, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT-i/ADHDBehavioural
Cognitive Behavioral Therapy for insomnia adjusted for patients with ADHD
| Study group | Role | What they receive |
|---|---|---|
| CBT-i/ADHD | Experimental | Behavioral treatment for sleep problems in ADHD Receives: Behavioral: CBT-i/ADHD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia Severity Index (ISI)
7-item self-reported measure of insomnia severity, 0-28 Points. Higher values represents higher severity (worse outcome)
Measured: Change from baseline to 10 weeks
Insomnia Severity Index (ISI)
7-item self-reported measure of insomnia severity, 0-28 Points. Higher values represents higher severity (worse outcome)
Measured: Change from baseline to 24 weeks
Secondary outcomes (2)
Adult ADHD Self-Report Scale (ASRS)
18-item self-reported measure of inattention and hyperactivity symptoms. Total score 0-72. Subscale inattention/hyperactivity 0-36 points per scale. Higher scores represents more severe symptoms (worse outcome).
Measured: Change from baseline to 10 weeks
Adult ADHD Self-Report Scale (ASRS)
18-item self-reported measure of inattention and hyperactivity symptoms. Total score 0-72. Subscale inattention/hyperactivity 0-36 points per scale. Higher scores represents more severe symptoms (worse outcome).
Measured: Change from baseline to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2019
- Study start1 Sep 2015
- Primary completion30 Sep 2016
- Study completion31 Oct 2016
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 Attention Deficit DisorderStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Pragmatic, within-group pilot study
- Masking
- None (open label)
- Enrolment
- 19 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
- NCT03852966
- Sponsor's protocol ID
- 2015/2078-31/1
- Acronym
- BeSiP-ADHD
- Status last verified
- May 2022
- First submitted
- 21 Feb 2019
- Last updated
- 16 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jernelov S, Larsson Y, Llenas M, Nasri B, Kaldo V. Effects and clinical feasibility of a behavioral treatment for sleep problems in adult attention deficit hyperactivity disorder (ADHD): a pragmatic within-group pilot evaluation. BMC Psychiatry. 2019 Jul 24;19(1):226. doi: 10.1186/s12888-019-2216-2.
PubMed 31340804
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Better Sleep in Psychiatric Care - ADHD. A Pragmatic Within-group Pilot Study to Develop and Evaluate Effects and Feasibility of a CBT-based Manual for Treating Sleep Problems in Adult Patients With ADHD
- ClinicalTrials.gov ID
- NCT03852966
- Acronym / sponsor ID
- BeSiP-ADHD / 2015/2078-31/1
- Conditions
- Attention Deficit Disorder, Sleep Initiation and Maintenance Disorders, Sleep Wake Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Region Stockholm
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- 30 Sep 2016 (actual)
- Study completion
- 31 Oct 2016 (actual)
- First posted
- 25 Feb 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.
Comorbidities, including sleep problems, are common in adult Attention Deficit Hyperactivity Disorder (ADHD). Treatment of choice for insomnia is cognitive behavioral therapy (CBT-i), but evidence is lacking for CBT-i in patients with ADHD and sleep problems.
The purpose of this study was to investigate if patients at a specialist clinic for ADHD benefit from a group delivered CBT-i treatment; whether insomnia severity improves following this treatment.
This pragmatic within-group pilot study with a pre to post and three-month follow-up design was set at a specialist psychiatric out-patient clinic for adult ADHD.
As an adjunct to care-as-usual at the clinic, a CBT-i-based group treatment targeting sleep problems prevalent in the ADHD-population, designed for patients with executive difficulties, was offered as 10 weekly 90-minute group sessions and scheduled telephone support.
All outcome measures were subjectively reported by participants. Data analyzed with dependent t-tests according to intent-to-treat.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pragmatic, within-group pilot study
| Arm | Type | Receives |
|---|---|---|
| CBT-i/ADHD | Experimental | Behavioral: CBT-i/ADHDBehavioral treatment for sleep problems in ADHD |
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 clinic (i.e. having a diagnosis of AD(H)D)
- self-reported sleep problems
- returning pre-treatment questionnaires and signed consent form
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 |
|---|---|---|
| CBT-i/ADHDCognitive Behavioral Therapy for insomnia adjusted for patients with ADHD | Behavioural | CBT-i/ADHD |
Primary outcome
Insomnia Severity Index (ISI)
Time frame: Change from baseline to 10 weeks
7-item self-reported measure of insomnia severity, 0-28 Points. Higher values represents higher severity (worse outcome)
Insomnia Severity Index (ISI)
Time frame: Change from baseline to 24 weeks
7-item self-reported measure of insomnia severity, 0-28 Points. Higher values represents higher severity (worse outcome)
2 secondary outcomes
Adult ADHD Self-Report Scale (ASRS)
Time frame: Change from baseline to 10 weeks
Adult ADHD Self-Report Scale (ASRS)
Time frame: Change from baseline to 24 weeks
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 16 May 2022.
- Results publication: PubMed 31340804Jernelov S, Larsson Y, Llenas M, Nasri B, Kaldo V. Effects and clinical feasibility of a behavioral treatment for sleep problems in adult attention deficit hyperactivity disorder (ADHD): a pragmatic within-group pilot evaluation. BMC Psychiatry. 2019 Jul 24;19(1):226. doi: 10.1186/s12888-019-2216-2.
- 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.
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 CBT-i/ADHD in people with Attention Deficit Disorder and Sleep Initiation and Maintenance 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 16 May 2022. 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: Change from baseline to 10 weeks). The study lists 2 primary outcomes in all. 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 NCT03852966, 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 16 May 2022.