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Better Sleep in Psychiatric Care - ADHD.

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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03015636
Acronym
BSIP-ADHD
Enrollment
58
Registered
2017-01-10
Start date
2016-12-31
Completion date
2018-11-21
Last updated
2019-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ADHD, Sleep Problem

Keywords

Cognitive Behaviour Therapy, Psychological Intervention

Brief 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. 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.

Interventions

BEHAVIORALAdjusted CBT-i for ADHD

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.

OTHERTreatment as Usual

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.

Sponsors

Department of ADHD, Northern Stockholm Psychiatry
CollaboratorUNKNOWN
Karolinska Institutet
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Being a patient at the ADHD-clinics Northern Stockholm Psychiatry * Experiencing sleep problems (subjective report)

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
Insomnia Severity IndexChanges from base-line to 10 weeks and 3 months7-item, self-rated questionnaire measuring change in insomnia severity.

Secondary

MeasureTime frameDescription
ActigraphyContinuously from treatment start (week 1) to the last week of treatment (week 10)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.
Sleep diaryChanges from base-line to 10 weeks and 3 monthsDaily 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

Other

MeasureTime frameDescription
Dysfunctional Beliefs and Attitudes about SleepChanges from base-line to 10 weeks and 3 months10-items self-rating questionnaire measuring sleep related cognitions.
Sleep Problems Acceptance QuestionnaireChanges from base-line to 10 weeks and 3 months8-items self-rating questionnaire measuring acceptance of sleep problems.
Sleep habits and behaviorsChanges from base-line to 10 weeks and 3 monthsSelf-rating questionnaire regarding the use of sleep promoting behaviors. The questionnaire was constructed for the current project and consists of two parts. The first part includes 16 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 other 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.
Brunnsviken brief quality of life scaleChanges from base-line to 10 weeks and 3 months12-items self-rating questionnaire measuring quality of life.
Adult ADHD Self-Report ScaleChanges from base-line to 10 weeks and 3 months18-items self-report questionnaire measuring ADHD-symptoms.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026