Better Sleep in Psychiatric Care - ADHD.

Not Applicable

Completed

• Conditions: ADHD; Sleep Problem
• Interventions: Behavioral: Adjusted CBT-i for ADHD; Other: Treatment as Usual

• Registration Number: NCT03015636
• Lead Sponsor: Karolinska Institutet

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-12
• Study First Submitted: 2017-01-06
• Study First Submitted QC: 2017-01-09
• Study First Posted: 2017-01-10
• Primary Completion: 2018-11-21
• Study Completion: 2018-11-21
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-21
• Last Update Posted: 2019-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

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

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Exclusion Criteria

• None

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Behavioral: Adjusted CBT-i for ADHD	Adjusted CBT-i for ADHD	Cognitive 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	Treatment as Usual	Treatment as Usual. (After about ten weeks, participants in this condition are offered the experimental group treatment.)

Primary Outcome Measures

Name	Time	Method
Insomnia Severity Index	Changes from base-line to 10 weeks and 3 months	7-item, self-rated questionnaire measuring change in insomnia severity.

Secondary Outcome Measures

Name	Time	Method
Actigraphy	Continuously 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 diary	Changes from base-line to 10 weeks and 3 months	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

Trial Locations

Locations (1)

Department of ADHD, Northern Stockholm Psychiatry; 🇸🇪 Stockholm, Sweden