Clinical trial NCT03015636: Better Sleep in Psychiatric Care - ADHD.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Problem
ADHD
Keywords: Cognitive Behaviour Therapy
Psychological Intervention
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Department of ADHD, Northern Stockholm Psychiatry
First posted: 2017-01-10
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* None

Primary outcomes:
measure: Insomnia Severity Index
timeFrame: Changes from base-line to 10 weeks and 3 months
Secondary outcomes:
measure: Actigraphy
timeFrame: Continuously from treatment start (week 1) to the last week of treatment (week 10)
measure: Sleep diary
timeFrame: Changes from base-line to 10 weeks and 3 months
Other outcomes:
measure: Brunnsviken brief quality of life scale
timeFrame: Changes from base-line to 10 weeks and 3 months
measure: Adult ADHD Self-Report Scale
timeFrame: Changes from base-line to 10 weeks and 3 months
measure: Dysfunctional Beliefs and Attitudes about Sleep
timeFrame: Changes from base-line to 10 weeks and 3 months
measure: Sleep Problems Acceptance Questionnaire
timeFrame: Changes from base-line to 10 weeks and 3 months
measure: Sleep habits and behaviors
timeFrame: Changes from base-line to 10 weeks and 3 months
Locations:
city: Stockholm
country: Sweden
facility: Department of ADHD, Northern Stockholm Psychiatry
Study officials:
affiliation: Karolinska Institutet
name: Susanna Jernelöv, PhD, LP
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Lindner 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.
citation: Adler 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.
citation: Espie 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.
citation: Bothelius 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.