Better Sleep in Psychiatric Care - ADHD.

ADHD Clinical Trial

— BSIP-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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03015636
• Other study ID #: 2016/1988-31
• Status: Completed
• Phase: N/A
• Start date: December 2016
• Est. completion date: November 21, 2018

Study information

• Verified date: October 2019
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: November 21, 2018
• Est. primary completion date: November 21, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Being a patient at the ADHD-clinics Northern Stockholm Psychiatry

• Experiencing sleep problems (subjective report)

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• ADHD
• Dyssomnias
• Parasomnias
• Sleep Problem
• Sleep Wake Disorders

Intervention

Behavioral:
• Adjusted 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.

Other:
• Treatment 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.

Locations

Country	Name	City	State
Sweden	Department of ADHD, Northern Stockholm Psychiatry	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Department of ADHD, Northern Stockholm Psychiatry

Country where clinical trial is conducted

Sweden, 

References & Publications (5)

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. — View Citation

Bastien CH, Vallières A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001 Jul;2(4):297-307. — View Citation

Bothelius K, Jernelöv 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. — View 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. — View Citation

Lindner P, Frykheden O, Forsström D, Andersson E, Ljótsson 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Brunnsviken brief quality of life scale	12-items self-rating questionnaire measuring quality of life.	Changes from base-line to 10 weeks and 3 months
Other	Adult ADHD Self-Report Scale	18-items self-report questionnaire measuring ADHD-symptoms.	Changes from base-line to 10 weeks and 3 months
Other	Dysfunctional Beliefs and Attitudes about Sleep	10-items self-rating questionnaire measuring sleep related cognitions.	Changes from base-line to 10 weeks and 3 months
Other	Sleep Problems Acceptance Questionnaire	8-items self-rating questionnaire measuring acceptance of sleep problems.	Changes from base-line to 10 weeks and 3 months
Other	Sleep habits and behaviors	Self-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".	Changes from base-line to 10 weeks and 3 months
Primary	Insomnia Severity Index	7-item, self-rated questionnaire measuring change in insomnia severity.	Changes from base-line to 10 weeks and 3 months
Secondary	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.	Continuously from treatment start (week 1) to the last week of treatment (week 10)
Secondary	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	Changes from base-line to 10 weeks and 3 months