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Better Sleep in Psychiatric Care - ADHD. (BSIP-ADHD)

Primary Purpose

Sleep Problem, ADHD

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Adjusted CBT-i for ADHD
Treatment as Usual
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Problem focused on measuring Cognitive Behaviour Therapy, Psychological Intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Sites / Locations

  • Department of ADHD, Northern Stockholm Psychiatry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Behavioral: Adjusted CBT-i for ADHD

Treatment as Usual

Arm Description

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. (After about ten weeks, participants in this condition are offered the experimental group treatment.)

Outcomes

Primary Outcome Measures

Insomnia Severity Index
7-item, self-rated questionnaire measuring change in insomnia severity.

Secondary Outcome Measures

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.
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

Full Information

First Posted
January 6, 2017
Last Updated
October 21, 2019
Sponsor
Karolinska Institutet
Collaborators
Department of ADHD, Northern Stockholm Psychiatry
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1. Study Identification

Unique Protocol Identification Number
NCT03015636
Brief Title
Better Sleep in Psychiatric Care - ADHD.
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
December 2016 (undefined)
Primary Completion Date
November 21, 2018 (Actual)
Study Completion Date
November 21, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
Department of ADHD, Northern Stockholm Psychiatry

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Problem, ADHD
Keywords
Cognitive Behaviour Therapy, Psychological Intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Behavioral: Adjusted CBT-i for ADHD
Arm Type
Experimental
Arm Description
Cognitive Behavioral group intervention for sleep problems in ADHD, based on Cognitive Behavioral Therapy for insomnia and behavioral treatment for Sleep Phase Disorders.
Arm Title
Treatment as Usual
Arm Type
Other
Arm Description
Treatment as Usual. (After about ten weeks, participants in this condition are offered the experimental group treatment.)
Intervention Type
Behavioral
Intervention Name(s)
Adjusted CBT-i for ADHD
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Treatment as Usual
Intervention Description
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.
Primary Outcome Measure Information:
Title
Insomnia Severity Index
Description
7-item, self-rated questionnaire measuring change in insomnia severity.
Time Frame
Changes from base-line to 10 weeks and 3 months
Secondary Outcome Measure Information:
Title
Actigraphy
Description
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.
Time Frame
Continuously from treatment start (week 1) to the last week of treatment (week 10)
Title
Sleep diary
Description
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
Time Frame
Changes from base-line to 10 weeks and 3 months
Other Pre-specified Outcome Measures:
Title
Brunnsviken brief quality of life scale
Description
12-items self-rating questionnaire measuring quality of life.
Time Frame
Changes from base-line to 10 weeks and 3 months
Title
Adult ADHD Self-Report Scale
Description
18-items self-report questionnaire measuring ADHD-symptoms.
Time Frame
Changes from base-line to 10 weeks and 3 months
Title
Dysfunctional Beliefs and Attitudes about Sleep
Description
10-items self-rating questionnaire measuring sleep related cognitions.
Time Frame
Changes from base-line to 10 weeks and 3 months
Title
Sleep Problems Acceptance Questionnaire
Description
8-items self-rating questionnaire measuring acceptance of sleep problems.
Time Frame
Changes from base-line to 10 weeks and 3 months
Title
Sleep habits and behaviors
Description
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".
Time Frame
Changes from base-line to 10 weeks and 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Being a patient at the ADHD-clinics Northern Stockholm Psychiatry Experiencing sleep problems (subjective report) Exclusion Criteria: None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susanna Jernelöv, PhD, LP
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of ADHD, Northern Stockholm Psychiatry
City
Stockholm
ZIP/Postal Code
113 21
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
11438246
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.
Results Reference
background
PubMed Identifier
26886248
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.
Results Reference
background
PubMed Identifier
16923651
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.
Results Reference
background
PubMed Identifier
10719130
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.
Results Reference
background
PubMed Identifier
26085302
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.
Results Reference
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Better Sleep in Psychiatric Care - ADHD.

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