NCT03015636

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 6, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 10, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 21, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 21, 2018

Completed
Last Updated

October 23, 2019

Status Verified

October 1, 2019

Enrollment Period

2 years

First QC Date

January 6, 2017

Last Update Submit

October 21, 2019

Conditions

Sleep ProblemADHD

Keywords

Cognitive Behaviour TherapyPsychological Intervention

Outcome Measures

Primary Outcomes (1)

  • Insomnia Severity Index

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

    Changes from base-line to 10 weeks and 3 months

Secondary Outcomes (2)

  • Actigraphy

    Continuously from treatment start (week 1) to the last week of treatment (week 10)

  • Sleep diary

    Changes from base-line to 10 weeks and 3 months

Other Outcomes (5)

  • Brunnsviken brief quality of life scale

    Changes from base-line to 10 weeks and 3 months

  • Adult ADHD Self-Report Scale

    Changes from base-line to 10 weeks and 3 months

  • Dysfunctional Beliefs and Attitudes about Sleep

    Changes from base-line to 10 weeks and 3 months

  • +2 more other outcomes

Study Arms (2)

Behavioral: Adjusted CBT-i for ADHD

EXPERIMENTAL

Cognitive Behavioral group intervention for sleep problems in ADHD, based on Cognitive Behavioral Therapy for insomnia and behavioral treatment for Sleep Phase Disorders.

Behavioral: Adjusted CBT-i for ADHD

Treatment as Usual

OTHER

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

Other: Treatment as Usual

Interventions

Adjusted CBT-i for ADHDBEHAVIORAL

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.

Behavioral: Adjusted CBT-i for ADHD
Treatment as UsualOTHER

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.

Treatment as Usual

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of ADHD, Northern Stockholm Psychiatry

Stockholm, 113 21, Sweden

Location

Related Publications (5)

  • 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.

    PMID: 11438246BACKGROUND

  • 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.

    PMID: 26886248BACKGROUND

  • 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.

    PMID: 16923651BACKGROUND

  • 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.

    PMID: 10719130BACKGROUND

  • 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.

    PMID: 26085302BACKGROUND

MeSH Terms

Conditions

ParasomniasAttention Deficit Disorder with Hyperactivity

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Sleep Wake DisordersNervous System DiseasesMental DisordersAttention Deficit and Disruptive Behavior DisordersNeurodevelopmental Disorders

Study Officials

  • Susanna Jernelöv, PhD, LP

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, LP

Study Record Dates

First Submitted

January 6, 2017

First Posted

January 10, 2017

Study Start

December 1, 2016

Primary Completion

November 21, 2018

Study Completion

November 21, 2018

Last Updated

October 23, 2019

Record last verified: 2019-10

Locations

SE(1)