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Trial record 31 of 2195 for:    Symptoms | Parasomnias

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

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ClinicalTrials.gov Identifier: NCT03015636
Recruitment Status : Active, not recruiting
First Posted : January 10, 2017
Last Update Posted : March 12, 2018
Sponsor:
Collaborator:
Department of ADHD, Northern Stockholm Psychiatry
Information provided by (Responsible Party):
Susanna Jernelöv, 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.

Condition or disease Intervention/treatment Phase
Sleep Problem ADHD Behavioral: Adjusted CBT-i for ADHD Other: Treatment as Usual Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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 Start Date : December 2016
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Disorders

Arm Intervention/treatment
Experimental: Behavioral: 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.
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.

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




Primary Outcome Measures :
  1. Insomnia Severity Index [ Time Frame: Changes from base-line to 10 weeks and 3 months ]
    7-item, self-rated questionnaire measuring change in insomnia severity.


Secondary Outcome Measures :
  1. Actigraphy [ Time Frame: 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.

  2. Sleep diary [ Time Frame: 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


Other Outcome Measures:
  1. Brunnsviken brief quality of life scale [ Time Frame: Changes from base-line to 10 weeks and 3 months ]
    12-items self-rating questionnaire measuring quality of life.

  2. Adult ADHD Self-Report Scale [ Time Frame: Changes from base-line to 10 weeks and 3 months ]
    18-items self-report questionnaire measuring ADHD-symptoms.

  3. Dysfunctional Beliefs and Attitudes about Sleep [ Time Frame: Changes from base-line to 10 weeks and 3 months ]
    10-items self-rating questionnaire measuring sleep related cognitions.

  4. Sleep Problems Acceptance Questionnaire [ Time Frame: Changes from base-line to 10 weeks and 3 months ]
    8-items self-rating questionnaire measuring acceptance of sleep problems.

  5. Sleep habits and behaviors [ Time Frame: Changes from base-line to 10 weeks and 3 months ]
    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".



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03015636


Locations
Sweden
Department of ADHD, Northern Stockholm Psychiatry
Stockholm, Sweden, 113 21
Sponsors and Collaborators
Karolinska Institutet
Department of ADHD, Northern Stockholm Psychiatry
Investigators
Principal Investigator: Susanna Jernelöv, PhD, LP Karolinska Institutet

Publications:
Responsible Party: Susanna Jernelöv, PhD, LP, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT03015636     History of Changes
Other Study ID Numbers: 2016/1988-31
First Posted: January 10, 2017    Key Record Dates
Last Update Posted: March 12, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Susanna Jernelöv, Karolinska Institutet:
Cognitive Behaviour Therapy
Psychological Intervention

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Dyssomnias
Sleep Wake Disorders
Parasomnias
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms