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
|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|
|Intervention Model:||Parallel Assignment|
|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|
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.
- 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.
- 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.
- 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
- 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.
- 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.
- 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.
- 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.
- 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".
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
|Department of ADHD, Northern Stockholm Psychiatry|
|Stockholm, Sweden, 113 21|
|Principal Investigator:||Susanna Jernelöv, PhD, LP||Karolinska Institutet|