NCT03852966|Completed
Better Sleep in Psychiatric Care - ADHD Pilot Study
BeSiP-ADHD
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BeSiP-ADHD
Sponsor study identifier
interventional
19
1 country
1
Study Start
September 1, 2015
Actual (reported)Primary Completion
September 30, 2016
Actual (reported)Study Completion
October 31, 2016
Actual (reported)Comorbidities, including sleep problems, are common in adult Attention Deficit Hyperactivity Disorder (ADHD). Treatment of choice for insomnia is cognitive behavioral therapy (CBT-i), but evidence is lacking for CBT-i in patients with ADHD and sleep problems. The purpose of this study was to investigate if patients at a specialist clinic for ADHD benefit from a group delivered CBT-i treatment; whether insomnia severity improves following this treatment. This pragmatic within-group pilot study with a pre to post and three-month follow-up design was set at a specialist psychiatric out-patient clinic for adult ADHD. As an adjunct to care-as-usual at the clinic, a CBT-i-based group treatment targeting sleep problems prevalent in the ADHD-population, designed for patients with executive difficulties, was offered as 10 weekly 90-minute group sessions and scheduled telephone support. All outcome measures were subjectively reported by participants. Data analyzed with dependent t-tests according to intent-to-treat.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 31, 2016
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 1, 2015
Actual (reported)September 30, 2016
Actual (reported)October 31, 2016
Actual (reported)February 21, 2019
Actual (reported)February 25, 2019
Actual (reported)Insomnia Severity Index (ISI)
7-item self-reported measure of insomnia severity, 0-28 Points. Higher values represents higher severity (worse outcome)
Change from baseline to 10 weeks
Insomnia Severity Index (ISI)
7-item self-reported measure of insomnia severity, 0-28 Points. Higher values represents higher severity (worse outcome)
Change from baseline to 24 weeks
Adult ADHD Self-Report Scale (ASRS)
Change from baseline to 10 weeks
Adult ADHD Self-Report Scale (ASRS)
Change from baseline to 24 weeks
Behavioral treatment for sleep problems in ADHD
Cognitive Behavioral Therapy for insomnia adjusted for patients with ADHD
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Department of ADHD, Northern Stockholm Psychiatry
Stockholm, 113 21, Sweden
Jernelov S, Larsson Y, Llenas M, Nasri B, Kaldo V. Effects and clinical feasibility of a behavioral treatment for sleep problems in adult attention deficit hyperactivity disorder (ADHD): a pragmatic within-group pilot evaluation. BMC Psychiatry. 2019 Jul 24;19(1):226. doi: 10.1186/s12888-019-2216-2.
Susanna Jernelöv, PhD
Karolinska Institutet
19 participants (actual enrollment reported by the registry).
First Submitted
February 21, 2019
First Posted
February 25, 2019
Study Start
September 1, 2015
Actual (reported)A Randomized Controlled Study of Cognitive Behavioral Therapy for Adults With Attention Deficit Disorder
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Primary Completion
September 30, 2016
Actual (reported)Study Completion
October 31, 2016
Actual (reported)Last Updated
May 16, 2022
Record last verified: 2022-05
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Source: ClinicalTrials.gov.
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