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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03852966
Other study ID # 2015/2078-31/1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2015
Est. completion date October 31, 2016

Study information

Verified date May 2022
Source Karolinska Institutet
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 19
Est. completion date October 31, 2016
Est. primary completion date September 30, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - being a patient at the clinic (i.e. having a diagnosis of AD(H)D) - self-reported sleep problems - returning pre-treatment questionnaires and signed consent form Exclusion Criteria: - none

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
CBT-i/ADHD
Cognitive Behavioral Therapy for insomnia adjusted for patients with ADHD

Locations

Country Name City State
Sweden Department of ADHD, Northern Stockholm Psychiatry Stockholm

Sponsors (2)

Lead Sponsor Collaborator
Karolinska Institutet Region Stockholm

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Jernelöv 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 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Secondary Adult ADHD Self-Report Scale (ASRS) 18-item self-reported measure of inattention and hyperactivity symptoms. Total score 0-72. Subscale inattention/hyperactivity 0-36 points per scale. Higher scores represents more severe symptoms (worse outcome). Change from baseline to 10 weeks
Secondary Adult ADHD Self-Report Scale (ASRS) 18-item self-reported measure of inattention and hyperactivity symptoms. Total score 0-72. Subscale inattention/hyperactivity 0-36 points per scale. Higher scores represents more severe symptoms (worse outcome). Change from baseline to 24 weeks
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