Better Sleep in Psychiatric Care - ADHD Pilot Study

Study Overview
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Brief Summary
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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.

Official Title
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Better Sleep in Psychiatric Care - ADHD. A Pragmatic Within-group Pilot Study to Develop and Evaluate Effects and Feasibility of a CBT-based Manual for Treating Sleep Problems in Adult Patients With ADHD

Conditions
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Attention Deficit Disorder, Sleep Initiation and Maintenance Disorders, Sleep Wake Disorders

Intervention / Treatment
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* Behavioral: CBT-i/ADHD


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Pragmatic, within-group pilot study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBT-i/ADHD<br>Behavioral treatment for sleep problems in ADHD | Behavioral: CBT-i/ADHD<br>* Cognitive Behavioral Therapy for insomnia adjusted for patients with ADHD<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |