Better Sleep in Psychiatric Care - ADHD Pilot Study

Not Applicable

Completed

• Conditions: Sleep Wake Disorders; Attention Deficit Disorder; Sleep Initiation and Maintenance Disorders
• Interventions: Behavioral: CBT-i/ADHD

• Registration Number: NCT03852966
• Lead Sponsor: Karolinska Institutet

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09-01
• Primary Completion: 2016-09-30
• Study Completion: 2016-10-31
• Study First Submitted: 2019-02-21
• Study First Submitted QC: 2019-02-21
• Study First Posted: 2019-02-25
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-10
• Last Update Posted: 2022-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

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Exclusion Criteria

• none

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CBT-i/ADHD	CBT-i/ADHD	Behavioral treatment for sleep problems in ADHD

Primary Outcome Measures

Name	Time	Method
Insomnia Severity Index (ISI)	Change from baseline to 24 weeks	7-item self-reported measure of insomnia severity, 0-28 Points. Higher values represents higher severity (worse outcome)

Secondary Outcome Measures

Name	Time	Method
Adult ADHD Self-Report Scale (ASRS)	Change from baseline to 24 weeks	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).

Trial Locations

Locations (1)

Department of ADHD, Northern Stockholm Psychiatry; 🇸🇪 Stockholm, Sweden