Better Sleep in Psychiatric Care - ADHD Pilot Study (BeSiP-ADHD)

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

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.

Study Overview

• Status: Completed
• Conditions: Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders; Attention Deficit Disorder
• Intervention / Treatment: Behavioral: CBT-i/ADHD

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 113 21
    • Department of ADHD, Northern Stockholm Psychiatry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Region Stockholm

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2015
• Primary Completion (Actual): September 30, 2016
• Study Completion (Actual): October 31, 2016

Study Registration Dates

• First Submitted: February 21, 2019
• First Submitted That Met QC Criteria: February 21, 2019
• First Posted (Actual): February 25, 2019

Study Record Updates

• Last Update Posted (Actual): May 16, 2022
• Last Update Submitted That Met QC Criteria: May 10, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Neurologic Manifestations; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Disease; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders; Attention Deficit Disorder with Hyperactivity
• Other Study ID Numbers: 2015/2078-31/1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No