Better Sleep in Psychiatric Care - ADHD Pilot Study

Sleep Initiation and Maintenance Disorders Clinical Trial

— BeSiP-ADHD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03852966
• Other study ID #: 2015/2078-31/1
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Attention Deficit Disorder
• Attention Deficit Disorder with Hyperactivity
• Disease
• Sleep Initiation and Maintenance Disorders
• Sleep Wake Disorders

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