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Clinical Trials/NCT03852966
NCT03852966
Completed
Not Applicable

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

Karolinska Institutet1 site in 1 country19 target enrollmentSeptember 1, 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Attention Deficit Disorder
Sponsor
Karolinska Institutet
Enrollment
19
Locations
1
Primary Endpoint
Insomnia Severity Index (ISI)
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2015
End Date
October 31, 2016
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Susanna Jernelöv

Principal Investigator

Karolinska Institutet

Eligibility Criteria

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

  • Not provided

Outcomes

Primary Outcomes

Insomnia Severity Index (ISI)

Time Frame: 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 Outcomes

  • Adult ADHD Self-Report Scale (ASRS)(Change from baseline to 24 weeks)

Study Sites (1)

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