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Completed

NCT Number: NCT03852966

Better Sleep in Psychiatric Care - ADHD Pilot Study

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.

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Key information

Conditions

Attention Deficit Disorder Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Dyssomnias Mental Disorders Nervous System Diseases Neurodevelopmental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of ADHD, Northern Stockholm Psychiatry

Stockholm, 113 21, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CBT-i/ADHD

Behavioral

Cognitive Behavioral Therapy for insomnia adjusted for patients with ADHD

Primary outcomes

  1. Insomnia Severity Index (ISI)

    Time frame: Change from baseline to 10 weeks

    7-item self-reported measure of insomnia severity, 0-28 Points. Higher values represents higher severity (worse outcome)

  2. 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

  1. Adult ADHD Self-Report Scale (ASRS)

    Time frame: Change from baseline to 10 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).

  2. Adult ADHD Self-Report Scale (ASRS)

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Region Stockholm

Registry information

Official study 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

Acronym: BeSiP-ADHD

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Feb 25, 2019
Registry last updated
May 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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