Better Sleep in Psychiatric Care – ADHD

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 30, 2016

Interventions

  • Behavioral: CBT-i/ADHD
    • Cognitive Behavioral Therapy for insomnia adjusted for patients with ADHD

Arms, Groups and Cohorts

  • Experimental: CBT-i/ADHD
    • Behavioral treatment for sleep problems in ADHD

Clinical Trial Outcome Measures

Primary Measures

  • 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)
  • 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 Measures

  • 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).
  • 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).

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Karolinska Institutet
  • Collaborator
    • Region Stockholm
  • Provider of Information About this Clinical Study
    • Principal Investigator: Susanna Jernelöv, Principal Investigator – Karolinska Institutet
  • Overall Official(s)
    • Susanna Jernelöv, PhD, Principal Investigator, Karolinska Institutet

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