Better Sleep in Psychiatric Care - ADHD Pilot Study

NCT03852966 | Completed

• 1 other identifier: 2015/2078-31/1
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Attention Deficit Disorder; Sleep Initiation and Maintenance Disorders; Sleep Wake Disorders

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Adult ADHD Self-Report Scale (ASRS)

  Change from baseline to 10 weeks

• Adult ADHD Self-Report Scale (ASRS)

  Change from baseline to 24 weeks

Study Arms (1)

CBT-i/ADHD

EXPERIMENTAL

Behavioral treatment for sleep problems in ADHD

Behavioral: CBT-i/ADHD

Interventions

CBT-i/ADHD BEHAVIORAL

Cognitive Behavioral Therapy for insomnia adjusted for patients with ADHD

CBT-i/ADHD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• none

Sponsors & Collaborators

• Karolinska Institutet: lead
• Region Stockholm: collaborator

Study Sites (1)

Department of ADHD, Northern Stockholm Psychiatry

Stockholm, 113 21, Sweden

Location

Related Publications (1)

• 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.

  PMID: 31340804 RESULT

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Sleep Initiation and Maintenance Disorders; Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Susanna Jernelöv, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Pragmatic, within-group pilot study

Study Record Dates

• First Submitted: February 21, 2019
• First Posted: February 25, 2019
• Study Start: September 1, 2015
• Primary Completion: September 30, 2016
• Study Completion: October 31, 2016
• Last Updated: May 16, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)