Better Sleep in Psychiatric Care - ADHD Pilot Study

NCT ID: NCT03852966

Last Updated: 2022-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-01

Study Completion Date

2016-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Attention Deficit Disorder Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Pragmatic, within-group pilot study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CBT-i/ADHD

Behavioral treatment for sleep problems in ADHD

Group Type EXPERIMENTAL

CBT-i/ADHD

Intervention Type BEHAVIORAL

Cognitive Behavioral Therapy for insomnia adjusted for patients with ADHD

Interventions

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CBT-i/ADHD

Cognitive Behavioral Therapy for insomnia adjusted for patients with ADHD

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Region Stockholm

OTHER_GOV

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Susanna Jernelöv

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Susanna Jernelöv, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

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Department of ADHD, Northern Stockholm Psychiatry

Stockholm, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type RESULT
PMID: 31340804 (View on PubMed)

Other Identifiers

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2015/2078-31/1

Identifier Type: -

Identifier Source: org_study_id

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