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Better Sleep in Psychiatric Care - ADHD Pilot Study (BeSiP-ADHD)

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
CBT-i/ADHD
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of ADHD, Northern Stockholm Psychiatry

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CBT-i/ADHD

Arm Description

Behavioral treatment for sleep problems in ADHD

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Adult ADHD Self-Report Scale (ASRS)
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)
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).

Full Information

First Posted
February 21, 2019
Last Updated
May 10, 2022
Sponsor
Karolinska Institutet
Collaborators
Region Stockholm
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1. Study Identification

Unique Protocol Identification Number
NCT03852966
Brief Title
Better Sleep in Psychiatric Care - ADHD Pilot Study
Acronym
BeSiP-ADHD
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2015 (Actual)
Primary Completion Date
September 30, 2016 (Actual)
Study Completion Date
October 31, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
Region Stockholm

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Disorder, Sleep Initiation and Maintenance Disorders, Sleep Wake Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Pragmatic, within-group pilot study
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CBT-i/ADHD
Arm Type
Experimental
Arm Description
Behavioral treatment for sleep problems in ADHD
Intervention Type
Behavioral
Intervention Name(s)
CBT-i/ADHD
Intervention Description
Cognitive Behavioral Therapy for insomnia adjusted for patients with ADHD
Primary Outcome Measure Information:
Title
Insomnia Severity Index (ISI)
Description
7-item self-reported measure of insomnia severity, 0-28 Points. Higher values represents higher severity (worse outcome)
Time Frame
Change from baseline to 10 weeks
Title
Insomnia Severity Index (ISI)
Description
7-item self-reported measure of insomnia severity, 0-28 Points. Higher values represents higher severity (worse outcome)
Time Frame
Change from baseline to 24 weeks
Secondary Outcome Measure Information:
Title
Adult ADHD Self-Report Scale (ASRS)
Description
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).
Time Frame
Change from baseline to 10 weeks
Title
Adult ADHD Self-Report Scale (ASRS)
Description
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).
Time Frame
Change from baseline to 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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: none
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susanna Jernelöv, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of ADHD, Northern Stockholm Psychiatry
City
Stockholm
ZIP/Postal Code
113 21
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31340804
Citation
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.
Results Reference
result

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Better Sleep in Psychiatric Care - ADHD Pilot Study

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