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Digital Psychological Self-care for Sleep Problems

Primary Purpose

Chronic Insomnia

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

About this trial

This is an interventional treatment trial for Chronic Insomnia focused on measuring Digital tool, Self-guided

Eligibility Criteria

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

Inclusion Criteria:

  • Insomnia complaints of at least medium severity (15 or above on the ISI)
  • Insomnia disorder according to DSM-5
  • Adequate language skills (Swedish)
  • No foreseeable practical hinders to participate
  • Can wear actigraph 24/7
  • Daily access to the internet, via computer, smart phone or tablet

Exclusion Criteria:

  • Sleep disorders requiring other treatment (e.g. sleep apnea)
  • Somatic or psychiatric disorders that require other treatment (e.g. suicide risk, severe depression) or that decrease level of functioning enough to prevent working independently.
  • Use of alcohol or drugs in a way that will affect sleep negatively, use of medications with a negative impact on sleep. (Stable use of anti depressants and stable use or tapering of hypnotics are allowed)
  • Night work or shift work involving night work
  • Ongoing or previous psychological treatment including sleep restricion and stimulus control

Sites / Locations

  • Program for Anxiety and Affective disorders, Stockholm Southwest Psychiatry

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment group

Arm Description

The intervention consists of a self-guided digital tool to guide participants with chronic insomnia through sleep restriction and stimulus control procedures.

Outcomes

Primary Outcome Measures

Insomnia Severity Index
7-item self-reported measure of insomnia severity, 0-28 Points. Higher values represents higher severity (worse outcome)
Insomnia Severity Index
7-item self-reported measure of insomnia severity, 0-28 Points. Higher values represent higher severity (worse outcome)
Treatment acceptability/usefulness
Qualitative quesions regarding participant perception of using the digital tool (ease of use, whether the tool was helpful)

Secondary Outcome Measures

Patient Health Questionnaire (PHQ-9)
9-item self-report measure of depression severity, 0-28 points. Higher values represent higher severity (worse outcome)
Patient Health Questionnaire (PHQ-9)
9-item self-report measure of depression severity, 0-28 points. Higher values represent higher severity (worse outcome)
Generalized Anxiety Disorder Scale (GAD7)
7-item self-report measure of anxiety severity, 0-21 points. Higher values represent higher severity (worse outcome)
Generalized Anxiety Disorder Scale (GAD7)
7-item self-report measure of anxiety severity, 0-21 points. Higher values represent higher severity (worse outcome)

Full Information

First Posted
February 23, 2021
Last Updated
March 29, 2022
Sponsor
Karolinska Institutet
Collaborators
Stockholm Region
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1. Study Identification

Unique Protocol Identification Number
NCT04771234
Brief Title
Digital Psychological Self-care for Sleep Problems
Official Title
Self-guided Digital Psychological Self-care for Individuals With Sleep Problems - Feasibility and Preliminary Effects
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
February 25, 2021 (Actual)
Primary Completion Date
August 30, 2021 (Actual)
Study Completion Date
November 18, 2021 (Actual)

3. Sponsor/Collaborators

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

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
In this non-randomized treatment feasibility pilot we want to explore if a simplified version of CBT-i as a non-therapist-guided digital tool can work; if the digital tool is perceived as user friendly and if participants' insomnia severity is improved following four weeks of treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Insomnia
Keywords
Digital tool, Self-guided

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Treatment group
Arm Type
Experimental
Arm Description
The intervention consists of a self-guided digital tool to guide participants with chronic insomnia through sleep restriction and stimulus control procedures.
Intervention Type
Behavioral
Intervention Name(s)
Digital self-guided CBT-i
Other Intervention Name(s)
Self-care digital tool
Intervention Description
A brief version of CBT-i consisting of brief psychoeducation, and the core components sleep restricion and stimulus control, where sleep restriction is based on a simplified sleep diary.
Primary Outcome Measure Information:
Title
Insomnia Severity Index
Description
7-item self-reported measure of insomnia severity, 0-28 Points. Higher values represents higher severity (worse outcome)
Time Frame
From base-line to 4 weeks
Title
Insomnia Severity Index
Description
7-item self-reported measure of insomnia severity, 0-28 Points. Higher values represent higher severity (worse outcome)
Time Frame
From base-line to 20 weeks
Title
Treatment acceptability/usefulness
Description
Qualitative quesions regarding participant perception of using the digital tool (ease of use, whether the tool was helpful)
Time Frame
From base-line to 4 weeks
Secondary Outcome Measure Information:
Title
Patient Health Questionnaire (PHQ-9)
Description
9-item self-report measure of depression severity, 0-28 points. Higher values represent higher severity (worse outcome)
Time Frame
From base-line to 4 weeks
Title
Patient Health Questionnaire (PHQ-9)
Description
9-item self-report measure of depression severity, 0-28 points. Higher values represent higher severity (worse outcome)
Time Frame
From base-line to 20 weeks
Title
Generalized Anxiety Disorder Scale (GAD7)
Description
7-item self-report measure of anxiety severity, 0-21 points. Higher values represent higher severity (worse outcome)
Time Frame
From base-line to 4 weeks
Title
Generalized Anxiety Disorder Scale (GAD7)
Description
7-item self-report measure of anxiety severity, 0-21 points. Higher values represent higher severity (worse outcome)
Time Frame
From base-line to 20 weeks
Other Pre-specified Outcome Measures:
Title
Adverse events and Negative effects questionnaire (NEQ)
Description
Self-report measures of negative effects and adverse events; Higher values represent more adverse events and negative effects
Time Frame
From base-line to 4 weeks
Title
Actigraphy
Description
A wrist-worn device to measure sleep, giving measures of e.g. total sleep time, wake after sleep onset, and sleep efficiency
Time Frame
From base-line to 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Insomnia complaints of at least medium severity (15 or above on the ISI) Insomnia disorder according to DSM-5 Adequate language skills (Swedish) No foreseeable practical hinders to participate Can wear actigraph 24/7 Daily access to the internet, via computer, smart phone or tablet Exclusion Criteria: Sleep disorders requiring other treatment (e.g. sleep apnea) Somatic or psychiatric disorders that require other treatment (e.g. suicide risk, severe depression) or that decrease level of functioning enough to prevent working independently. Use of alcohol or drugs in a way that will affect sleep negatively, use of medications with a negative impact on sleep. (Stable use of anti depressants and stable use or tapering of hypnotics are allowed) Night work or shift work involving night work Ongoing or previous psychological treatment including sleep restricion and stimulus control
Facility Information:
Facility Name
Program for Anxiety and Affective disorders, Stockholm Southwest Psychiatry
City
Stockholm
ZIP/Postal Code
141 86
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No

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Digital Psychological Self-care for Sleep Problems

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