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Digital Psychological Self-care for Sleep Problems

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ClinicalTrials.gov Identifier: NCT04771234
Recruitment Status : Active, not recruiting
First Posted : February 25, 2021
Last Update Posted : May 19, 2021
Sponsor:
Collaborator:
Stockholm Region
Information provided by (Responsible Party):
Susanna Jernelöv, Karolinska Institutet

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.

Condition or disease Intervention/treatment Phase
Chronic Insomnia Behavioral: Digital self-guided CBT-i Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single Group Assignment Pragmatic, within-group pilot study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Self-guided Digital Psychological Self-care for Individuals With Sleep Problems - Feasibility and Preliminary Effects
Actual Study Start Date : February 25, 2021
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : November 2021

Arm Intervention/treatment
Experimental: Treatment group
The intervention consists of a self-guided digital tool to guide participants with chronic insomnia through sleep restriction and stimulus control procedures.
Behavioral: Digital self-guided CBT-i
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.
Other Name: Self-care digital tool




Primary Outcome Measures :
  1. Insomnia Severity Index [ Time Frame: From base-line to 4 weeks ]
    7-item self-reported measure of insomnia severity, 0-28 Points. Higher values represents higher severity (worse outcome)

  2. Insomnia Severity Index [ Time Frame: From base-line to 20 weeks ]
    7-item self-reported measure of insomnia severity, 0-28 Points. Higher values represent higher severity (worse outcome)

  3. Treatment acceptability/usefulness [ Time Frame: From base-line to 4 weeks ]
    Qualitative quesions regarding participant perception of using the digital tool (ease of use, whether the tool was helpful)


Secondary Outcome Measures :
  1. Patient Health Questionnaire (PHQ-9) [ Time Frame: From base-line to 4 weeks ]
    9-item self-report measure of depression severity, 0-28 points. Higher values represent higher severity (worse outcome)

  2. Patient Health Questionnaire (PHQ-9) [ Time Frame: From base-line to 20 weeks ]
    9-item self-report measure of depression severity, 0-28 points. Higher values represent higher severity (worse outcome)

  3. Generalized Anxiety Disorder Scale (GAD7) [ Time Frame: From base-line to 4 weeks ]
    7-item self-report measure of anxiety severity, 0-21 points. Higher values represent higher severity (worse outcome)

  4. Generalized Anxiety Disorder Scale (GAD7) [ Time Frame: From base-line to 20 weeks ]
    7-item self-report measure of anxiety severity, 0-21 points. Higher values represent higher severity (worse outcome)


Other Outcome Measures:
  1. Adverse events and Negative effects questionnaire (NEQ) [ Time Frame: From base-line to 4 weeks ]
    Self-report measures of negative effects and adverse events; Higher values represent more adverse events and negative effects

  2. Actigraphy [ Time Frame: From base-line to 4 weeks ]
    A wrist-worn device to measure sleep, giving measures of e.g. total sleep time, wake after sleep onset, and sleep efficiency



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04771234


Locations
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Sweden
Program for Anxiety and Affective disorders, Stockholm Southwest Psychiatry
Stockholm, Sweden, 141 86
Sponsors and Collaborators
Karolinska Institutet
Stockholm Region
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Responsible Party: Susanna Jernelöv, Associate professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT04771234    
Other Study ID Numbers: 2019-06197
First Posted: February 25, 2021    Key Record Dates
Last Update Posted: May 19, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Susanna Jernelöv, Karolinska Institutet:
Digital tool
Self-guided
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Dyssomnias
Parasomnias
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders