Digital Psychological Self-care for Sleep Problems

Not Applicable

Completed

• Conditions: Chronic Insomnia
• Interventions: Behavioral: Digital self-guided CBT-i

• Registration Number: NCT04771234
• Lead Sponsor: 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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2021-02-23
• Study First Submitted QC: 2021-02-23
• Study Start: 2021-02-25
• Study First Posted: 2021-02-25
• Primary Completion: 2021-08-30
• Study Completion: 2021-11-18
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-29
• Last Update Posted: 2022-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment group	Digital self-guided CBT-i	The intervention consists of a self-guided digital tool to guide participants with chronic insomnia through sleep restriction and stimulus control procedures.

Primary Outcome Measures

Name	Time	Method
Treatment acceptability/usefulness	From base-line to 4 weeks	Qualitative quesions regarding participant perception of using the digital tool (ease of use, whether the tool was helpful)
Insomnia Severity Index	From base-line to 20 weeks	7-item self-reported measure of insomnia severity, 0-28 Points. Higher values represent higher severity (worse outcome)

Secondary Outcome Measures

Name	Time	Method
Patient Health Questionnaire (PHQ-9)	From base-line to 20 weeks	9-item self-report measure of depression severity, 0-28 points. Higher values represent higher severity (worse outcome)
Generalized Anxiety Disorder Scale (GAD7)	From base-line to 20 weeks	7-item self-report measure of anxiety severity, 0-21 points. Higher values represent higher severity (worse outcome)

Trial Locations

Locations (1)

Program for Anxiety and Affective disorders, Stockholm Southwest Psychiatry; 🇸🇪 Stockholm, Sweden