Digital Psychological Self-care for Sleep Problems

Chronic Insomnia Clinical Trial

Official title:

Self-guided Digital Psychological Self-care for Individuals With Sleep Problems - Feasibility and Preliminary Effects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04771234
• Other study ID #: 2019-06197
• Status: Completed
• Phase: N/A
• Start date: February 25, 2021
• Est. completion date: November 18, 2021

Study information

• Verified date: March 2022
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 18, 2021
• Est. primary completion date: August 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Insomnia
• Dyssomnias
• Parasomnias
• Sleep Initiation and Maintenance Disorders

Intervention

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.

Locations

Country	Name	City	State
Sweden	Program for Anxiety and Affective disorders, Stockholm Southwest Psychiatry	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Stockholm Region

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse events and Negative effects questionnaire (NEQ)	Self-report measures of negative effects and adverse events; Higher values represent more adverse events and negative effects	From base-line to 4 weeks
Other	Actigraphy	A wrist-worn device to measure sleep, giving measures of e.g. total sleep time, wake after sleep onset, and sleep efficiency	From base-line to 4 weeks
Primary	Insomnia Severity Index	7-item self-reported measure of insomnia severity, 0-28 Points. Higher values represents higher severity (worse outcome)	From base-line to 4 weeks
Primary	Insomnia Severity Index	7-item self-reported measure of insomnia severity, 0-28 Points. Higher values represent higher severity (worse outcome)	From base-line to 20 weeks
Primary	Treatment acceptability/usefulness	Qualitative quesions regarding participant perception of using the digital tool (ease of use, whether the tool was helpful)	From base-line to 4 weeks
Secondary	Patient Health Questionnaire (PHQ-9)	9-item self-report measure of depression severity, 0-28 points. Higher values represent higher severity (worse outcome)	From base-line to 4 weeks
Secondary	Patient Health Questionnaire (PHQ-9)	9-item self-report measure of depression severity, 0-28 points. Higher values represent higher severity (worse outcome)	From base-line to 20 weeks
Secondary	Generalized Anxiety Disorder Scale (GAD7)	7-item self-report measure of anxiety severity, 0-21 points. Higher values represent higher severity (worse outcome)	From base-line to 4 weeks
Secondary	Generalized Anxiety Disorder Scale (GAD7)	7-item self-report measure of anxiety severity, 0-21 points. Higher values represent higher severity (worse outcome)	From base-line to 20 weeks