Digital Psychological Self-care for Sleep Problems

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Insomnia
• Intervention / Treatment: Behavioral: Digital self-guided CBT-i

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 141 86
    • Program for Anxiety and Affective disorders, Stockholm Southwest Psychiatry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: Self-care digital tool

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Stockholm Region

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2021
• Primary Completion (Actual): August 30, 2021
• Study Completion (Actual): November 18, 2021

Study Registration Dates

• First Submitted: February 23, 2021
• First Submitted That Met QC Criteria: February 23, 2021
• First Posted (Actual): February 25, 2021

Study Record Updates

• Last Update Posted (Actual): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 29, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Self-guided; Digital tool
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders; Dyssomnias; Parasomnias
• Other Study ID Numbers: 2019-06197

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No