Chronic Insomnia
Conditions
Keywords
Digital tool, Self-guided
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.
Interventions
BEHAVIORALDigital 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.
Sponsors
Region Stockholm
Karolinska Institutet
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single Group Assignment Pragmatic, within-group pilot study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Insomnia Severity Index | From base-line to 4 weeks | 7-item self-reported measure of insomnia severity, 0-28 Points. Higher values represents higher severity (worse outcome) |
| 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Health Questionnaire (PHQ-9) | From base-line to 4 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 4 weeks | 7-item self-report measure of anxiety severity, 0-21 points. Higher values represent higher severity (worse outcome) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse events and Negative effects questionnaire (NEQ) | From base-line to 4 weeks | Self-report measures of negative effects and adverse events; Higher values represent more adverse events and negative effects |
| Actigraphy | 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 |
Countries
Sweden
Outcome results
None listed