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| Name | Class |
|---|---|
| Region Stockholm | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental | The intervention consists of a self-guided digital tool to guide participants with chronic insomnia through sleep restriction and stimulus control procedures. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital self-guided CBT-i | Behavioral | 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. |
| 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 |
| 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) |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Program for Anxiety and Affective disorders, Stockholm Southwest Psychiatry | Stockholm | 141 86 | Sweden |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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Single Group Assignment Pragmatic, within-group pilot study
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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 |
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 |
| D001523 |
| Mental Disorders |