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| Name | Class |
|---|---|
| Karolinska Institutet | OTHER |
| Region Stockholm | OTHER_GOV |
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The purpose of this project is to evaluate an Internet-based Cognitive Behavioral Therapy (ICBT) for bereaved parents with insomnia. Participants are randomized to either a therapist guided ICBT or to an active control who receives written information on sleep, insomnia, and sleep hygiene. The primary purpose is to evaluate changes in insomnia severity for treatment compared control, after treatment and at 9 and 18 months follow up. A secondary purpose is to evaluate changes in symptoms of complicated grief and depression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICBT for insomnia | Experimental | Therapist guided Internet-CBT for insomnia |
|
| Active control | Active Comparator | Written information on sleep, insomnia, and sleep hygiene |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Therapist guided Internet-CBT for insomnia | Behavioral |
| ||
| Active control |
| Measure | Description | Time Frame |
|---|---|---|
| Change (from baseline) in Insomnia Severity Index, ISI | 7-item, self-rated questionnaire measuring change in insomnia severity. | 0, 9 and 18 months after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change (from baseline) in Montgomery Asberg Depression Rating Scale, MADRS-S | The MADRS-S is a 9-item self-rated measure of change in depression severity. | 0, 9 and 18 months after treatment |
| Change (from baseline) in Prolonged Grief Disorder, PG-13 |
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Inclusion Criteria:
Exclusion Criteria:
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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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| Other |
|
13-item, self-rated measure of prolonged grief disorder
| 0, 9 and 18 months after treatment |
| Change (from baseline) in PTSD Checklist for DSM-5 , PCL-5 | 20-item, self-rated measure of posttraumatic stress disorder | 0, 9 and 18 months after treatment |
| Change (from baseline) in Generalised Anxiety Disorder Assessment, GAD-7 | 7-item, self-rated measure of anxiety symptoms | 0, 9 and 18 months after treatment |
| Change (from baseline) in Utrecht Grief Rumination Scale, UGRS | 15-item, self-rated measure of grief rumination | 0, 9 and 18 months after treatment |
| D001523 |
| Mental Disorders |