Internet-based Cognitive Behavior Therapy for Insomnia for Parents Who Have Lost a Child

Study Overview
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Brief Summary
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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.

Official Title
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Therapist Guided Internet Cognitive Behavioral Therapy (ICBT) for Insomnia for Bereaved Parents: a Randomized Controlled Trial (RCT)

Conditions
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Insomnia, Bereavement

Intervention / Treatment
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* Behavioral: Therapist guided Internet-CBT for insomnia
* Other: Active control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical level of Insomnia (more than 10 on ISI) Meets criteria for Insomnia according to DSM-5 Enough Swedish language skills Exclusion Criteria: Other sleep disorders that require other treatment (e.g. sleep apnea) Somatic or psychiatric conditions requiring acute care
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ICBT for insomnia<br>Therapist guided Internet-CBT for insomnia | Behavioral: Therapist guided Internet-CBT for insomnia<br> <br> |
| Active Comparator: Active control<br>Written information on sleep, insomnia, and sleep hygiene | Other: Active control<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognitive behavior therapy, Internet treatment, Self-help treatment, Insomnia, ICBT, CBT-i, Bereavement