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

Not Applicable

Completed

• Conditions: Insomnia; Bereavement
• Interventions: Other: Active control; Behavioral: Therapist guided Internet-CBT for insomnia

• Registration Number: NCT02886052
• Lead Sponsor: Ersta Sköndal University College

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-08-15
• Study First Submitted QC: 2016-08-28
• Study Start: 2016-09
• Study First Posted: 2016-09-01
• Primary Completion: 2018-06
• Study Completion: 2018-12-31
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-12
• Last Update Posted: 2019-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active control	Active control	Written information on sleep, insomnia, and sleep hygiene
ICBT for insomnia	Therapist guided Internet-CBT for insomnia	Therapist guided Internet-CBT for insomnia

Primary Outcome Measures

Name	Time	Method
Change (from baseline) in Insomnia Severity Index, ISI	0, 9 and 18 months after treatment	7-item, self-rated questionnaire measuring change in insomnia severity.

Secondary Outcome Measures

Name	Time	Method
Change (from baseline) in Generalised Anxiety Disorder Assessment, GAD-7	0, 9 and 18 months after treatment	7-item, self-rated measure of anxiety symptoms
Change (from baseline) in PTSD Checklist for DSM-5 , PCL-5	0, 9 and 18 months after treatment	20-item, self-rated measure of posttraumatic stress disorder
Change (from baseline) in Montgomery Asberg Depression Rating Scale, MADRS-S	0, 9 and 18 months after treatment	The MADRS-S is a 9-item self-rated measure of change in depression severity.
Change (from baseline) in Prolonged Grief Disorder, PG-13	0, 9 and 18 months after treatment	13-item, self-rated measure of prolonged grief disorder
Change (from baseline) in Utrecht Grief Rumination Scale, UGRS	0, 9 and 18 months after treatment	15-item, self-rated measure of grief rumination