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

Ersta Sköndal University College0 sites21 target enrollmentSeptember 2016

ConditionsInsomnia Bereavement

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Insomnia
Sponsor: Ersta Sköndal University College
Enrollment: 21
Primary Endpoint: Change (from baseline) in Insomnia Severity Index, ISI
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 2016

End Date

December 31, 2018

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Ersta Sköndal University College

Responsible Party

Principal Investigator

Josefin Sveen

PhD

Ersta Sköndal University College

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change (from baseline) in Insomnia Severity Index, ISI

Time Frame: 0, 9 and 18 months after treatment

7-item, self-rated questionnaire measuring change in insomnia severity.

Secondary Outcomes

Change (from baseline) in Generalised Anxiety Disorder Assessment, GAD-7(0, 9 and 18 months after treatment)
Change (from baseline) in PTSD Checklist for DSM-5 , PCL-5(0, 9 and 18 months after treatment)
Change (from baseline) in Montgomery Asberg Depression Rating Scale, MADRS-S(0, 9 and 18 months after treatment)
Change (from baseline) in Prolonged Grief Disorder, PG-13(0, 9 and 18 months after treatment)
Change (from baseline) in Utrecht Grief Rumination Scale, UGRS(0, 9 and 18 months after treatment)