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

April 12, 2019 updated by: Josefin Sveen, Ersta Sköndal University College

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
Time Frame: 0, 9 and 18 months after treatment
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
Time Frame: 0, 9 and 18 months after treatment
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
Time Frame: 0, 9 and 18 months after treatment
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
Time Frame: 0, 9 and 18 months after treatment
7-item, self-rated measure of anxiety symptoms
0, 9 and 18 months after treatment
Change (from baseline) in Utrecht Grief Rumination Scale, UGRS
Time Frame: 0, 9 and 18 months after treatment
15-item, self-rated measure of grief rumination
0, 9 and 18 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ersta Sköndal University College

Collaborators

Karolinska Institutet
Region Stockholm

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Actual)

June 1, 2018

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

August 15, 2016

First Submitted That Met QC Criteria

August 28, 2016

First Posted (Estimate)

September 1, 2016

Study Record Updates

Last Update Posted (Actual)

April 16, 2019

Last Update Submitted That Met QC Criteria

April 12, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TJ2015-0021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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