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

Insomnia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02886052
• Other study ID #: TJ2015-0021
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: December 31, 2018

Study information

• Verified date: April 2019
• Source: Ersta Sköndal University College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: December 31, 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Bereavement
• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• Therapist guided Internet-CBT for insomnia

Other:
• Active control

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Ersta Sköndal University College	Karolinska Institutet, Stockholm County Council, Sweden

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change (from baseline) in Utrecht Grief Rumination Scale, UGRS	15-item, self-rated measure of grief rumination	0, 9 and 18 months after treatment