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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02886052
Other study ID # TJ2015-0021
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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