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Completed

NCT Number: NCT02886052

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

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.

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Key information

Conditions

Insomnia Bereavement Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Therapist guided Internet-CBT for insomnia

Behavioral

Active Control

Other

Primary outcomes

  1. 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

  1. 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.

  2. 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

  3. 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

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

Ersta Sköndal University College

Other

Collaborators

  • Karolinska Institutet
  • Region Stockholm

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Sep 1, 2016
Registry last updated
Apr 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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