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

Primary Purpose

Insomnia, Bereavement

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Therapist guided Internet-CBT for insomnia
Active control
Sponsored by
Ersta Sköndal University College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia focused on measuring Cognitive behavior therapy, Internet treatment, Self-help treatment, Insomnia, ICBT, CBT-i, Bereavement

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    ICBT for insomnia

    Active control

    Arm Description

    Therapist guided Internet-CBT for insomnia

    Written information on sleep, insomnia, and sleep hygiene

    Outcomes

    Primary Outcome Measures

    Change (from baseline) in Insomnia Severity Index, ISI
    7-item, self-rated questionnaire measuring change in insomnia severity.

    Secondary Outcome Measures

    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.
    Change (from baseline) in Prolonged Grief Disorder, PG-13
    13-item, self-rated measure of prolonged grief disorder
    Change (from baseline) in PTSD Checklist for DSM-5 , PCL-5
    20-item, self-rated measure of posttraumatic stress disorder
    Change (from baseline) in Generalised Anxiety Disorder Assessment, GAD-7
    7-item, self-rated measure of anxiety symptoms
    Change (from baseline) in Utrecht Grief Rumination Scale, UGRS
    15-item, self-rated measure of grief rumination

    Full Information

    First Posted
    August 15, 2016
    Last Updated
    April 12, 2019
    Sponsor
    Ersta Sköndal University College
    Collaborators
    Karolinska Institutet, Region Stockholm
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02886052
    Brief Title
    Internet-based Cognitive Behavior Therapy for Insomnia for Parents Who Have Lost a Child
    Official Title
    Therapist Guided Internet Cognitive Behavioral Therapy (ICBT) for Insomnia for Bereaved Parents: a Randomized Controlled Trial (RCT)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2016 (undefined)
    Primary Completion Date
    June 2018 (Actual)
    Study Completion Date
    December 31, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ersta Sköndal University College
    Collaborators
    Karolinska Institutet, Region Stockholm

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Insomnia, Bereavement
    Keywords
    Cognitive behavior therapy, Internet treatment, Self-help treatment, Insomnia, ICBT, CBT-i, Bereavement

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    21 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    ICBT for insomnia
    Arm Type
    Experimental
    Arm Description
    Therapist guided Internet-CBT for insomnia
    Arm Title
    Active control
    Arm Type
    Active Comparator
    Arm Description
    Written information on sleep, insomnia, and sleep hygiene
    Intervention Type
    Behavioral
    Intervention Name(s)
    Therapist guided Internet-CBT for insomnia
    Intervention Type
    Other
    Intervention Name(s)
    Active control
    Primary Outcome Measure Information:
    Title
    Change (from baseline) in Insomnia Severity Index, ISI
    Description
    7-item, self-rated questionnaire measuring change in insomnia severity.
    Time Frame
    0, 9 and 18 months after treatment
    Secondary Outcome Measure Information:
    Title
    Change (from baseline) in Montgomery Asberg Depression Rating Scale, MADRS-S
    Description
    The MADRS-S is a 9-item self-rated measure of change in depression severity.
    Time Frame
    0, 9 and 18 months after treatment
    Title
    Change (from baseline) in Prolonged Grief Disorder, PG-13
    Description
    13-item, self-rated measure of prolonged grief disorder
    Time Frame
    0, 9 and 18 months after treatment
    Title
    Change (from baseline) in PTSD Checklist for DSM-5 , PCL-5
    Description
    20-item, self-rated measure of posttraumatic stress disorder
    Time Frame
    0, 9 and 18 months after treatment
    Title
    Change (from baseline) in Generalised Anxiety Disorder Assessment, GAD-7
    Description
    7-item, self-rated measure of anxiety symptoms
    Time Frame
    0, 9 and 18 months after treatment
    Title
    Change (from baseline) in Utrecht Grief Rumination Scale, UGRS
    Description
    15-item, self-rated measure of grief rumination
    Time Frame
    0, 9 and 18 months after treatment

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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