NCT02886052

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2016

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 15, 2016

Completed
17 days until next milestone

First Posted

Study publicly available on registry

September 1, 2016

Completed
Same day until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

April 16, 2019

Status Verified

April 1, 2019

Enrollment Period

1.7 years

First QC Date

August 15, 2016

Last Update Submit

April 12, 2019

Conditions

InsomniaBereavement

Keywords

Cognitive behavior therapyInternet treatmentSelf-help treatmentInsomniaICBTCBT-iBereavement

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Change (from baseline) in Montgomery Asberg Depression Rating Scale, MADRS-S

    0, 9 and 18 months after treatment

  • Change (from baseline) in Prolonged Grief Disorder, PG-13

    0, 9 and 18 months after treatment

  • Change (from baseline) in PTSD Checklist for DSM-5 , PCL-5

    0, 9 and 18 months after treatment

  • Change (from baseline) in Generalised Anxiety Disorder Assessment, GAD-7

    0, 9 and 18 months after treatment

  • Change (from baseline) in Utrecht Grief Rumination Scale, UGRS

    0, 9 and 18 months after treatment

Study Arms (2)

ICBT for insomnia

EXPERIMENTAL

Therapist guided Internet-CBT for insomnia

Behavioral: Therapist guided Internet-CBT for insomnia

Active control

ACTIVE COMPARATOR

Written information on sleep, insomnia, and sleep hygiene

Other: Active control

Interventions

Therapist guided Internet-CBT for insomniaBEHAVIORAL
ICBT for insomnia
Active controlOTHER
Active control

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical level of Insomnia (more than 10 on ISI)
  • Meets criteria for Insomnia according to DSM-5
  • Enough Swedish language skills

You may not qualify if:

  • Other sleep disorders that require other treatment (e.g. sleep apnea)
  • Somatic or psychiatric conditions requiring acute care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

August 15, 2016

First Posted

September 1, 2016

Study Start

September 1, 2016

Primary Completion

June 1, 2018

Study Completion

December 31, 2018

Last Updated

April 16, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share