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

NCT ID: NCT02886052

Last Updated: 2019-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2018-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Insomnia Bereavement

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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ICBT for insomnia

Therapist guided Internet-CBT for insomnia

Group Type EXPERIMENTAL

Therapist guided Internet-CBT for insomnia

Intervention Type BEHAVIORAL

Active control

Written information on sleep, insomnia, and sleep hygiene

Group Type ACTIVE_COMPARATOR

Active control

Intervention Type OTHER

Interventions

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Therapist guided Internet-CBT for insomnia

Intervention Type BEHAVIORAL

Active control

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karolinska Institutet

OTHER

Sponsor Role collaborator

Region Stockholm

OTHER_GOV

Sponsor Role collaborator

Ersta Sköndal University College

OTHER

Sponsor Role lead

Responsible Party

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Josefin Sveen

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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TJ2015-0021

Identifier Type: -

Identifier Source: org_study_id

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