Digital Psychological Self-care for Sleep Problems

NCT ID: NCT04771234

Last Updated: 2022-03-31

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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-25

Study Completion Date

2021-11-18

Brief Summary

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In this non-randomized treatment feasibility pilot we want to explore if a simplified version of CBT-i as a non-therapist-guided digital tool can work; if the digital tool is perceived as user friendly and if participants' insomnia severity is improved following four weeks of treatment.

Detailed Description

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Conditions

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Chronic Insomnia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single Group Assignment Pragmatic, within-group pilot study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment group

The intervention consists of a self-guided digital tool to guide participants with chronic insomnia through sleep restriction and stimulus control procedures.

Group Type EXPERIMENTAL

Digital self-guided CBT-i

Intervention Type BEHAVIORAL

A brief version of CBT-i consisting of brief psychoeducation, and the core components sleep restricion and stimulus control, where sleep restriction is based on a simplified sleep diary.

Interventions

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Digital self-guided CBT-i

A brief version of CBT-i consisting of brief psychoeducation, and the core components sleep restricion and stimulus control, where sleep restriction is based on a simplified sleep diary.

Intervention Type BEHAVIORAL

Other Intervention Names

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Self-care digital tool

Eligibility Criteria

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Inclusion Criteria

* Insomnia complaints of at least medium severity (15 or above on the ISI)
* Insomnia disorder according to DSM-5
* Adequate language skills (Swedish)
* No foreseeable practical hinders to participate
* Can wear actigraph 24/7
* Daily access to the internet, via computer, smart phone or tablet

Exclusion Criteria

* Sleep disorders requiring other treatment (e.g. sleep apnea)
* Somatic or psychiatric disorders that require other treatment (e.g. suicide risk, severe depression) or that decrease level of functioning enough to prevent working independently.
* Use of alcohol or drugs in a way that will affect sleep negatively, use of medications with a negative impact on sleep. (Stable use of anti depressants and stable use or tapering of hypnotics are allowed)
* Night work or shift work involving night work
* Ongoing or previous psychological treatment including sleep restricion and stimulus control
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Region Stockholm

OTHER_GOV

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Susanna Jernelöv

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Program for Anxiety and Affective disorders, Stockholm Southwest Psychiatry

Stockholm, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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2019-06197

Identifier Type: -

Identifier Source: org_study_id

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