NCT04771234

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

February 23, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 25, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

February 25, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 18, 2021

Completed
Last Updated

March 31, 2022

Status Verified

March 1, 2022

Enrollment Period

6 months

First QC Date

February 23, 2021

Last Update Submit

March 29, 2022

Conditions

Chronic Insomnia

Keywords

Digital toolSelf-guided

Outcome Measures

Primary Outcomes (3)

  • Insomnia Severity Index

    7-item self-reported measure of insomnia severity, 0-28 Points. Higher values represents higher severity (worse outcome)

    From base-line to 4 weeks

  • Insomnia Severity Index

    7-item self-reported measure of insomnia severity, 0-28 Points. Higher values represent higher severity (worse outcome)

    From base-line to 20 weeks

  • Treatment acceptability/usefulness

    Qualitative quesions regarding participant perception of using the digital tool (ease of use, whether the tool was helpful)

    From base-line to 4 weeks

Secondary Outcomes (4)

  • Patient Health Questionnaire (PHQ-9)

    From base-line to 4 weeks

  • Patient Health Questionnaire (PHQ-9)

    From base-line to 20 weeks

  • Generalized Anxiety Disorder Scale (GAD7)

    From base-line to 4 weeks

  • Generalized Anxiety Disorder Scale (GAD7)

    From base-line to 20 weeks

Other Outcomes (2)

  • Adverse events and Negative effects questionnaire (NEQ)

    From base-line to 4 weeks

  • Actigraphy

    From base-line to 4 weeks

Study Arms (1)

Treatment group

EXPERIMENTAL

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

Behavioral: Digital self-guided CBT-i

Interventions

Digital self-guided CBT-iBEHAVIORAL

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.

Also known as: Self-care digital tool
Treatment group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Program for Anxiety and Affective disorders, Stockholm Southwest Psychiatry

Stockholm, 141 86, Sweden

Location

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
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single Group Assignment Pragmatic, within-group pilot study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

February 23, 2021

First Posted

February 25, 2021

Study Start

February 25, 2021

Primary Completion

August 30, 2021

Study Completion

November 18, 2021

Last Updated

March 31, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)