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Completed

NCT Number: NCT04771234

Digital Psychological Self-care for Sleep Problems

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.

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Key information

Conditions

Chronic Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Program for Anxiety and Affective disorders, Stockholm Southwest Psychiatry

Stockholm, 141 86, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Digital self-guided CBT-i

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.

Other names: Self-care digital tool

Primary outcomes

  1. Insomnia Severity Index

    Time frame: From base-line to 4 weeks

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

  2. Insomnia Severity Index

    Time frame: From base-line to 20 weeks

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

  3. Treatment acceptability/usefulness

    Time frame: From base-line to 4 weeks

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

Secondary outcomes

  1. Patient Health Questionnaire (PHQ-9)

    Time frame: From base-line to 4 weeks

    9-item self-report measure of depression severity, 0-28 points. Higher values represent higher severity (worse outcome)

  2. Patient Health Questionnaire (PHQ-9)

    Time frame: From base-line to 20 weeks

    9-item self-report measure of depression severity, 0-28 points. Higher values represent higher severity (worse outcome)

  3. Generalized Anxiety Disorder Scale (GAD7)

    Time frame: From base-line to 4 weeks

    7-item self-report measure of anxiety severity, 0-21 points. Higher values represent higher severity (worse outcome)

  4. Generalized Anxiety Disorder Scale (GAD7)

    Time frame: From base-line to 20 weeks

    7-item self-report measure of anxiety severity, 0-21 points. Higher values represent higher severity (worse outcome)

Other outcomes

  1. Adverse events and Negative effects questionnaire (NEQ)

    Time frame: From base-line to 4 weeks

    Self-report measures of negative effects and adverse events; Higher values represent more adverse events and negative effects

  2. Actigraphy

    Time frame: From base-line to 4 weeks

    A wrist-worn device to measure sleep, giving measures of e.g. total sleep time, wake after sleep onset, and sleep efficiency

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Region Stockholm

Registry information

Official study title

Self-guided Digital Psychological Self-care for Individuals With Sleep Problems - Feasibility and Preliminary Effects

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 25, 2021
Registry last updated
Mar 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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