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Completed

NCT Number: NCT05065242

Smartphone-delivered CBT-I

The overall purpose with this investigation was to increase access to cognitive behavioural therapy for insomnia (CBT-I) by examining CBT-I delivered through a smartphone application

The first aim that will be addressed is to explore the efficacy of the smartphone delivered CBT-I on overall insomnia and on nighttime symptoms by comparing CBT-I to a waitlist control in a randomised controlled trial.

The second aim is to investigate the effect smartphone delivered CBT-I compared to the waitlist on secondary outcomes related to insomnia, such as stress, anxiety, depression, quality of life and functional impairment.

The third aim that will be addressed is to examine what patient characteristics that CBT delivered to a smartphone depend on to be effective with a treatment-moderator strategy. To investigate moderators, the following moderators will be assessed; age, gender, occupational status, level of education, initial insomnia severity, dysfunction, medication use, chronic pain, somatic/psychiatric co-morbidity, and proposed behavioral mediators of sleep restriction and stimulus control will also be employed as moderators.

The fourth aim that will be addressed is to examine behavioural processes of sleep restriction and stimulus control as potential mediators of treatment outcome.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska institute

Stockholm, Stockholm County, Sweden

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Presence of insomnia more than three nights per week and for more than three months.
  • Insomnia despite adequate opportunity to sleep.
  • Insomnia severity typical for insomnia disorder, i.e. 11 points or more on the Insomnia Severity Index (ISI).
  • Nighttime insomnia symptoms, i.e., two points or more on at least one of the first three ISI questions.
  • Daytime insomnia symptoms, i.e. two points or more on one or both of the ISI distress and impairment items (numbers 5 and 7).
  • Clinical insomnia symptoms from sleep diaries concerning three nighttime symptoms (difficulties with sleep initiation, difficulties with sleep maintenance, and early morning awakenings), i.e., thirty minutes or more on average on one or more of the symptoms.
  • No current or past CBT-I treatment within the past 5 years.
  • Time and opportunity to participate in treatment for six weeks.
  • Time and opportunity to engage with the treatment content and execute homework assignments for six weeks.
  • Access to a smart mobil telephone, email and internet.

Exclusion criteria

  • Severe depression, i.e., more than 30 points on MADRS-S.
  • Suicidal risk, i.e., 4 points or more on item 9 on MADRS-S.
  • A high intake of alcohol or caffeine,
  • Insomnia due to shiftwork or other sleep-disturbing events (e.g., pregnancy, small children, or animals in the sleep environment).
  • Participants with a history of psychotic or bipolar disorder.
  • If a somatic condition is reported, it is required that it is relatively stable and/or that the candidate is receiving treatment for the condition.
  • When a candidate fulfills criteria for a psychiatric or somatic condition, it is required that insomnia is the disorder currently most distressing and disabling or that the insomnia remains despite treatment for the comorbid condition.
  • Participants with the following primary sleep disorders will be excluded via the Duke Structured Interview for Sleep Disorders (DSISD): sleep apnea, restless legs syndrome, periodic limb movement disorder, circadian rhythm disorder, and parasomnias.
  • If sleep medication is used, it is required that the use has been relatively stable during three months.
  • If Selective Serotonin Reuptake Inhibitors (SSRI) use is reported, it is required that the onset of the medication was at least three months prior to the telephone interview.
  • Participants who regularly consume sleep-disturbing medications.

Treatment and study plan

Cognitive Behavioural Therapy

Behavioral

Sleep restriction, Stimulus control, sleep hygiene and cognitive techniques to handle sleep disturbing thoughts.

Primary outcomes

  1. Insomnia severity index

    Time frame: Pretreatment (week 0), during treatment (i.e., weekly: 1, 2, 3, 4, 5), post-treatment (week 6) and follow-up at 3 month after treatment.

    Global measure of insomnia severity, used for assessing change in insomnia severity from pretreatment to posttreatment.

Secondary outcomes

  1. Work and Social Adjustment Scale

    Time frame: Pretreatment (week 0), post-treatment (week 6) and follow-up at 3 month after treatment

    Score: 0-40, with higher scores indicating worse outcome.

  2. Sleep onset latency (SOL)

    Time frame: Pretreatment (week 0), during treatment (i.e., weekly: 1, 2, 3, 4, 5), post-treatment (week 6).

  3. Wake time after sleep onset (WASO).

    Time frame: Pretreatment (week 0), post-treatment (week 6).

  4. Early morning awakenings (EMA).

    Time frame: Pretreatment (week 0), post-treatment (week 6).

  5. Total sleep time (TST).

    Time frame: Pretreatment (week 0), post-treatment (week 6).

  6. Depression, anxiety and stress scale-21

    Time frame: Pretreatment (week 0), post-treatment (week 6) and follow-up at 3 month after treatment.

    Score: 0-63, with higher scores indicating worse outcome.

  7. Brunnsviken Brief Quality of life index

    Time frame: Pretreatment (week 0), post-treatment (week 6) and follow-up at 3 month after treatment.

    Score: 0-96, with higher scores indicating better quality of life.

  8. Bed and rise time variability

    Time frame: Pretreatment (week 0), during treatment (i.e., weekly: 1, 2, 3, 4, 5), post-treatment (week 6).

  9. Time in bed (TIB)

    Time frame: Pretreatment (week 0), during treatment (i.e., weekly: 1, 2, 3, 4, 5), post-treatment (week 6).

  10. Pre sleep arousal scale

    Time frame: Pretreatment (week 0), during treatment (i.e., weekly: 1, 2, 3, 4, 5), post-treatment (week 6) and follow-up at 3 month after treatment.

    Score: 16-80, with higher scores indicating worse outcome.

Other outcomes

  1. Credibility Expectancy Questionnaire.

    Time frame: During the first treatment module (first week of treatment).

    Score: 4 items, 1-9, 2 items 0-10, with higher scores indicating higher credibility and expectancy.

  2. Client Satisfaction Questionnaire.

    Time frame: Post-treatment (week 6)

    Score: 8-32, with higher scores indicating higher satisfaction.

  3. Activity and adherence with treatment protocol (self developed questionnaire assessing treatment activity and adherence relating to text, homework and therapist support).

    Time frame: Post-treatment (week 6)

    Score ranging from 1-5, with higher scores indicating higher activity and adherence.

  4. three items assessing sick-leave and other concomitant treatment (self developed questionns).

    Time frame: Post-treatment (week 6) and at 3-month follow-up.

    Item one assessing number of days on sick-leave. Item two assessing whether participants have sought other healthcare options. Item three assessing whether participants have received other treatments for their sleeping issues during the specified time frames.

  5. Adverse events (questionnaire from a previous similar study).

    Time frame: Post-treatment (week 6)

  6. Changes in suicide risk (Item 9 from the MADRS).

    Time frame: Pretreatment (week 0), post-treatment (week 10) and follow-up at 6 month after treatment.

    Score: 0-6, with higher scores indicating a higher suicide risk.

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

Smartphone-delivered CBT for Insomnia, a Randomised Controlled Trial

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 4, 2021
Registry last updated
Mar 10, 2023

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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