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Completed

NCT Number: NCT01224912

Internet Delivered Self-Help CBT for Insomnia

The object of this study is to determine variables associated with therapy-success of a cognitive behavioral self help intervention for insomnia. In this study all participants receive an online self-help CBT manual consisting of information (psycho-education) about sleep and cognitive-behavioural exercises. Adult persons with insomnia will be invited via a popular scientific website to fill out online questionnaires. Participants will be measured 4, 16, and 40 weeks after intervention with the same questionnaires.

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Key information

Conditions

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

Phase 3

Primary location

Utrecht University

Utrecht, 3508TC, Netherlands

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Insomnia
  • Access to the internet

Exclusion criteria

  • Alcohol or substance abuse
  • Being suicidal
  • Sleep apnea
  • Schizophrenic or having a psychosis disorder

Treatment and study plan

Cognitive Behavioral Treatment

Behavioral

The techniques used throughout the self-help manual are all effective in reducing insomnia: 1) Stimulus control: patients should only go to bed when sleepy, use the bed and bedroom for sleep (and sex) only, maintain a regular rising time, avoid daytime naps and get out of bed and go into another room when unable to fall asleep within 15-20 minutes (return only when sleepy). 2) progressive muscle relaxation. 3) sleep hygiene education (improving health and environmental factors that affect sleep). 3). Sleep restriction, whereby participants will stay only the time in bed that they sleep. 4) cognitive therapy to challenge and dispute incorrect and unhelpful thoughts about sleep (e.g. I must sleep at least 8 hours, otherwise I'll be a wreck tomorrow).

Primary outcomes

  1. Sleep diary

    Time frame: baseline

    Daily self-observation used to calculate Total Sleep Time, Wake After Sleep Onset, Sleep Onset Latency, Sleep Efficiency, and Day ratings.

  2. Sleep diary

    Time frame: 4-week follow-up

    Daily self-observation used to calculate Total Sleep Time, Wake After Sleep Onset, Sleep Onset Latency, Sleep Efficiency, and Day ratings.

  3. Sleep diary

    Time frame: 18-week follow-up

    Daily self-observation used to calculate Total Sleep Time, Wake After Sleep Onset, Sleep Onset Latency, Sleep Efficiency, and Day ratings.

  4. Sleep diary

    Time frame: 48-week follow-up

    Daily self-observation used to calculate Total Sleep Time, Wake After Sleep Onset, Sleep Onset Latency, Sleep Efficiency, and Day ratings.

Secondary outcomes

  1. Anxiety

    Time frame: Baseline

    Measured with the HADS

  2. Anxiety

    Time frame: 4-week follow-up

    HADS

  3. Anxiety

    Time frame: 18-week follow-up

    HADS

  4. Anxiety

    Time frame: 48-week follow-up

    HADS

  5. Depression

    Time frame: Baseline

    CES-D

  6. Depression

    Time frame: 4 week follow-up

    CES-D

  7. Depression

    Time frame: 18-week follow-up

    CES-D

  8. Depression

    Time frame: 48-week follow-up

    CES-D

  9. Sleep medication

    Time frame: Baseline

    Sleep medication as measured by the sleep diary

  10. Sleep medication

    Time frame: 4-week follow-up

    Sleep medication as measured by the sleep diary

  11. Sleep medication

    Time frame: 18-week follow-up

    Sleep medication as measured by the sleep diary

  12. Sleep medication

    Time frame: 48-week follow-up

    Sleep medication as measured by the sleep diary

  13. Insomnia Severity

    Time frame: Baseline

    Insomnia Severity Index

  14. Insomnia severity

    Time frame: four-week follow-up

    Insomnia Severity Index

  15. Insomnia severity

    Time frame: 18-week follow-up

    Insomnia Severity Index

  16. Insomnia severity

    Time frame: 48-week follow-up

    Insomnia Severity Index

Sponsors and collaborators

Lead sponsor

Utrecht University

Other

Registry information

Official study title

Phase 3 Study of Internet-based Self-help for Insomnia: Factors That Are Associated With Success of the Intervention

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Oct 20, 2010
Registry last updated
Jan 8, 2013

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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