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Completed

NCT Number: NCT01456637

Online Self-Help Intervention for Insomnia: With or Without Feedback

The object of this study is to determine whether feedback added to a self-help protocol for insomnia enhances the treatment effect. In this study all participants receive an online self-help cognitive behavioral therapy (CBT) intervention 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. Half of the participants will received by e-mail from a therapist, the other half of the participants will do the intervention without feedback. 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, 3508YC, Netherlands

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Insomnia
  • Access to internet
  • Dutch citizen

Exclusion criteria

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

Treatment and study plan

CBT for insomnia

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 Sleep Quality.

  2. 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 Sleep Quality.

  3. Diary

    Time frame: 6 month follow-up

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

Secondary outcomes

  1. Insomnia Severity

    Time frame: baseline

    Insomnia Severity Index

  2. Insomnia severity

    Time frame: 4-week follow-up

    Insomnia Severity Index

  3. Insomnia Severity

    Time frame: 6 month follow-up

    Insomnia Severity Index

  4. Anxiety

    Time frame: baseline

    HADS

  5. Anxiety

    Time frame: 4-week follow-up

    HADS

  6. Anxiety

    Time frame: 6-month follow-up

    HADS

  7. Depression

    Time frame: baseline

    CES-D

  8. Depression

    Time frame: 4-week follow-up

    CES-D

  9. Depression

    Time frame: 6-month follow-up

    CES-D

Sponsors and collaborators

Lead sponsor

Utrecht University

Other

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Oct 21, 2011
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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