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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01456637
First Posted: October 21, 2011
Last Update Posted: January 8, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Utrecht University
  Purpose
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.

Condition Intervention Phase
Insomnia Behavioral: CBT for insomnia Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Online Self-Help Intervention for Insomnia: With or Without Feedback

Further study details as provided by Utrecht University:

Primary Outcome Measures:
  • 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.

  • 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.

  • 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 Outcome Measures:
  • Insomnia Severity [ Time Frame: baseline ]
    Insomnia Severity Index

  • Insomnia severity [ Time Frame: 4-week follow-up ]
    Insomnia Severity Index

  • Insomnia Severity [ Time Frame: 6 month follow-up ]
    Insomnia Severity Index

  • Anxiety [ Time Frame: baseline ]
    HADS

  • Anxiety [ Time Frame: 4-week follow-up ]
    HADS

  • Anxiety [ Time Frame: 6-month follow-up ]
    HADS

  • Depression [ Time Frame: baseline ]
    CES-D

  • Depression [ Time Frame: 4-week follow-up ]
    CES-D

  • Depression [ Time Frame: 6-month follow-up ]
    CES-D


Enrollment: 262
Study Start Date: October 2011
Study Completion Date: December 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CBT for insomnia with feedback
In this arm participants received internet based self-help CBT for insomnia with e-mail feedback form a therapist.
Behavioral: CBT for insomnia
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).
Experimental: CBT for insomnia without feedback
In this arm participants receive internet based self-help CBT for insomnia without feedback from a therapist.
Behavioral: CBT for insomnia
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).

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Insomnia
  • Access to internet
  • Dutch citizen

Exclusion Criteria:

  • Alcohol or substance abuse
  • Being suicidal
  • Sleep apnea
  • Schizophrenic or having a psychosis disorder
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01456637


Locations
Netherlands
Utrecht University
Utrecht, Netherlands, 3508YC
Sponsors and Collaborators
Utrecht University
Investigators
Principal Investigator: Jaap Lancee, PhD Utrecht University
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT01456637     History of Changes
Other Study ID Numbers: FPG-20106524
First Submitted: October 20, 2011
First Posted: October 21, 2011
Last Update Posted: January 8, 2013
Last Verified: January 2013

Keywords provided by Utrecht University:
Insomnia
Intervention
Self-help
Internet

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders