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

This study has been completed.
Sponsor:
Information provided by:
Utrecht University
ClinicalTrials.gov Identifier:
NCT01456637
First received: October 20, 2011
Last updated: January 7, 2013
Last verified: January 2013

October 20, 2011
January 7, 2013
October 2011
May 2012   (final data collection date for primary outcome measure)
  • Sleep diary [ Time Frame: baseline ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Daily self-observation used to calculate Total Sleep Time, Wake After Sleep Onset, Sleep Onset Latency, Sleep Efficiency, and Sleep Quality.
Same as current
Complete list of historical versions of study NCT01456637 on ClinicalTrials.gov Archive Site
  • Insomnia Severity [ Time Frame: baseline ] [ Designated as safety issue: No ]
    Insomnia Severity Index
  • Insomnia severity [ Time Frame: 4-week follow-up ] [ Designated as safety issue: No ]
    Insomnia Severity Index
  • Insomnia Severity [ Time Frame: 6 month follow-up ] [ Designated as safety issue: No ]
    Insomnia Severity Index
  • Anxiety [ Time Frame: baseline ] [ Designated as safety issue: No ]
    HADS
  • Anxiety [ Time Frame: 4-week follow-up ] [ Designated as safety issue: No ]
    HADS
  • Anxiety [ Time Frame: 6-month follow-up ] [ Designated as safety issue: No ]
    HADS
  • Depression [ Time Frame: baseline ] [ Designated as safety issue: No ]
    CES-D
  • Depression [ Time Frame: 4-week follow-up ] [ Designated as safety issue: No ]
    CES-D
  • Depression [ Time Frame: 6-month follow-up ] [ Designated as safety issue: No ]
    CES-D
Same as current
Not Provided
Not Provided
 
Online Self-Help Intervention for Insomnia: With or Without Feedback
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Insomnia
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 with feedback
    In this arm participants received internet based self-help CBT for insomnia with e-mail feedback form a therapist.
    Intervention: Behavioral: CBT for insomnia
  • Experimental: CBT for insomnia without feedback
    In this arm participants receive internet based self-help CBT for insomnia without feedback from a therapist.
    Intervention: Behavioral: CBT for insomnia
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
262
December 2012
May 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Insomnia
  • Access to internet
  • Dutch citizen

Exclusion Criteria:

  • Alcohol or substance abuse
  • Being suicidal
  • Sleep apnea
  • Schizophrenic or having a psychosis disorder
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01456637
FPG-20106524
Yes
Not Provided
Utrecht University
Not Provided
Principal Investigator: Jaap Lancee, PhD Utrecht University
Utrecht University
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP