Internet Delivered Self-Help CBT for Insomnia

This study has been completed.
Sponsor:
Information provided by:
Utrecht University
ClinicalTrials.gov Identifier:
NCT01224912
First received: October 18, 2010
Last updated: January 7, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Insomnia
Behavioral: Cognitive Behavioral Treatment
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 3 Study of Internet-based Self-help for Insomnia: Factors That Are Associated With Success of the Intervention

Resource links provided by NLM:


Further study details as provided by Utrecht University:

Primary Outcome Measures:
  • 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 Day ratings.

  • Sleep 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 Day ratings.

  • Sleep diary [ Time Frame: 18-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 Day ratings.

  • Sleep diary [ Time Frame: 48-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 Day ratings.


Secondary Outcome Measures:
  • Anxiety [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Measured with the HADS

  • Anxiety [ Time Frame: 4-week follow-up ] [ Designated as safety issue: No ]
    HADS

  • Anxiety [ Time Frame: 18-week follow-up ] [ Designated as safety issue: No ]
    HADS

  • Anxiety [ Time Frame: 48-week 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: 18-week follow-up ] [ Designated as safety issue: No ]
    CES-D

  • Depression [ Time Frame: 48-week follow-up ] [ Designated as safety issue: No ]
    CES-D

  • Sleep medication [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Sleep medication as measured by the sleep diary

  • Sleep medication [ Time Frame: 4-week follow-up ] [ Designated as safety issue: No ]
    Sleep medication as measured by the sleep diary

  • Sleep medication [ Time Frame: 18-week follow-up ] [ Designated as safety issue: No ]
    Sleep medication as measured by the sleep diary

  • Sleep medication [ Time Frame: 48-week follow-up ] [ Designated as safety issue: No ]
    Sleep medication as measured by the sleep diary

  • Insomnia Severity [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Insomnia Severity Index

  • Insomnia severity [ Time Frame: four-week follow-up ] [ Designated as safety issue: No ]
    Insomnia Severity Index

  • Insomnia severity [ Time Frame: 18-week follow-up ] [ Designated as safety issue: No ]
    Insomnia Severity Index

  • Insomnia severity [ Time Frame: 48-week follow-up ] [ Designated as safety issue: No ]
    Insomnia Severity Index


Enrollment: 479
Study Start Date: October 2010
Study Completion Date: October 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Internet Deliviered CBT for Insomnia
Cognitive behavioral self-help method for insomnia via the Internet
Behavioral: Cognitive Behavioral Treatment
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Insomnia
  • Access to the internet

Exclusion Criteria:

  • Alcohol or substance abuse
  • Being suicidal
  • Sleep apnea
  • Schizophrenic or having a psychosis disorder
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01224912

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

Additional Information:
No publications provided

Responsible Party: Utrecht University
ClinicalTrials.gov Identifier: NCT01224912     History of Changes
Other Study ID Numbers: UU-vandenBout-2
Study First Received: October 18, 2010
Last Updated: January 7, 2013
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

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

ClinicalTrials.gov processed this record on September 16, 2014