Trial record 7 of 693 for:    insomnia

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
  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: Open Label
Primary Purpose: Treatment
Official Title: Online Self-Help Intervention for Insomnia: With or Without Feedback

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 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.


Secondary Outcome Measures:
  • 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


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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: 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:
No publications provided

ClinicalTrials.gov Identifier: NCT01456637     History of Changes
Other Study ID Numbers: FPG-20106524
Study First Received: October 20, 2011
Last Updated: January 7, 2013
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

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

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

ClinicalTrials.gov processed this record on July 31, 2014