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Internet Delivered Self-Help CBT for Insomnia

Primary Purpose

Insomnia

Status
Completed
Phase
Phase 3
Locations
Netherlands
Study Type
Interventional
Intervention
Cognitive Behavioral Treatment
Sponsored by
Utrecht University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia focused on measuring Insomnia, Intervention, Self-help, Internet

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Insomnia
  • Access to the internet

Exclusion Criteria:

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

Sites / Locations

  • Utrecht University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Internet Deliviered CBT for Insomnia

Arm Description

Cognitive behavioral self-help method for insomnia via the Internet

Outcomes

Primary Outcome Measures

Sleep diary
Daily self-observation used to calculate Total Sleep Time, Wake After Sleep Onset, Sleep Onset Latency, Sleep Efficiency, and Day ratings.
Sleep diary
Daily self-observation used to calculate Total Sleep Time, Wake After Sleep Onset, Sleep Onset Latency, Sleep Efficiency, and Day ratings.
Sleep diary
Daily self-observation used to calculate Total Sleep Time, Wake After Sleep Onset, Sleep Onset Latency, Sleep Efficiency, and Day ratings.
Sleep diary
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
Measured with the HADS
Anxiety
HADS
Anxiety
HADS
Anxiety
HADS
Depression
CES-D
Depression
CES-D
Depression
CES-D
Depression
CES-D
Sleep medication
Sleep medication as measured by the sleep diary
Sleep medication
Sleep medication as measured by the sleep diary
Sleep medication
Sleep medication as measured by the sleep diary
Sleep medication
Sleep medication as measured by the sleep diary
Insomnia Severity
Insomnia Severity Index
Insomnia severity
Insomnia Severity Index
Insomnia severity
Insomnia Severity Index
Insomnia severity
Insomnia Severity Index

Full Information

First Posted
October 18, 2010
Last Updated
January 7, 2013
Sponsor
Utrecht University
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1. Study Identification

Unique Protocol Identification Number
NCT01224912
Brief Title
Internet Delivered Self-Help CBT for Insomnia
Official Title
Phase 3 Study of Internet-based Self-help for Insomnia: Factors That Are Associated With Success of the Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Utrecht University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia
Keywords
Insomnia, Intervention, Self-help, Internet

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
479 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Internet Deliviered CBT for Insomnia
Arm Type
Experimental
Arm Description
Cognitive behavioral self-help method for insomnia via the Internet
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Treatment
Intervention Description
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 Outcome Measure Information:
Title
Sleep diary
Description
Daily self-observation used to calculate Total Sleep Time, Wake After Sleep Onset, Sleep Onset Latency, Sleep Efficiency, and Day ratings.
Time Frame
baseline
Title
Sleep diary
Description
Daily self-observation used to calculate Total Sleep Time, Wake After Sleep Onset, Sleep Onset Latency, Sleep Efficiency, and Day ratings.
Time Frame
4-week follow-up
Title
Sleep diary
Description
Daily self-observation used to calculate Total Sleep Time, Wake After Sleep Onset, Sleep Onset Latency, Sleep Efficiency, and Day ratings.
Time Frame
18-week follow-up
Title
Sleep diary
Description
Daily self-observation used to calculate Total Sleep Time, Wake After Sleep Onset, Sleep Onset Latency, Sleep Efficiency, and Day ratings.
Time Frame
48-week follow-up
Secondary Outcome Measure Information:
Title
Anxiety
Description
Measured with the HADS
Time Frame
Baseline
Title
Anxiety
Description
HADS
Time Frame
4-week follow-up
Title
Anxiety
Description
HADS
Time Frame
18-week follow-up
Title
Anxiety
Description
HADS
Time Frame
48-week follow-up
Title
Depression
Description
CES-D
Time Frame
Baseline
Title
Depression
Description
CES-D
Time Frame
4 week follow-up
Title
Depression
Description
CES-D
Time Frame
18-week follow-up
Title
Depression
Description
CES-D
Time Frame
48-week follow-up
Title
Sleep medication
Description
Sleep medication as measured by the sleep diary
Time Frame
Baseline
Title
Sleep medication
Description
Sleep medication as measured by the sleep diary
Time Frame
4-week follow-up
Title
Sleep medication
Description
Sleep medication as measured by the sleep diary
Time Frame
18-week follow-up
Title
Sleep medication
Description
Sleep medication as measured by the sleep diary
Time Frame
48-week follow-up
Title
Insomnia Severity
Description
Insomnia Severity Index
Time Frame
Baseline
Title
Insomnia severity
Description
Insomnia Severity Index
Time Frame
four-week follow-up
Title
Insomnia severity
Description
Insomnia Severity Index
Time Frame
18-week follow-up
Title
Insomnia severity
Description
Insomnia Severity Index
Time Frame
48-week follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Insomnia Access to the internet Exclusion Criteria: Alcohol or substance abuse Being suicidal Sleep apnea Schizophrenic or having a psychosis disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaap Lancee, MSc
Organizational Affiliation
Utrecht University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Utrecht University
City
Utrecht
ZIP/Postal Code
3508TC
Country
Netherlands

12. IPD Sharing Statement

Links:
URL
http://www.insomnie.nl
Description
Popular scientific website about insomnia

Learn more about this trial

Internet Delivered Self-Help CBT for Insomnia

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