NCT01224912

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
479

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Oct 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

October 18, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 20, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

January 8, 2013

Status Verified

January 1, 2013

Enrollment Period

1.2 years

First QC Date

October 18, 2010

Last Update Submit

January 7, 2013

Conditions

Insomnia

Keywords

InsomniaInterventionSelf-helpInternet

Outcome Measures

Primary Outcomes (4)

  • Sleep diary

    Daily self-observation used to calculate Total Sleep Time, Wake After Sleep Onset, Sleep Onset Latency, Sleep Efficiency, and Day ratings.

    baseline

  • Sleep diary

    Daily self-observation used to calculate Total Sleep Time, Wake After Sleep Onset, Sleep Onset Latency, Sleep Efficiency, and Day ratings.

    4-week follow-up

  • Sleep diary

    Daily self-observation used to calculate Total Sleep Time, Wake After Sleep Onset, Sleep Onset Latency, Sleep Efficiency, and Day ratings.

    18-week follow-up

  • Sleep diary

    Daily self-observation used to calculate Total Sleep Time, Wake After Sleep Onset, Sleep Onset Latency, Sleep Efficiency, and Day ratings.

    48-week follow-up

Secondary Outcomes (16)

  • Anxiety

    Baseline

  • Anxiety

    4-week follow-up

  • Anxiety

    18-week follow-up

  • Anxiety

    48-week follow-up

  • Depression

    Baseline

  • +11 more secondary outcomes

Study Arms (1)

Internet Deliviered CBT for Insomnia

EXPERIMENTAL

Cognitive behavioral self-help method for insomnia via the Internet

Behavioral: Cognitive Behavioral Treatment

Interventions

Cognitive Behavioral TreatmentBEHAVIORAL

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).

Internet Deliviered CBT for Insomnia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Insomnia
  • Access to the internet

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Utrecht University

Utrecht, Utrecht, 3508TC, Netherlands

Location

Related Links

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Jaap Lancee, MSc

    Utrecht University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 18, 2010

First Posted

October 20, 2010

Study Start

October 1, 2010

Primary Completion

December 1, 2011

Study Completion

October 1, 2012

Last Updated

January 8, 2013

Record last verified: 2013-01

Locations

NL(1)