NCT01456637

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
262

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Oct 2011

Shorter than P25 for phase_3

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, 2011

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

October 20, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 21, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

January 8, 2013

Status Verified

January 1, 2013

Enrollment Period

7 months

First QC Date

October 20, 2011

Last Update Submit

January 7, 2013

Conditions

Insomnia

Keywords

InsomniaInterventionSelf-helpInternet

Outcome Measures

Primary Outcomes (3)

  • Sleep diary

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

    baseline

  • Diary

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

    4-week follow-up

  • Diary

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

    6 month follow-up

Secondary Outcomes (9)

  • Insomnia Severity

    baseline

  • Insomnia severity

    4-week follow-up

  • Insomnia Severity

    6 month follow-up

  • Anxiety

    baseline

  • Anxiety

    4-week follow-up

  • +4 more secondary outcomes

Study Arms (2)

CBT for insomnia with feedback

EXPERIMENTAL

In this arm participants received internet based self-help CBT for insomnia with e-mail feedback form a therapist.

Behavioral: CBT for insomnia

CBT for insomnia without feedback

EXPERIMENTAL

In this arm participants receive internet based self-help CBT for insomnia without feedback from a therapist.

Behavioral: CBT for insomnia

Interventions

CBT for insomniaBEHAVIORAL

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).

CBT for insomnia with feedbackCBT for insomnia without feedback

Eligibility Criteria

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

You may qualify if:

  • Insomnia
  • Access to internet
  • Dutch citizen

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, 3508YC, 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, PhD

    Utrecht University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 20, 2011

First Posted

October 21, 2011

Study Start

October 1, 2011

Primary Completion

May 1, 2012

Study Completion

December 1, 2012

Last Updated

January 8, 2013

Record last verified: 2013-01

Locations

NL(1)