Online Self-Help Intervention for Insomnia: With or Without Feedback

Insomnia Clinical Trial

Official title:

Online Self-Help Intervention for Insomnia: With or Without Feedback

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01456637
• Other study ID #: FPG-20106524
• Status: Completed
• Phase: Phase 3
• First received: October 20, 2011
• Last updated: January 7, 2013
• Start date: October 2011
• Est. completion date: December 2012

Study information

• Verified date: January 2013
• Source: Utrecht University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 262
• Est. completion date: December 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Insomnia

• Access to internet

• Dutch citizen

Exclusion Criteria:

• Alcohol or substance abuse

• Being suicidal

• Sleep apnea

• Schizophrenic or having a psychosis disorder

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Insomnia

Intervention

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).

Locations

Country	Name	City	State
Netherlands	Utrecht University	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
Utrecht University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep diary	Daily self-observation used to calculate Total Sleep Time, Wake After Sleep Onset, Sleep Onset Latency, Sleep Efficiency, and Sleep Quality.	baseline	No
Primary	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	No
Primary	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	No
Secondary	Insomnia Severity	Insomnia Severity Index	baseline	No
Secondary	Insomnia severity	Insomnia Severity Index	4-week follow-up	No
Secondary	Insomnia Severity	Insomnia Severity Index	6 month follow-up	No
Secondary	Anxiety	HADS	baseline	No
Secondary	Anxiety	HADS	4-week follow-up	No
Secondary	Anxiety	HADS	6-month follow-up	No
Secondary	Depression	CES-D	baseline	No
Secondary	Depression	CES-D	4-week follow-up	No
Secondary	Depression	CES-D	6-month follow-up	No

External Links

•   Popular scientific website about insomnia