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

• Sponsor: Utrecht University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01456637
• Collaborator: (none)
• Enrollment: 262
• Location: 1
• Arms: 2
• Duration (Months): 14
• Patients Per Site Per Month: 18.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Insomnia	Behavioral: CBT for insomnia	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 262 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Online Self-Help Intervention for Insomnia: With or Without Feedback
• Study Start Date: Oct 1, 2011
• Actual Primary Completion Date: May 1, 2012
• Actual Study Completion Date: Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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).

Outcome Measures

Primary Outcome Measures

1. Sleep diary [baseline]

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

2. Diary [4-week follow-up]

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

3. Diary [6 month follow-up]

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

Secondary Outcome Measures

1. Insomnia Severity [baseline]

   Insomnia Severity Index

2. Insomnia severity [4-week follow-up]

   Insomnia Severity Index

3. Insomnia Severity [6 month follow-up]

   Insomnia Severity Index

4. Anxiety [baseline]

   HADS

5. Anxiety [4-week follow-up]

   HADS

6. Anxiety [6-month follow-up]

   HADS

7. Depression [baseline]

   CES-D

8. Depression [4-week follow-up]

   CES-D

9. Depression [6-month follow-up]

   CES-D

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Utrecht University	Utrecht		Netherlands	3508YC

Sponsors and Collaborators

• Utrecht University

Investigators

• Principal Investigator: Jaap Lancee, PhD, Utrecht University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Link Text: Popular scientific website about insomnia

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01456637
• Other Study ID Numbers: FPG-20106524
• First Posted: Oct 21, 2011
• Last Update Posted: Jan 8, 2013
• Last Verified: Jan 1, 2013

• Keywords provided by , ,: Insomnia; Intervention; Self-help; Internet
• Additional relevant MeSH terms: Sleep Initiation and Maintenance Disorders

Study Results

No Results Posted as of Jan 8, 2013