Internet Delivered Self-Help CBT for Insomnia

Phase 3 Study of Internet-based Self-help for Insomnia: Factors That Are Associated With Success of the Intervention

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.

Study Overview

• Status: Completed
• Conditions: Insomnia
• Intervention / Treatment: Behavioral: Cognitive Behavioral Treatment

• Study Type: Interventional
• Enrollment (Actual): 479
• Phase: Phase 3

Contacts and Locations

Study Locations

• Netherlands
  • Utrecht, Netherlands, 3508TC
    • Utrecht University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Insomnia
• Access to the internet

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Internet Deliviered CBT for Insomnia; Cognitive behavioral self-help method for insomnia via the Internet

Behavioral: Cognitive Behavioral Treatment; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety	Measured with the HADS	Baseline
Anxiety	HADS	4-week follow-up
Anxiety	HADS	18-week follow-up
Anxiety	HADS	48-week follow-up
Depression	CES-D	Baseline
Depression	CES-D	4 week follow-up
Depression	CES-D	18-week follow-up
Depression	CES-D	48-week follow-up
Sleep medication	Sleep medication as measured by the sleep diary	Baseline
Sleep medication	Sleep medication as measured by the sleep diary	4-week follow-up
Sleep medication	Sleep medication as measured by the sleep diary	18-week follow-up
Sleep medication	Sleep medication as measured by the sleep diary	48-week follow-up
Insomnia Severity	Insomnia Severity Index	Baseline
Insomnia severity	Insomnia Severity Index	four-week follow-up
Insomnia severity	Insomnia Severity Index	18-week follow-up
Insomnia severity	Insomnia Severity Index	48-week follow-up

Collaborators and Investigators

• Sponsor: Utrecht University
• Investigators: Principal Investigator: Jaap Lancee, MSc, Utrecht University

Publications and helpful links

Helpful Links

• Popular scientific website about insomnia

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (ACTUAL): December 1, 2011
• Study Completion (ACTUAL): October 1, 2012

Study Registration Dates

• First Submitted: October 18, 2010
• First Submitted That Met QC Criteria: October 19, 2010
• First Posted (ESTIMATE): October 20, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): January 8, 2013
• Last Update Submitted That Met QC Criteria: January 7, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: Insomnia; Intervention; Self-help; Internet
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: UU-vandenBout-2