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

Primary Purpose

Insomnia

Status

Completed

Phase

Phase 3

Locations

Netherlands

Study Type

Interventional

Intervention

CBT for insomnia

About this trial

This is an interventional treatment trial for Insomnia focused on measuring Insomnia, Intervention, Self-help, Internet

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Insomnia
Access to internet
Dutch citizen

Exclusion Criteria:

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

Sites / Locations

Utrecht University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

CBT for insomnia with feedback

CBT for insomnia without feedback

Arm Description

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

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

Outcomes

Primary Outcome Measures

Sleep diary

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

Diary

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

Diary

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

Secondary Outcome Measures

Insomnia Severity

Insomnia Severity Index

Insomnia severity

Insomnia Severity Index

Insomnia Severity

Insomnia Severity Index

Anxiety

HADS

Anxiety

HADS

Anxiety

HADS

Depression

CES-D

Depression

CES-D

Depression

CES-D

Full Information

NCT ID

NCT01456637

First Posted

October 20, 2011

Last Updated

January 7, 2013

Sponsor

Utrecht University

1. Study Identification

Unique Protocol Identification Number

NCT01456637

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2013

Overall Recruitment Status

Completed

Study Start Date

October 2011 (undefined)

Primary Completion Date

May 2012 (Actual)

Study Completion Date

December 2012 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Utrecht University

4. Oversight

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Insomnia

Keywords

Insomnia, Intervention, Self-help, Internet

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

262 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CBT for insomnia with feedback

Arm Type

Experimental

Arm Description

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

Arm Title

CBT for insomnia without feedback

Arm Type

Experimental

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

CBT for insomnia

Intervention Description

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).

Primary Outcome Measure Information:

Title

Sleep diary

Description

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

Time Frame

baseline

Title

Diary

Description

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

Time Frame

4-week follow-up

Title

Diary

Description

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

Time Frame

6 month follow-up

Secondary Outcome Measure Information:

Title

Insomnia Severity

Description

Insomnia Severity Index

Time Frame

baseline

Title

Insomnia severity

Description

Insomnia Severity Index

Time Frame

4-week follow-up

Title

Insomnia Severity

Description

Insomnia Severity Index

Time Frame

6 month follow-up

Title

Anxiety

Description

HADS

Time Frame

baseline

Title

Anxiety

Description

HADS

Time Frame

4-week follow-up

Title

Anxiety

Description

HADS

Time Frame

6-month follow-up

Title

Depression

Description

CES-D

Time Frame

baseline

Title

Depression

Description

CES-D

Time Frame

4-week follow-up

Title

Depression

Description

CES-D

Time Frame

6-month follow-up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Insomnia Access to internet Dutch citizen Exclusion Criteria: Alcohol or substance abuse Being suicidal Sleep apnea Schizophrenic or having a psychosis disorder

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jaap Lancee, PhD

Organizational Affiliation

Utrecht University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Utrecht University

City

Utrecht

ZIP/Postal Code

3508YC

Country

Netherlands

12. IPD Sharing Statement

Links:

URL

http://www.insomnie.nl

Description

Link Text: Popular scientific website about insomnia

Learn more about this trial

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

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