A Self-Help Method for Nightmares | NCT00513045

Studies
A Self-Help Method for Nightmares

NCT00513045

Sponsor

Utrecht University

Status

Completed

Last Update Posted

Nov 19, 2008Estimated

Enrollment

399Actual

Phase

Not Applicable

Conditions

Nightmares

Interventions

IRT
Exposure

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2007

Primary Completion Date

Sep 2008Actual

Completion Date

Nov 2008Actual

First Submitted Date

Aug 7, 2007

First Submission Date that Met QC Criteria

Aug 7, 2007

First Posted Date

Aug 8, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 18, 2008

Last Update Posted Date

Nov 19, 2008Estimated

Name	Class
Fonds Psychische Gezondheid	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The objective of this study is to validate a newly designed self-help treatment for nightmares. This self-help treatment is based on Imagery Rehearsal Therapy. This treatment will be validated in comparison to an exposure treatment a diary condition and a waiting list condition.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

399Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
IRT	Experimental	Intervention based on Imagery Rehearsal Therapy	Behavioral: IRT
Exposure	Active Comparator	Treatment based on exposure	Behavioral: Exposure
Nightmare diary	No Intervention	Recording nightmares in a diary
Waiting list	No Intervention	Waiting list

Interventions

Name	Type	Description	Arm Group Labels	Other Names
IRT	Behavioral	Cognitive behavior intervention	IRT
Exposure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Nightmare frequency		1 year
Nightmare distress		1 year

Secondary Outcomes

Measure	Description	Time Frame
Sleep quality		1 year
Sleep complaints		1 year
Anxiety ratings

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Suffering from Nightmares
Access to internet
A valid e-mail address
Be able to understand Dutch

Exclusion Criteria:

Severe posttraumatic complaints
Severe depression
High anxiety ratings
In therapy for post traumatic stress disorder
Being suicidal
Schizophrenic or having a psychosis episode

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jan Van den Bout, Prof. dr.	Utrecht University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Utrecht University		Utrecht	Utrecht	3508TC	Netherlands