A Self-Help Method for Nightmares (Nightmares)

November 18, 2008 updated by: Utrecht University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

399

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: IRT
Intervention based on Imagery Rehearsal Therapy
Behavioral: IRT
Cognitive behavior intervention
ACTIVE_COMPARATOR: Exposure
Treatment based on exposure
Behavioral: Exposure
Exposure intervention
NO_INTERVENTION: Nightmare diary
Recording nightmares in a diary
NO_INTERVENTION: Waiting list

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Nightmare frequency
Time Frame: 1 year
1 year
Nightmare distress
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Sleep quality
Time Frame: 1 year
1 year
Sleep complaints
Time Frame: 1 year
1 year
Anxiety ratings
Time Frame: 1 year
1 year
Posttraumatic complaints (low - moderate - high)
Time Frame: 1 year
1 year
Depression ratings
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Utrecht University

Collaborators

Fonds Psychische Gezondheid

Investigators

  • Study Director: Jan Van den Bout, Prof. dr., Utrecht University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (ACTUAL)

September 1, 2008

Study Completion (ACTUAL)

November 1, 2008

Study Registration Dates

First Submitted

August 7, 2007

First Submitted That Met QC Criteria

August 7, 2007

First Posted (ESTIMATE)

August 8, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

November 19, 2008

Last Update Submitted That Met QC Criteria

November 18, 2008

Last Verified

November 1, 2008

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FPG20066126

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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