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A Self-Help Method for Nightmares (Nightmares)

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ClinicalTrials.gov Identifier: NCT00513045
Recruitment Status : Completed
First Posted : August 8, 2007
Last Update Posted : November 19, 2008
Sponsor:
Collaborator:
Fonds Psychische Gezondheid
Information provided by:
Utrecht University

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.

Condition or disease Intervention/treatment Phase
Nightmares Behavioral: IRT Behavioral: Exposure Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 399 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Self-Help Method for Nightmares
Study Start Date : April 2007
Actual Primary Completion Date : September 2008
Actual Study Completion Date : November 2008

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
Waiting list



Primary Outcome Measures :
  1. Nightmare frequency [ Time Frame: 1 year ]
  2. Nightmare distress [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Sleep quality [ Time Frame: 1 year ]
  2. Sleep complaints [ Time Frame: 1 year ]
  3. Anxiety ratings [ Time Frame: 1 year ]
  4. Posttraumatic complaints (low - moderate - high) [ Time Frame: 1 year ]
  5. Depression ratings [ Time Frame: 1 year ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00513045


Locations
Netherlands
Utrecht University
Utrecht, Netherlands, 3508TC
Sponsors and Collaborators
Utrecht University
Fonds Psychische Gezondheid
Investigators
Study Director: Jan Van den Bout, Prof. dr. Utrecht University

Additional Information:
Responsible Party: Utrecht University
ClinicalTrials.gov Identifier: NCT00513045     History of Changes
Other Study ID Numbers: FPG20066126
First Posted: August 8, 2007    Key Record Dates
Last Update Posted: November 19, 2008
Last Verified: November 2008

Keywords provided by Utrecht University:
Nightmares
treatment
self-help