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A Self-Help Method for Nightmares

This study has been completed.
Sponsor:
Collaborator:
Fonds Psychische Gezondheid
Information provided by:
Utrecht University
ClinicalTrials.gov Identifier:
NCT00513045
First received: August 7, 2007
Last updated: November 18, 2008
Last verified: November 2008
History of Changes
  Purpose

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 Intervention
Nightmares
 Behavioral: IRT
Behavioral: Exposure

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Self-Help Method for Nightmares

Resource links provided by NLM:

MedlinePlus related topics: Anxiety
U.S. FDA Resources

Further study details as provided by Utrecht University:

Primary Outcome Measures:
  • Nightmare frequency [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Nightmare distress [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sleep quality [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Sleep complaints [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Anxiety ratings [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Posttraumatic complaints (low - moderate - high) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Depression ratings [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 399
Study Start Date: April 2007
Study Completion Date: November 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Utrecht University
ClinicalTrials.gov Identifier: NCT00513045     History of Changes
Other Study ID Numbers: FPG20066126
Study First Received: August 7, 2007
Last Updated: November 18, 2008
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Utrecht University:
Nightmares
treatment
self-help

ClinicalTrials.gov processed this record on May 19, 2013