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
  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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 September 22, 2014