A Self-Help Method for Nightmares - Full Text View

Sponsors and Collaborators:	Utrecht University Fonds Psychische Gezondheid
Information provided by:	Utrecht University
ClinicalTrials.gov Identifier:	NCT00513045

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study
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
IRT: Experimental Intervention based on Imagery Rehearsal Therapy	Behavioral: IRT Cognitive behavior intervention
Exposure: Active Comparator Treatment based on exposure	Behavioral: Exposure Exposure intervention
Nightmare diary: No Intervention Recording nightmares in a diary
Waiting list: No Intervention 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

Related Info This link exits the ClinicalTrials.gov site

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

Keywords provided by Utrecht University:

Nightmares
treatment
self-help

ClinicalTrials.gov processed this record on January 15, 2009