NCT00513045

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
399

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 7, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 8, 2007

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

November 19, 2008

Status Verified

November 1, 2008

Enrollment Period

1.4 years

First QC Date

August 7, 2007

Last Update Submit

November 18, 2008

Conditions

Nightmares

Keywords

Nightmarestreatmentself-help

Outcome Measures

Primary Outcomes (2)

  • Nightmare frequency

    1 year

  • Nightmare distress

    1 year

Secondary Outcomes (5)

  • Sleep quality

    1 year

  • Sleep complaints

    1 year

  • Anxiety ratings

    1 year

  • Posttraumatic complaints (low - moderate - high)

    1 year

  • Depression ratings

    1 year

Study Arms (4)

IRT

EXPERIMENTAL

Intervention based on Imagery Rehearsal Therapy

Behavioral: IRT

Exposure

ACTIVE COMPARATOR

Treatment based on exposure

Behavioral: Exposure

Nightmare diary

NO INTERVENTION

Recording nightmares in a diary

Waiting list

NO INTERVENTION

Waiting list

Interventions

IRTBEHAVIORAL

Cognitive behavior intervention

IRT
ExposureBEHAVIORAL

Exposure intervention

Exposure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Suffering from Nightmares
  • Access to internet
  • A valid e-mail address
  • Be able to understand Dutch

You may not qualify if:

  • Severe posttraumatic complaints
  • Severe depression
  • High anxiety ratings
  • In therapy for post traumatic stress disorder
  • Being suicidal
  • Schizophrenic or having a psychosis episode

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Utrecht University

Utrecht, Utrecht, 3508TC, Netherlands

Location

Related Links

Study Officials

  • Jan Van den Bout, Prof. dr.

    Utrecht University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 7, 2007

First Posted

August 8, 2007

Study Start

April 1, 2007

Primary Completion

September 1, 2008

Study Completion

November 1, 2008

Last Updated

November 19, 2008

Record last verified: 2008-11

Locations

NL(1)