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Study of the Effect of Imagery Rehearsal Therapy (IRT) of Nightmares

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ClinicalTrials.gov Identifier: NCT00291031
Recruitment Status : Completed
First Posted : February 13, 2006
Last Update Posted : October 17, 2013
Utrecht University
Information provided by (Responsible Party):
Annette van Schagen, GGZ Centraal

Brief Summary:
The purpose of this study is to determine whether Imagery Rehearsal Therapy(IRT) is effective in the reduction of the number of nightmares and the nightmare distress in a population of patients with psychiatric disorders.

Condition or disease Intervention/treatment Phase
Nightmares Anxiety Disorders Mood Disorders Personality Disorders Behavioral: Imagery Rehearsal Therapy (IRT) Phase 1 Phase 2

Detailed Description:

Within the normal population 4-8% of the people suffer regularly from nightmares. Clinical observations show that nightmares are a common problem for patients who suffer from all kinds of psychiatric disorders, and not just for the patients diagnosed with PTSD. Often nightmares can lead to sleep disorders, which have a negative impact on emotional well-being and cognitive functioning during the day. As well as this a strong relationship between severity of nightmares and severity of psychopathology has been found. This gives a strong argument for treatment of nightmares as a symptom, separate from the psychiatric disorder.

A few controlled studies of the treatment of nightmares have been published, in which behavioral therapy, relaxation techniques, exposure and systematic desensitization have been studied, all of which have shown positive results. But these techniques do not seem to reduce the number of nightmares in patients who suffer from PTSD. These last few years more controlled studies of a cognitive behavioral technique called 'Imagery Rehearsal Therapy' (IRT) have been published. With IRT patients have to change the script of their nightmares into a different outcome, and rehearse this new script using cognitive imagery a few times a day.

Comparisons: treatment of nightmares with IRT compared to a waitlist control group who do not get IRT until 6 months later.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised Controlled Trial of Imagery Rehearsal Therapy (IRT) of Nightmares in a Psychiatric Population
Study Start Date : February 2006
Actual Primary Completion Date : January 2011
Actual Study Completion Date : August 2011

Arm Intervention/treatment
Experimental: IRT
Patients randomly assigned to the IRT condition receive Imagery Rehearsal Therapy after 4 weeks since the entrance into the trial next to their treatment as usual.
Behavioral: Imagery Rehearsal Therapy (IRT)

Imagery Rehearsal Therapy is given by psychologists, psychotherapists or psychiatrists. The IRT therapists are all trained by Annette van Schagen, principal investigator.

IRT consists of six 1-hour sessions. The six sessions are given in a period of three months. Each session is described in the IRT Manual. The IRT Manual is devised by the principal investigator Annette van Schagen in colaboration with Victor Spoormaker PhD. There is a patient version of the IRT manual available for the patients, which includes descriptions of the IRT sessions and homework assignments.

Other Name: IRT

No Intervention: TAU
Patients that are randomly assigned to the waiting list control condition get treatment as usual (TAU) and complete the daily nightmare logs for a period of three months. These patients get the IRT intervention after waiting for 6 months.

Primary Outcome Measures :
  1. Frequency of nightmares scored in prospective daily nightmare logs [ Time Frame: Daily logs for 18 weeks, then periods of 4 weeks every 3 months ]
  2. Frequency of nightmares scored on the Nightmare Frequency Questionnaire [ Time Frame: At beginning of trial, 4, 16, 30, 42 and 56 weeks ]

Secondary Outcome Measures :
  1. Intensity of nightmares scored in prospective daily nightmare logs [ Time Frame: Daily logs for 18 weeks, then periods of 4 weeks every 3 months ]
  2. Effects of nightmares scored on the Nightmare Effects Survey [ Time Frame: 1, 4, 16, 30, 42 and 56 weeks ]
  3. Nightmare distress scored on the Nightmare Distress Questionnaire [ Time Frame: 1, 4, 16, 30, 42 and 56 weeks ]
  4. Sleep problems scored on the SLEEP-50 [ Time Frame: 1, 4, 16, 30, 42 and 56 weeks ]
  5. Psychiatric symptoms scored on the Symptom Check List (SCL-90) [ Time Frame: 1, 4, 16, 30, 42 and 56 weeks ]
  6. Symptoms of post-traumatic stress disorder scored on the Zelf Inventarisatie Lijst PTSS ZIL (= PTSD Inventory) [ Time Frame: 1, 4, 16, 30, 42 and 56 weeks ]
  7. Quality of life scored on the abbreviated World Health Organization Quality of Life scale (WHOQoL-Bref) [ Time Frame: 1, 4, 16, 30, 42 and 56 weeks ]
  8. Nightmare efficacy and content measured by Nightmare Efficacy & Content Questionnaire [ Time Frame: 1, 4, 16, 30, 42 and 56 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Patients referred to GGZ Centraal (previously Symfora groep) by their family doctor/GP for treatment of a psychiatric disorder. Patients that suffer from anxiety disorders, eating disorders, mood disorders and/or personality disorders.

Inclusion Criteria:

  • Minimum of 3 nightmares per month
  • Nightmares are associated with distress in daily life
  • Subject wants to get treatment for the nightmares

Exclusion Criteria:

  • Imagery rehearsal therapy for nightmares in the past
  • Psychotic disorders
  • Acute psychiatric crisis
  • Mentally challenged or neuropsychiatric syndrome
  • Severe addiction problems
  • Insufficient mastery of the Dutch language

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): NCT00291031

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GGZ Centraal, De Meregaard
Almere, Netherlands, 1326 AD
GGZ Centraal, Zon & Schild
Amersfoort, Netherlands, 3818 EW
GGZ Centraal, De Rembrandthof
Hilversum, Netherlands, 1200 AE
Sponsors and Collaborators
GGZ Centraal
Utrecht University
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Principal Investigator: Annette M. van Schagen, MA GGZ Centraal (previously Symfora groep)
Study Chair: Jan van den Bout, PhD Utrecht University
Study Chair: Victor I. Spoormaker, PhD Max-Planck-Institute of Psychiatry
Study Chair: Jaap Lancee, PhD University of Amsterdam
Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Annette van Schagen, Clinical psychologist, GGZ Centraal
ClinicalTrials.gov Identifier: NCT00291031    
Other Study ID Numbers: WO-SG-114NM
First Posted: February 13, 2006    Key Record Dates
Last Update Posted: October 17, 2013
Last Verified: October 2013
Keywords provided by Annette van Schagen, GGZ Centraal:
sleep disorder
imagery rehearsal
anxiety disorders
mood disorders
personality disorders
Additional relevant MeSH terms:
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Anxiety Disorders
Personality Disorders
Mood Disorders
Pathologic Processes
Mental Disorders