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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by GGZ Centraal.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Utrecht University
Information provided by:
GGZ Centraal
ClinicalTrials.gov Identifier:
NCT00291031
First received: February 10, 2006
Last updated: January 21, 2011
Last verified: January 2011

February 10, 2006
January 21, 2011
February 2006
January 2011   (final data collection date for primary outcome measure)
  • Frequency of nightmares scored in prospective daily nightmare logs [ Time Frame: Daily logs for 18 weeks, then periods of 4 weeks every 3 months ] [ Designated as safety issue: No ]
  • Frequency of nightmares scored on the Nightmare Frequency Questionnaire [ Time Frame: At beginning of trial, 4, 16, 30, 42 and 56 weeks ] [ Designated as safety issue: No ]
Frequency of nightmares scored on the Nightmare Frequency Questionnaire at beginning of trial, 4, 16, 30, 42 and 56 weeks, and scored in prospective daily nightmare logs.
Complete list of historical versions of study NCT00291031 on ClinicalTrials.gov Archive Site
  • Intensity of nightmares scored in prospective daily nightmare logs [ Time Frame: Daily logs for 18 weeks, then periods of 4 weeks every 3 months ] [ Designated as safety issue: No ]
  • Effects of nightmares scored on the Nightmare Effects Survey [ Time Frame: 1, 4, 16, 30, 42 and 56 weeks ] [ Designated as safety issue: No ]
  • Nightmare distress scored on the Nightmare Distress Questionnaire [ Time Frame: 1, 4, 16, 30, 42 and 56 weeks ] [ Designated as safety issue: No ]
  • Sleep problems scored on the SLEEP-50 [ Time Frame: 1, 4, 16, 30, 42 and 56 weeks ] [ Designated as safety issue: No ]
  • Psychiatric symptoms scored on the Symptom Check List (SCL-90) [ Time Frame: 1, 4, 16, 30, 42 and 56 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Nightmare efficacy and content measured by Nightmare Efficacy & Content Questionnaire [ Time Frame: 1, 4, 16, 30, 42 and 56 weeks ] [ Designated as safety issue: No ]
  • Intensity of nightmares scored in prospective daily nightmare logs.
  • Effects of nightmares scored on the Nightmare Effects Survey.
  • Nightmare distress scored on the Nightmare Distress Questionnaire.
  • Sleep problems scored on the SLEEP-50.
  • Psychiatric symptoms scored on the Symptom Check List (SCL-90).
  • Symptoms of post-traumatic stress disorder scored on the Zelf Inventarisatie Lijst PTSS (ZIL, PTSD Inventory).
  • Quality of life scored on the World Health Organization Quality of Life scale (WHOQoL).
Not Provided
Not Provided
 
Study of the Effect of Imagery Rehearsal Therapy (IRT) of Nightmares
A Randomised Controlled Trial of Imagery Rehearsal Therapy (IRT) of Nightmares in a Psychiatric Population

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.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Nightmares
  • Anxiety Disorders
  • Mood Disorders
  • Personality Disorders
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
  • 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.
    Intervention: Behavioral: Imagery Rehearsal Therapy (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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
July 2011
January 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00291031
WO-SG-114NM
Yes
Annette van Schagen MA, Clinical Psychologist, GGZ Centraal, Innova (previously named Symfora groep)
GGZ Centraal
Utrecht University
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
GGZ Centraal
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP