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
|Condition or disease||Intervention/treatment||Phase|
|Nightmares Anxiety Disorders Mood Disorders Personality Disorders||Behavioral: Imagery Rehearsal Therapy (IRT)||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||112 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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.
- Frequency of nightmares scored in prospective daily nightmare logs [ Time Frame: Daily logs for 18 weeks, then periods of 4 weeks every 3 months ]
- Frequency of nightmares scored on the Nightmare Frequency Questionnaire [ Time Frame: At beginning of trial, 4, 16, 30, 42 and 56 weeks ]
- Intensity of nightmares scored in prospective daily nightmare logs [ Time Frame: Daily logs for 18 weeks, then periods of 4 weeks every 3 months ]
- Effects of nightmares scored on the Nightmare Effects Survey [ Time Frame: 1, 4, 16, 30, 42 and 56 weeks ]
- Nightmare distress scored on the Nightmare Distress Questionnaire [ Time Frame: 1, 4, 16, 30, 42 and 56 weeks ]
- Sleep problems scored on the SLEEP-50 [ Time Frame: 1, 4, 16, 30, 42 and 56 weeks ]
- Psychiatric symptoms scored on the Symptom Check List (SCL-90) [ Time Frame: 1, 4, 16, 30, 42 and 56 weeks ]
- 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 ]
- 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 ]
- Nightmare efficacy and content measured by Nightmare Efficacy & Content Questionnaire [ Time Frame: 1, 4, 16, 30, 42 and 56 weeks ]
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
|GGZ Centraal, De Meregaard|
|Almere, Netherlands, 1326 AD|
|GGZ Centraal, Zon & Schild|
|Amersfoort, Netherlands, 3818 EW|
|GGZ Centraal, De Rembrandthof|
|Hilversum, Netherlands, 1200 AE|
|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|