Clinical trial NCT00291031: Study of the Effect of Imagery Rehearsal Therapy (IRT) of Nightmares
Official title: A Randomised Controlled Trial of Imagery Rehearsal Therapy (IRT) of Nightmares in a Psychiatric Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Nightmares
Anxiety Disorders
Mood Disorders
Personality Disorders
Keywords: nightmare
sleep disorder
sleep
imagery rehearsal
anxiety disorders
mood disorders
personality disorders
Lead sponsor: GGZ Centraal
Sponsor class: OTHER
Collaborators: name: Utrecht University
First posted: 2006-02-13
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Frequency of nightmares scored in prospective daily nightmare logs
timeFrame: Daily logs for 18 weeks, then periods of 4 weeks every 3 months
measure: Frequency of nightmares scored on the Nightmare Frequency Questionnaire
timeFrame: At beginning of trial, 4, 16, 30, 42 and 56 weeks
Secondary outcomes:
measure: Intensity of nightmares scored in prospective daily nightmare logs
timeFrame: Daily logs for 18 weeks, then periods of 4 weeks every 3 months
measure: Effects of nightmares scored on the Nightmare Effects Survey
timeFrame: 1, 4, 16, 30, 42 and 56 weeks
measure: Nightmare distress scored on the Nightmare Distress Questionnaire
timeFrame: 1, 4, 16, 30, 42 and 56 weeks
measure: Sleep problems scored on the SLEEP-50
timeFrame: 1, 4, 16, 30, 42 and 56 weeks
measure: Psychiatric symptoms scored on the Symptom Check List (SCL-90)
timeFrame: 1, 4, 16, 30, 42 and 56 weeks
measure: Symptoms of post-traumatic stress disorder scored on the Zelf Inventarisatie Lijst PTSS ZIL (= PTSD Inventory)
timeFrame: 1, 4, 16, 30, 42 and 56 weeks
measure: Quality of life scored on the abbreviated World Health Organization Quality of Life scale (WHOQoL-Bref)
timeFrame: 1, 4, 16, 30, 42 and 56 weeks
measure: Nightmare efficacy and content measured by Nightmare Efficacy & Content Questionnaire
timeFrame: 1, 4, 16, 30, 42 and 56 weeks
Other outcomes:
Locations:
city: Almere
country: Netherlands
facility: GGZ Centraal, De Meregaard
city: Amersfoort
country: Netherlands
facility: GGZ Centraal, Zon & Schild
city: Hilversum
country: Netherlands
facility: GGZ Centraal, De Rembrandthof
Study officials:
affiliation: GGZ Centraal (previously Symfora groep)
name: Annette M. van Schagen, MA
role: PRINCIPAL_INVESTIGATOR
affiliation: Utrecht University
name: Jan van den Bout, PhD
role: STUDY_CHAIR
affiliation: Max-Planck-Institute of Psychiatry
name: Victor I. Spoormaker, PhD
role: STUDY_CHAIR
affiliation: University of Amsterdam
name: Jaap Lancee, PhD
role: STUDY_CHAIR
References:
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citation: Spoormaker VI, Schredl M, van den Bout J. Nightmares: from anxiety symptom to sleep disorder. Sleep Med Rev. 2006 Feb;10(1):19-31. doi: 10.1016/j.smrv.2005.06.001. Epub 2005 Dec 27.
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citation: Spoormaker VI, Verbeek I, van den Bout J, Klip EC. Initial validation of the SLEEP-50 questionnaire. Behav Sleep Med. 2005;3(4):227-46. doi: 10.1207/s15402010bsm0304_4.
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citation: van de Willige G, Wiersma D, Nienhuis FJ, Jenner JA. Changes in quality of life in chronic psychiatric patients: a comparison between EuroQol (EQ-5D) and WHOQoL. Qual Life Res. 2005 Mar;14(2):441-51. doi: 10.1007/s11136-004-0689-y.
citation: van Schagen AM, Lancee J, de Groot IW, Spoormaker VI, van den Bout J. Imagery rehearsal therapy in addition to treatment as usual for patients with diverse psychiatric diagnoses suffering from nightmares: a randomized controlled trial. J Clin Psychiatry. 2015 Sep;76(9):e1105-13. doi: 10.4088/JCP.14m09216.