Study of the Effect of Imagery Rehearsal Therapy (IRT) of Nightmares - Full Text View

Sponsors and Collaborators:	Symfora groep Utrecht University
Information provided by:	Symfora groep
ClinicalTrials.gov Identifier:	NCT00291031

Purpose

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	Intervention	Phase
Nightmares Anxiety Disorders Mood Disorders Personality Disorders	Behavioral: Imagery Rehearsal Therapy (IRT)	Phase I Phase II

MedlinePlus related topics: Anxiety Personality Disorders Sleep Disorders

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Dose Comparison, Single Group Assignment, Efficacy Study
Official Title:	A Randomised Controlled Trial of Imagery Rehearsal Therapy (IRT) of Nightmares in a Psychiatric Population

Further study details as provided by Symfora groep:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	100
Study Start Date:	February 2006
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
IRT: Experimental 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.
TAU: No Intervention 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.

Arms

Assigned Interventions

IRT: Experimental

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.

TAU: No Intervention

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.

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

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Patients referred to 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00291031

Contacts

Contact: Annette van Schagen, MA	+31 36 5210200/+31 6 13258843	A.van.Schagen@symfora.nl
Contact: Eveliene Schut	+31 33 4609568	E.Schut@symfora.nl

Locations

Netherlands
Symfora groep, Location Zon & Schild	Active, not recruiting
Amersfoort, Netherlands, 3818 EW
Symfora groep, Location De Rembrandthof	Recruiting
Hilversum, Netherlands, 1200 AE
Contact: Annette van Schagen, MA +31 6 13258843 A.van.Schagen@symfora.nl
Principal Investigator: Annette van Schagen, MA
Symfora groep, Location De Meregaard	Recruiting
Almere, Netherlands, 1326 AD
Contact: Annette van Schagen, MA +31 36 5210200 A.van.Schagen@symfora.nl
Principal Investigator: Annette van Schagen, MA

Sponsors and Collaborators

Symfora groep

Utrecht University

Investigators

Principal Investigator:	Annette van Schagen, MA	Symfora groep
Study Chair:	Jan van den Bout, PhD	Utrecht University
Study Chair:	Victor Spoormaker, PhD	Max-Planck-Institute of Psychiatry

More Information

Additional Information:

A website with information on nightmares, and other sleep problems. Sponsored by Utrecht University and Fonds Psychische Gezondheid This link exits the ClinicalTrials.gov site

The website of Symfora groep, Centres for Mental Health Care This link exits the ClinicalTrials.gov site

Publications:

Krakow B, Hollifield M, Johnston L, Koss M, Schrader R, Warner TD, Tandberg D, Lauriello J, McBride L, Cutchen L, Cheng D, Emmons S, Germain A, Melendrez D, Sandoval D, Prince H. Imagery rehearsal therapy for chronic nightmares in sexual assault survivors with posttraumatic stress disorder: a randomized controlled trial. JAMA. 2001 Aug 1;286(5):537-45.

Spoormaker VI, Schredl M, Bout J. Nightmares: from anxiety symptom to sleep disorder. Sleep Med Rev. 2006 Feb;10(1):19-31. Epub 2005 Dec 27.

Benca RM, Obermeyer WH, Thisted RA, Gillin JC. Sleep and psychiatric disorders. A meta-analysis. Arch Gen Psychiatry. 1992 Aug;49(8):651-68; discussion 669-70.

Blagrove M, Farmer L, Williams E. The relationship of nightmare frequency and nightmare distress to well-being. J Sleep Res. 2004 Jun;13(2):129-36.

Rothbaum BO, Mellman TA. Dreams and exposure therapy in PTSD. J Trauma Stress. 2001 Jul;14(3):481-90. Review.

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.

Strine TW, Chapman DP. Associations of frequent sleep insufficiency with health-related quality of life and health behaviors. Sleep Med. 2005 Jan;6(1):23-7.

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.

Responsible Party:	Symfora groep ( Annette van Schagen MA )
Study ID Numbers:	WO-SG-114NM
Study First Received:	February 10, 2006
Last Updated:	March 18, 2009
ClinicalTrials.gov Identifier:	NCT00291031 History of Changes
Health Authority:	Netherlands: Dutch Health Care Inspectorate

Keywords provided by Symfora groep:

nightmare
sleep disorder
sleep
imagery rehearsal

anxiety disorders
mood disorders
personality disorders

Study placed in the following topic categories:

Anxiety Disorders
Mental Disorders
Mood Disorders
Sleep Disorders
Personality Disorders

Additional relevant MeSH terms:

Pathologic Processes
Disease
Anxiety Disorders

Mental Disorders
Mood Disorders
Personality Disorders

ClinicalTrials.gov processed this record on May 06, 2009