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

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

Study Description

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.

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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 ]

Eligibility Criteria

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

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

Contacts and Locations

Locations

Netherlands

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

Investigators

• 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

More Information

Additional Information:

A website with information on nightmares, and other sleep problems. Sponsored by Utrecht University and Fonds Psychische Gezondheid 

The website of Symfora groep, Centres for Mental Health Care 

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. doi: 10.1001/jama.286.5.537.

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.

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. doi: 10.1001/archpsyc.1992.01820080059010.

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. doi: 10.1111/j.1365-2869.2004.00394.x.

Rothbaum BO, Mellman TA. Dreams and exposure therapy in PTSD. J Trauma Stress. 2001 Jul;14(3):481-90. doi: 10.1023/A:1011104521887.

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.

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. doi: 10.1016/j.sleep.2004.06.003.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• 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
• Last Update Posted: October 17, 2013
• Last Verified: October 2013

Keywords provided by Annette van Schagen, GGZ Centraal:

nightmare; sleep disorder; sleep; imagery rehearsal; anxiety disorders; mood disorders; personality disorders

Additional relevant MeSH terms:

Disease; Anxiety Disorders; Personality Disorders; Mood Disorders; Pathologic Processes; Mental Disorders