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

Anxiety Disorders Clinical Trial

Official title:

A Randomised Controlled Trial of Imagery Rehearsal Therapy (IRT) of Nightmares in a Psychiatric Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00291031
• Other study ID #: WO-SG-114NM
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: February 10, 2006
• Last updated: October 16, 2013
• Start date: February 2006
• Est. completion date: August 2011

Study information

• Verified date: October 2013
• Source: GGZ Centraal
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Dutch Health Care Inspectorate
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: August 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety Disorders
• Disease
• Mood Disorders
• Nightmares
• Personality Disorders

Intervention

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.

Locations

Country	Name	City	State
Netherlands	GGZ Centraal, De Meregaard	Almere
Netherlands	GGZ Centraal, Zon & Schild	Amersfoort
Netherlands	GGZ Centraal, De Rembrandthof	Hilversum

Sponsors (2)

Lead Sponsor	Collaborator
GGZ Centraal	Utrecht University

Country where clinical trial is conducted

Netherlands, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

Rothbaum BO, Mellman TA. Dreams and exposure therapy in PTSD. J Trauma Stress. 2001 Jul;14(3):481-90. Review. — View 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. Epub 2005 Dec 27. Review. — View 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. — View Citation

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of nightmares scored in prospective daily nightmare logs		Daily logs for 18 weeks, then periods of 4 weeks every 3 months	No
Primary	Frequency of nightmares scored on the Nightmare Frequency Questionnaire		At beginning of trial, 4, 16, 30, 42 and 56 weeks	No
Secondary	Intensity of nightmares scored in prospective daily nightmare logs		Daily logs for 18 weeks, then periods of 4 weeks every 3 months	No
Secondary	Effects of nightmares scored on the Nightmare Effects Survey		1, 4, 16, 30, 42 and 56 weeks	No
Secondary	Nightmare distress scored on the Nightmare Distress Questionnaire		1, 4, 16, 30, 42 and 56 weeks	No
Secondary	Sleep problems scored on the SLEEP-50		1, 4, 16, 30, 42 and 56 weeks	No
Secondary	Psychiatric symptoms scored on the Symptom Check List (SCL-90)		1, 4, 16, 30, 42 and 56 weeks	No
Secondary	Symptoms of post-traumatic stress disorder scored on the Zelf Inventarisatie Lijst PTSS ZIL (= PTSD Inventory)		1, 4, 16, 30, 42 and 56 weeks	No
Secondary	Quality of life scored on the abbreviated World Health Organization Quality of Life scale (WHOQoL-Bref)		1, 4, 16, 30, 42 and 56 weeks	No
Secondary	Nightmare efficacy and content measured by Nightmare Efficacy & Content Questionnaire		1, 4, 16, 30, 42 and 56 weeks	No

External Links

•   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