search
Back to results

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

Primary Purpose

Nightmares, Anxiety Disorders, Mood Disorders

Status
Completed
Phase
Phase 1
Locations
Netherlands
Study Type
Interventional
Intervention
Imagery Rehearsal Therapy (IRT)
Sponsored by
GGZ Centraal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nightmares focused on measuring nightmare, sleep disorder, sleep, imagery rehearsal, anxiety disorders, mood disorders, personality disorders

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • GGZ Centraal, De Meregaard
  • GGZ Centraal, Zon & Schild
  • GGZ Centraal, De Rembrandthof

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

IRT

TAU

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Frequency of nightmares scored in prospective daily nightmare logs
Frequency of nightmares scored on the Nightmare Frequency Questionnaire

Secondary Outcome Measures

Intensity of nightmares scored in prospective daily nightmare logs
Effects of nightmares scored on the Nightmare Effects Survey
Nightmare distress scored on the Nightmare Distress Questionnaire
Sleep problems scored on the SLEEP-50
Psychiatric symptoms scored on the Symptom Check List (SCL-90)
Symptoms of post-traumatic stress disorder scored on the Zelf Inventarisatie Lijst PTSS ZIL (= PTSD Inventory)
Quality of life scored on the abbreviated World Health Organization Quality of Life scale (WHOQoL-Bref)
Nightmare efficacy and content measured by Nightmare Efficacy & Content Questionnaire

Full Information

First Posted
February 10, 2006
Last Updated
October 16, 2013
Sponsor
GGZ Centraal
Collaborators
Utrecht University
search

1. Study Identification

Unique Protocol Identification Number
NCT00291031
Brief Title
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

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
GGZ Centraal
Collaborators
Utrecht University

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nightmares, Anxiety Disorders, Mood Disorders, Personality Disorders
Keywords
nightmare, sleep disorder, sleep, imagery rehearsal, anxiety disorders, mood disorders, personality disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
112 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IRT
Arm Type
Experimental
Arm Description
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.
Arm Title
TAU
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Imagery Rehearsal Therapy (IRT)
Other Intervention Name(s)
IRT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Frequency of nightmares scored in prospective daily nightmare logs
Time Frame
Daily logs for 18 weeks, then periods of 4 weeks every 3 months
Title
Frequency of nightmares scored on the Nightmare Frequency Questionnaire
Time Frame
At beginning of trial, 4, 16, 30, 42 and 56 weeks
Secondary Outcome Measure Information:
Title
Intensity of nightmares scored in prospective daily nightmare logs
Time Frame
Daily logs for 18 weeks, then periods of 4 weeks every 3 months
Title
Effects of nightmares scored on the Nightmare Effects Survey
Time Frame
1, 4, 16, 30, 42 and 56 weeks
Title
Nightmare distress scored on the Nightmare Distress Questionnaire
Time Frame
1, 4, 16, 30, 42 and 56 weeks
Title
Sleep problems scored on the SLEEP-50
Time Frame
1, 4, 16, 30, 42 and 56 weeks
Title
Psychiatric symptoms scored on the Symptom Check List (SCL-90)
Time Frame
1, 4, 16, 30, 42 and 56 weeks
Title
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
Title
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
Title
Nightmare efficacy and content measured by Nightmare Efficacy & Content Questionnaire
Time Frame
1, 4, 16, 30, 42 and 56 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Annette M. van Schagen, MA
Organizational Affiliation
GGZ Centraal (previously Symfora groep)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jan van den Bout, PhD
Organizational Affiliation
Utrecht University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Victor I. Spoormaker, PhD
Organizational Affiliation
Max-Planck-Institute of Psychiatry
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jaap Lancee, PhD
Organizational Affiliation
University of Amsterdam
Official's Role
Study Chair
Facility Information:
Facility Name
GGZ Centraal, De Meregaard
City
Almere
ZIP/Postal Code
1326 AD
Country
Netherlands
Facility Name
GGZ Centraal, Zon & Schild
City
Amersfoort
ZIP/Postal Code
3818 EW
Country
Netherlands
Facility Name
GGZ Centraal, De Rembrandthof
City
Hilversum
ZIP/Postal Code
1200 AE
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
11476655
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. doi: 10.1001/jama.286.5.537.
Results Reference
background
PubMed Identifier
16377217
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.
Results Reference
background
PubMed Identifier
1386215
Citation
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.
Results Reference
background
PubMed Identifier
15175092
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. doi: 10.1111/j.1365-2869.2004.00394.x.
Results Reference
background
PubMed Identifier
11534880
Citation
Rothbaum BO, Mellman TA. Dreams and exposure therapy in PTSD. J Trauma Stress. 2001 Jul;14(3):481-90. doi: 10.1023/A:1011104521887.
Results Reference
background
PubMed Identifier
16190812
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.
Results Reference
background
PubMed Identifier
15680291
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. doi: 10.1016/j.sleep.2004.06.003.
Results Reference
background
PubMed Identifier
15892433
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.
Results Reference
background
PubMed Identifier
26455674
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.
Results Reference
derived
Links:
URL
http://www.nachtmerries.org/
Description
A website with information on nightmares, and other sleep problems. Sponsored by Utrecht University and Fonds Psychische Gezondheid
URL
http://www.symfora.nl
Description
The website of Symfora groep, Centres for Mental Health Care

Learn more about this trial

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

We'll reach out to this number within 24 hrs