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

This study has been completed.
Sponsor:
Collaborator:
Utrecht University
Information provided by (Responsible Party):
Annette van Schagen, GGZ Centraal
ClinicalTrials.gov Identifier:
NCT00291031
First received: February 10, 2006
Last updated: October 16, 2013
Last verified: October 2013
  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 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised Controlled Trial of Imagery Rehearsal Therapy (IRT) of Nightmares in a Psychiatric Population

Resource links provided by NLM:


Further study details as provided by GGZ Centraal:

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 ]

Enrollment: 112
Study Start Date: February 2006
Study Completion Date: August 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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 VU University of Amsterdam
  More Information

Additional Information:
Publications:
Responsible Party: Annette van Schagen, Clinical psychologist, GGZ Centraal
ClinicalTrials.gov Identifier: NCT00291031     History of Changes
Other Study ID Numbers: WO-SG-114NM
Study First Received: February 10, 2006
Last Updated: October 16, 2013
Health Authority: Netherlands: Dutch Health Care Inspectorate

Keywords provided by GGZ Centraal:
nightmare
sleep disorder
sleep
imagery rehearsal
anxiety disorders
mood disorders
personality disorders

Additional relevant MeSH terms:
Anxiety Disorders
Mood Disorders
Personality Disorders
Disease
Mental Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on September 22, 2014