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

October 16, 2013 updated by: Annette van Schagen, GGZ Centraal

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

112

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Almere, Netherlands, 1326 AD
        • GGZ Centraal, De Meregaard
      • Amersfoort, Netherlands, 3818 EW
        • GGZ Centraal, Zon & Schild
      • Hilversum, Netherlands, 1200 AE
        • GGZ Centraal, De Rembrandthof

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Frequency of nightmares scored in prospective daily nightmare logs
Time Frame: Daily logs for 18 weeks, then periods of 4 weeks every 3 months
Daily logs for 18 weeks, then periods of 4 weeks every 3 months
Frequency of nightmares scored on the Nightmare Frequency Questionnaire
Time Frame: At beginning of trial, 4, 16, 30, 42 and 56 weeks
At beginning of trial, 4, 16, 30, 42 and 56 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Intensity of nightmares scored in prospective daily nightmare logs
Time Frame: Daily logs for 18 weeks, then periods of 4 weeks every 3 months
Daily logs for 18 weeks, then periods of 4 weeks every 3 months
Effects of nightmares scored on the Nightmare Effects Survey
Time Frame: 1, 4, 16, 30, 42 and 56 weeks
1, 4, 16, 30, 42 and 56 weeks
Nightmare distress scored on the Nightmare Distress Questionnaire
Time Frame: 1, 4, 16, 30, 42 and 56 weeks
1, 4, 16, 30, 42 and 56 weeks
Sleep problems scored on the SLEEP-50
Time Frame: 1, 4, 16, 30, 42 and 56 weeks
1, 4, 16, 30, 42 and 56 weeks
Psychiatric symptoms scored on the Symptom Check List (SCL-90)
Time Frame: 1, 4, 16, 30, 42 and 56 weeks
1, 4, 16, 30, 42 and 56 weeks
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
1, 4, 16, 30, 42 and 56 weeks
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
1, 4, 16, 30, 42 and 56 weeks
Nightmare efficacy and content measured by Nightmare Efficacy & Content Questionnaire
Time Frame: 1, 4, 16, 30, 42 and 56 weeks
1, 4, 16, 30, 42 and 56 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GGZ Centraal

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

February 10, 2006

First Submitted That Met QC Criteria

February 10, 2006

First Posted (Estimate)

February 13, 2006

Study Record Updates

Last Update Posted (Estimate)

October 17, 2013

Last Update Submitted That Met QC Criteria

October 16, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WO-SG-114NM

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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