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NightmaresPhase 1/2NCT00291031

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

A Phase 1/2 study testing Imagery Rehearsal Therapy (IRT) in people with Nightmares and Anxiety Disorders, run by GGZ Centraal at 3 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Nightmares, Anxiety Disorders, Mood Disorders
What is being tested?
Imagery Rehearsal Therapy (IRT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
112 participants
Where
3 sitesNetherlands
Study dates
Feb 2006to Aug 2011
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Minimum of 3 nightmares per month
  • Nightmares are associated with distress in daily life
  • Subject wants to get treatment for the nightmares

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country.

Netherlands3 sites

  • GGZ Centraal, De Meregaard

    Almere Stad, 1326 AD

  • GGZ Centraal, Zon & Schild

    Amersfoort, 3818 EW

  • GGZ Centraal, De Rembrandthof

    Hilversum, 1200 AE

Other trials in Netherlands

About this study

Official title: 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.

Read the 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.

Being tested
Imagery Rehearsal Therapy (IRT)
Keywords
nightmare, sleep disorder, sleep, imagery rehearsal, anxiety disorders, mood disorders, personality disorders
Medical subject headings
Anxiety Disorders, Mood Disorders, Personality Disorders, Sleep Wake Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Imagery Rehearsal Therapy (IRT)Behavioural

    Also called 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.

Study groups in NCT00291031
Study groupRoleWhat they receive
IRTExperimentalPatients 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.
Receives: Behavioral: Imagery Rehearsal Therapy (IRT)
TAUNo interventionPatients 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Frequency of nightmares scored in prospective daily nightmare logs

    Measured: Daily logs for 18 weeks, then periods of 4 weeks every 3 months

  2. Frequency of nightmares scored on the Nightmare Frequency Questionnaire

    Measured: At beginning of trial, 4, 16, 30, 42 and 56 weeks

Secondary outcomes (8)

  1. Intensity of nightmares scored in prospective daily nightmare logs

    Measured: Daily logs for 18 weeks, then periods of 4 weeks every 3 months

  2. Effects of nightmares scored on the Nightmare Effects Survey

    Measured: 1, 4, 16, 30, 42 and 56 weeks

  3. Nightmare distress scored on the Nightmare Distress Questionnaire

    Measured: 1, 4, 16, 30, 42 and 56 weeks

  4. Sleep problems scored on the SLEEP-50

    Measured: 1, 4, 16, 30, 42 and 56 weeks

  5. Psychiatric symptoms scored on the Symptom Check List (SCL-90)

    Measured: 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)

    Measured: 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)

    Measured: 1, 4, 16, 30, 42 and 56 weeks

  8. Nightmare efficacy and content measured by Nightmare Efficacy & Content Questionnaire

    Measured: 1, 4, 16, 30, 42 and 56 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2006 (estimated)
  2. Study startFeb 2006
  3. Primary completionJan 2011
  4. Study completionAug 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
112 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00291031
Sponsor's protocol ID
WO-SG-114NM
Status last verified
Oct 2013
First submitted
10 Feb 2006
Last updated
17 Oct 2013
Results posted
No
Data monitoring committee
Yes

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.

    PubMed 11476655

  • 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.

    PubMed 16377217

  • 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.

    PubMed 1386215

  • 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.

    PubMed 15175092

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

    PubMed 11534880

  • 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.

    PubMed 16190812

  • 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.

    PubMed 15680291

  • 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.

    PubMed 15892433

  • 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.

    PubMed 26455674

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Imagery Rehearsal Therapy (IRT) in people with Nightmares and Anxiety Disorders, run by GGZ Centraal at 3 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency of nightmares scored in prospective daily nightmare logs (time frame: Daily logs for 18 weeks, then periods of 4 weeks every 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00291031, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2013.

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