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Completed

NCT Number: NCT00291031

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

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.

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Key information

Conditions

Nightmares Anxiety Disorders Mental Disorders Mood Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Personality Disorders Signs and Symptoms Sleep Wake Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

GGZ Centraal, De Meregaard, Almere Stad, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Imagery Rehearsal Therapy (IRT)

Behavioral

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

Primary outcomes

  1. Frequency of nightmares scored in prospective daily nightmare logs

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

  2. Frequency of nightmares scored on the Nightmare Frequency Questionnaire

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

Secondary outcomes

  1. Intensity of nightmares scored in prospective daily nightmare logs

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

  2. Effects of nightmares scored on the Nightmare Effects Survey

    Time frame: 1, 4, 16, 30, 42 and 56 weeks

  3. Nightmare distress scored on the Nightmare Distress Questionnaire

    Time frame: 1, 4, 16, 30, 42 and 56 weeks

  4. Sleep problems scored on the SLEEP-50

    Time frame: 1, 4, 16, 30, 42 and 56 weeks

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

    Time frame: 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)

    Time frame: 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)

    Time frame: 1, 4, 16, 30, 42 and 56 weeks

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

    Time frame: 1, 4, 16, 30, 42 and 56 weeks

Sponsors and collaborators

Lead sponsor

GGZ Centraal

Other

Collaborators

  • Utrecht University

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2011
Study completion
2011
First posted
Feb 13, 2006
Registry last updated
Oct 17, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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