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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Nightmares, Anxiety Disorders, Mood Disorders, Personality Disorders

Intervention / Treatment
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* Behavioral: Imagery Rehearsal Therapy (IRT)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IRT<br>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)<br>* 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.<br>* Other names: IRT;|
| No Intervention: TAU<br>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?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensity of nightmares scored in prospective daily nightmare logs |  | Daily logs for 18 weeks, then periods of 4 weeks every 3 months | 
| Effects of nightmares scored on the Nightmare Effects Survey |  | 1, 4, 16, 30, 42 and 56 weeks | 
| Nightmare distress scored on the Nightmare Distress Questionnaire |  | 1, 4, 16, 30, 42 and 56 weeks | 
| Sleep problems scored on the SLEEP-50 |  | 1, 4, 16, 30, 42 and 56 weeks | 
| Psychiatric symptoms scored on the Symptom Check List (SCL-90) |  | 1, 4, 16, 30, 42 and 56 weeks | 
| Symptoms of post-traumatic stress disorder scored on the Zelf Inventarisatie Lijst PTSS ZIL (= PTSD Inventory) |  | 1, 4, 16, 30, 42 and 56 weeks | 
| Quality of life scored on the abbreviated World Health Organization Quality of Life scale (WHOQoL-Bref) |  | 1, 4, 16, 30, 42 and 56 weeks | 
| Nightmare efficacy and content measured by Nightmare Efficacy & Content Questionnaire |  | 1, 4, 16, 30, 42 and 56 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sleep, nightmare, sleep disorder, imagery rehearsal, anxiety disorders, mood disorders, personality disorders