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

Phase 1

Completed

• Conditions: Nightmares; Anxiety Disorders; Mood Disorders; Personality Disorders
• Interventions: Behavioral: Imagery Rehearsal Therapy (IRT)

• Registration Number: NCT00291031
• Lead Sponsor: GGZ Centraal

Brief 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.

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 Timeline

• Study Start: 2006-02
• Study First Submitted: 2006-02-10
• Study First Submitted QC: 2006-02-10
• Study First Posted: 2006-02-13
• Primary Completion: 2011-01
• Study Completion: 2011-08
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-16
• Last Update Posted: 2013-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IRT	Imagery Rehearsal Therapy (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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (3)

GGZ Centraal, De Meregaard; 🇳🇱 Almere, Netherlands

GGZ Centraal, De Rembrandthof; 🇳🇱 Hilversum, Netherlands

GGZ Centraal, Zon & Schild; 🇳🇱 Amersfoort, Netherlands