Study of the Effect of Imagery Rehearsal Therapy (IRT) of Nightmares
Recruitment status was Active, not recruiting
| Tracking Information | |||||||||||||
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| First Received Date ICMJE | February 10, 2006 | ||||||||||||
| Last Updated Date | January 21, 2011 | ||||||||||||
| Start Date ICMJE | February 2006 | ||||||||||||
| Estimated Primary Completion Date | January 2011 (final data collection date for primary outcome measure) | ||||||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
Frequency of nightmares scored on the Nightmare Frequency Questionnaire at beginning of trial, 4, 16, 30, 42 and 56 weeks, and scored in prospective daily nightmare logs. | ||||||||||||
| Change History | Complete list of historical versions of study NCT00291031 on ClinicalTrials.gov Archive Site | ||||||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Descriptive Information | |||||||||||||
| Brief Title ICMJE | Study of the Effect of Imagery Rehearsal Therapy (IRT) of Nightmares | ||||||||||||
| Official Title ICMJE | A Randomised Controlled Trial of Imagery Rehearsal Therapy (IRT) of Nightmares in a Psychiatric Population | ||||||||||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||||||
| Study Phase | Phase 1 Phase 2 |
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| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | 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 Name: IRT |
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| Study Arm (s) |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||
| Recruitment Status ICMJE | Active, not recruiting | ||||||||||||
| Estimated Enrollment ICMJE | 100 | ||||||||||||
| Estimated Completion Date | July 2011 | ||||||||||||
| Estimated Primary Completion Date | January 2011 (final data collection date for primary outcome measure) | ||||||||||||
| Eligibility Criteria ICMJE | 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:
Exclusion Criteria:
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| Gender | Both | ||||||||||||
| Ages | 18 Years to 65 Years | ||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||
| Location Countries ICMJE | Netherlands | ||||||||||||
| Administrative Information | |||||||||||||
| NCT Number ICMJE | NCT00291031 | ||||||||||||
| Other Study ID Numbers ICMJE | WO-SG-114NM | ||||||||||||
| Has Data Monitoring Committee | Yes | ||||||||||||
| Responsible Party | Annette van Schagen MA, Clinical Psychologist, GGZ Centraal, Innova (previously named Symfora groep) | ||||||||||||
| Study Sponsor ICMJE | GGZ Centraal | ||||||||||||
| Collaborators ICMJE | Utrecht University | ||||||||||||
| Investigators ICMJE |
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| Information Provided By | GGZ Centraal | ||||||||||||
| Verification Date | January 2011 | ||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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