NightmaresNightmaresNCT00513045
A Self-Help Method for Nightmares
A study testing IRT and Exposure in people with Nightmares, run by Utrecht University at 1 site in Netherlands.
Trial summary
The objective of this study is to validate a newly designed self-help treatment for nightmares. This self-help treatment is based on Imagery Rehearsal Therapy. This treatment will be validated in comparison to an exposure treatment a diary condition and a waiting list condition. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nightmares
- What is being tested?
- IRT and Exposure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 399 participants
- Where
- 1 siteNetherlands
- Study dates
- Apr 2007to Nov 2008
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Suffering from Nightmares
- Access to internet
- A valid e-mail address
- Be able to understand Dutch
Who cannot join
- Severe posttraumatic complaints
- Severe depression
- High anxiety ratings
- In therapy for post traumatic stress disorder
- Being suicidal
- Schizophrenic or having a psychosis episode
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study is to validate a newly designed self-help treatment for nightmares. This self-help treatment is based on Imagery Rehearsal Therapy. This treatment will be validated in comparison to an exposure treatment a diary condition and a waiting list condition.
- Conditions
- Nightmares
- Being tested
- IRT, Exposure
- Keywords
- Nightmares, treatment, self-help
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IRTBehavioural
Cognitive behavior intervention
ExposureBehavioural
Exposure intervention
| Study group | Role | What they receive |
|---|---|---|
| IRT | Experimental | Intervention based on Imagery Rehearsal Therapy Receives: Behavioral: IRT |
| Exposure | Active comparator | Treatment based on exposure Receives: Behavioral: Exposure |
| Nightmare diary | No intervention | Recording nightmares in a diary |
| Waiting list | No intervention | Waiting list |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nightmare frequency
Measured: 1 year
Nightmare distress
Measured: 1 year
Secondary outcomes (5)
Sleep quality
Measured: 1 year
Sleep complaints
Measured: 1 year
Anxiety ratings
Measured: 1 year
Posttraumatic complaints (low - moderate - high)
Measured: 1 year
Depression ratings
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2007 (estimated)
- Study startApr 2007
- Primary completionSep 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NightmaresStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 399 participants (actual)
Sponsor and investigators
- Lead sponsor
- Utrecht University
- Sponsor type
- University, hospital or other
- Collaborators
- Fonds Psychische Gezondheid
- Investigators
- Jan Van den Bout, Prof. dr., Study director, Utrecht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00513045
- Sponsor's protocol ID
- FPG20066126
- Acronym
- Nightmares
- Status last verified
- Nov 2008
- First submitted
- 7 Aug 2007
- Last updated
- 19 Nov 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Self-Help Method for Nightmares
- ClinicalTrials.gov ID
- NCT00513045
- Acronym / sponsor ID
- Nightmares / FPG20066126
- Conditions
- Nightmares
- Keywords
- Nightmares, treatment, self-help
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 399 participants (actual)
- Lead sponsor
- Utrecht UniversityUniversity, hospital or other
- Collaborators
- Fonds Psychische Gezondheid
- Study start
- Apr 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 8 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to validate a newly designed self-help treatment for nightmares. This self-help treatment is based on Imagery Rehearsal Therapy. This treatment will be validated in comparison to an exposure treatment a diary condition and a waiting list condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| IRT | Experimental | Behavioral: IRTIntervention based on Imagery Rehearsal Therapy |
| Exposure | Active comparator | Behavioral: ExposureTreatment based on exposure |
| Nightmare diary | No intervention | –Recording nightmares in a diary |
| Waiting list | No intervention | –Waiting list |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Suffering from Nightmares
- Access to internet
- A valid e-mail address
- Be able to understand Dutch
Key exclusion criteria (6 listed)
- Severe posttraumatic complaints
- Severe depression
- High anxiety ratings
- In therapy for post traumatic stress disorder
- Being suicidal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IRTCognitive behavior intervention | Behavioural | IRT |
| ExposureExposure intervention | Behavioural | Exposure |
Primary outcome
Nightmare frequency
Time frame: 1 year
Nightmare distress
Time frame: 1 year
5 secondary outcomes
Sleep quality
Time frame: 1 year
Sleep complaints
Time frame: 1 year
Anxiety ratings
Time frame: 1 year
Posttraumatic complaints (low - moderate - high)
Time frame: 1 year
Depression ratings
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2008.
Related trials for Nightmares
Recruiting
NightWare and Cardiovascular Health in Veterans With PTSD
Post-traumatic Stress Disorder (PTSD), Cardiovascular Diseases
Recruiting
Validation of an Algorithm for Predicting Awakenings Associated With Trauma-related Nightmares, Based on the Analysis of Physiological Patterns in Military and Former Military Patients Suffering From Post-traumatic Stress Disorder
PTSD - Post Traumatic Stress Disorder, Trauma-related Nightmares
Active, not recruitingPhase 2
Nightmare Deconstruction and Reprocessing vs. NightWare Wristband
Nightmare
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Active, not recruitingPhase 3
Predicting Responses to PTSD Treatment With Iris and Cardiovascular Tests
Posttraumatic Stress Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Van den Bout, Prof. dr. study director
Utrecht University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IRT and Exposure in people with Nightmares, run by Utrecht University at 1 site 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 4 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 19 Nov 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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?
Nightmare frequency (time frame: 1 year). 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?
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 19 Nov 2008.