Nightmares Clinical Trial
— NightmaresOfficial title:
A Self-Help Method for Nightmares
| Verified date | November 2008 |
| Source | Utrecht University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Netherlands: Medical Ethics Review Committee (METC) |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 399 |
| Est. completion date | November 2008 |
| Est. primary completion date | September 2008 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Suffering from Nightmares - Access to internet - A valid e-mail address - Be able to understand Dutch Exclusion Criteria: - Severe posttraumatic complaints - Severe depression - High anxiety ratings - In therapy for post traumatic stress disorder - Being suicidal - Schizophrenic or having a psychosis episode |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Netherlands | Utrecht University | Utrecht |
| Lead Sponsor | Collaborator |
|---|---|
| Utrecht University | Fonds Psychische Gezondheid |
Netherlands,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Nightmare frequency | 1 year | No | |
| Primary | Nightmare distress | 1 year | No | |
| Secondary | Sleep quality | 1 year | No | |
| Secondary | Sleep complaints | 1 year | No | |
| Secondary | Anxiety ratings | 1 year | No | |
| Secondary | Posttraumatic complaints (low - moderate - high) | 1 year | No | |
| Secondary | Depression ratings | 1 year | No |
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