Nightmares Clinical Trial
— MARIOfficial title:
MARI - Treatment of Nightmares Via the Internet - a Randomized Controlled Trial
Verified date | May 2014 |
Source | Karolinska Institutet |
Contact | n/a |
Is FDA regulated | No |
Health authority | Sweden: Regional Ethical Review Board |
Study type | Interventional |
This study is a randomized controlled trial (RCT) to evaluate the effect of an internet-based, guided self-help treatment of reoccurring and distressing nightmares. Imagery Rehearsal Therapy (IRT) will be compared to an active control treatment (CONT) and a recording-only group (REG). It is hypothesized that both active treatments will be superior to REG, and that IRT will be superior to CONT.
Status | Completed |
Enrollment | 175 |
Est. completion date | April 2014 |
Est. primary completion date | April 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - have at least one nightmare (including awakening) or unpleasant dream (do not wake up) per week for at least a month. - experience significant discomfort or distress due to nightmares/unpleasant dream. - the content of the nightmares are not only related to a previous trauma. - at least 18 years - speaks, writes and read Swedish - can not foresee any practical barriers to participation. Exclusion Criteria: - only suffers from night terrors and no nightmares according to criteria (a) to (c) - has a high alcohol or drug use assessed by the AUDIT / DUDIT and assessment interview. - somatic or psychiatric problems that are directly contraindicated or seriously hamper the implementation of the treatment (eg, psychotic disorders). - have severe depression, defined as MADRS-S over 30 or suicidal risk judged by more than 4 points on the MADRS-S question 9 or according to the structured telephone assessment. - has a total score over 76 on the IES-R (one standard deviation above the mean for individuals with a diagnosis of PTSD). - is diagnosed with PTSD and can not provide proof that they have a current health care contact regarding PTSD. - suffer from intrusive images or flashbacks during their waking hours (regardless of a PTSD diagnosis). - currently undergoing some form of treatment that focuses on reducing symptoms of nightmares. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Sweden | Internetpsykiatrienehten (Internet Psychiatry Unit), Psykiatri Sydväst, SLSO | Stockholm |
Lead Sponsor | Collaborator |
---|---|
Karolinska Institutet | Stockholm County Council, Sweden |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in nightmare frequency and distress | Change (from baseline) of nightmare frequency and distress according to daily registrations | 6 weeks (Post) and 16 months (FU) | No |
Secondary | Change (from baseline) in Nightmare Distress self-report | Self-report of nightmare frequency and distress during last 14 days | 6 weeks (Post) and 16 months (FU) | No |
Secondary | Change (from baseline) in IES_R | Impact of Events Scale, self-report to measure PTSD-symptoms | 6 weeks (Post) and 16 months (FU) | No |
Secondary | Change (from baseline) in ISI | Insomni Severity Index, self-report to measure Insomnia symptoms | 6 weeks (Post) and 16 months (FU) | No |
Secondary | Change (from baseline) in MADRS-S | Montgomery and Asberg Depressions Rating Scale - Self Report, to measure level of depression | 6 weeks (Post) and 16 months (FU) | No |
Secondary | Change (from baseline) in HADS | Hospital Ancxiety and Depression Scale, self rating to measure anxiety and depression | 6 weeks (Post) and 16 months (FU) | No |
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