Internetpsykiatrienehten (Internet Psychiatry Unit), Psykiatri Sydväst, SLSO
Stockholm, Sweden
NCT Number: NCT01502930
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 3
Stockholm, Sweden
Nightmares are distressing or frightening dreams, affecting 2.4 to 5% of the population. Suffering consists of disturbed sleep, fear and distress during night and/or day, expectancy anxiety and impaired functioning during the day.
Various forms of Cognitive Behavior Therapy (CBT) has been previously shown to be effective against nightmares and among them Imagery Rehearsal Therapy (IRT) has been the most promising. IRT consists of approaching the unpleasant dreams and to imagine a positive ending to them. So far IRT has been compared to untreated controls or treatments that have included methods to some extent similar to those in IRT, and it is therefore difficult to determine the specific effect of IRT.
Since access to CBT therapists is low, different types of self-help treatments for nightmares have been tested, but often these therapies have been provided without the assistance of a therapist, a procedure known to usually lower the effect of self-help treatments. So far, no nightmare treatment has been conducted over the Internet.
IRT will in this study be given as Internet CBT (ICBT) and will be compared to an active and credible control treatment (CONT) consisting of relaxation and exercise to focus on positive images or dreams, but without approaching or reinterpreting the nightmares. Relaxation Training has previously shown preliminary positive effects on nightmares. Both active treatments will be compared to a waiting list which only records how they manage their nightmares (REG).
The main purpose of this study is to examine whether the positive effects of IRT that has been seen in previous studies persists even when IRT is compared with a credible, active control treatment that does not contain the presumed active parts of the IRT. In addition, an untreated control group is used to ensure that the effects are not only due to spontaneous improvement. The control group will afterwards be treated with IRT without therapist support, in order to make a preliminary evaluation of the importance of therapist support.
Some researchers argue that nightmares are not to be seen only as something that is often caused or is a side effect of other conditions, but as a separate problem that should receive special treatment. Our study will help to determine whether it is possible to treat nightmares also in people with other problems such as posttraumatic stress disorder (PTSD).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Internet-based IRT with therapist support during 6 weeks
Internet-based stress reduction with therapist support during 6 weeks
Time frame: 6 weeks (Post) and 16 months (FU)
Change (from baseline) of nightmare frequency and distress according to daily registrations
Time frame: 6 weeks (Post) and 16 months (FU)
Self-report of nightmare frequency and distress during last 14 days
Time frame: 6 weeks (Post) and 16 months (FU)
Impact of Events Scale, self-report to measure PTSD-symptoms
Time frame: 6 weeks (Post) and 16 months (FU)
Insomni Severity Index, self-report to measure Insomnia symptoms
Time frame: 6 weeks (Post) and 16 months (FU)
Montgomery and Asberg Depressions Rating Scale - Self Report, to measure level of depression
Time frame: 6 weeks (Post) and 16 months (FU)
Hospital Ancxiety and Depression Scale, self rating to measure anxiety and depression
Karolinska Institutet
Other
MARI - Treatment of Nightmares Via the Internet - a Randomized Controlled Trial
Acronym: MARI
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