NightmaresPhase 3MARINCT01502930
Treatment of Nightmares Via the Internet
A Phase 3 study testing IRT and Stress Reduction in people with Nightmares, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nightmares
- What is being tested?
- IRT and Stress Reduction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2012to Apr 2014
- Phase
- Phase 3
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Internetpsykiatrienehten (Internet Psychiatry Unit), Psykiatri Sydväst, SLSO
Stockholm
About this study
Official title: MARI - Treatment of Nightmares Via the Internet - a Randomized Controlled Trial
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.
Read the detailed description
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).
- Conditions
- Nightmares
- Being tested
- IRT, Stress Reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IRTBehavioural
Internet-based IRT with therapist support during 6 weeks
Stress ReductionBehavioural
Internet-based stress reduction with therapist support during 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| IRT | Experimental | Imagery Rehearsal Therapy Receives: Behavioral: IRT |
| CONT | Active comparator | Stress reduction and positive imagery Receives: Behavioral: Stress Reduction |
| REG | No intervention | Registration only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in nightmare frequency and distress
Change (from baseline) of nightmare frequency and distress according to daily registrations
Measured: 6 weeks (Post) and 16 months (FU)
Secondary outcomes (5)
Change (from baseline) in Nightmare Distress self-report
Self-report of nightmare frequency and distress during last 14 days
Measured: 6 weeks (Post) and 16 months (FU)
Change (from baseline) in IES_R
Impact of Events Scale, self-report to measure PTSD-symptoms
Measured: 6 weeks (Post) and 16 months (FU)
Change (from baseline) in ISI
Insomni Severity Index, self-report to measure Insomnia symptoms
Measured: 6 weeks (Post) and 16 months (FU)
Change (from baseline) in MADRS-S
Montgomery and Asberg Depressions Rating Scale - Self Report, to measure level of depression
Measured: 6 weeks (Post) and 16 months (FU)
Change (from baseline) in HADS
Hospital Ancxiety and Depression Scale, self rating to measure anxiety and depression
Measured: 6 weeks (Post) and 16 months (FU)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionApr 2014
- Study completionApr 2014
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.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm
- Responsible party
- Principal investigator, Viktor Kaldo, Karolinska Institutet
- Investigators
- Viktor Kaldo, Ph.D, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01502930
- Sponsor's protocol ID
- ICBT_Nightmares
- Acronym
- MARI
- Status last verified
- May 2014
- First submitted
- 22 Dec 2011
- Last updated
- 16 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MARI - Treatment of Nightmares Via the Internet - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01502930
- Acronym / sponsor ID
- MARI / ICBT_Nightmares
- Conditions
- Nightmares
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Region Stockholm
- Study start
- Jan 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 2 Jan 2012 (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.
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.
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IRT | Experimental | Behavioral: IRTImagery Rehearsal Therapy |
| CONT | Active comparator | Behavioral: Stress ReductionStress reduction and positive imagery |
| REG | No intervention | –Registration only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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).
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 |
|---|---|---|
| IRTInternet-based IRT with therapist support during 6 weeks | Behavioural | IRT |
| Stress ReductionInternet-based stress reduction with therapist support during 6 weeks | Behavioural | CONT |
Primary outcome
Change in nightmare frequency and distress
Time frame: 6 weeks (Post) and 16 months (FU)
Change (from baseline) of nightmare frequency and distress according to daily registrations
5 secondary outcomes
Change (from baseline) in Nightmare Distress self-report
Time frame: 6 weeks (Post) and 16 months (FU)
Change (from baseline) in IES_R
Time frame: 6 weeks (Post) and 16 months (FU)
Change (from baseline) in ISI
Time frame: 6 weeks (Post) and 16 months (FU)
Change (from baseline) in MADRS-S
Time frame: 6 weeks (Post) and 16 months (FU)
Change (from baseline) in HADS
Time frame: 6 weeks (Post) and 16 months (FU)
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 16 May 2014.
- The public page of the Internet-CBT treatment platformLink provided by the sponsor.
Related trials for Nightmares
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Recruiting
Restorative Early Sleep Treatment After the Emergency Department
Insomnia, Nightmares Associated With Trauma and Stress
Recruiting
NightWare and Cardiovascular Health in Veterans With PTSD
Post-traumatic Stress Disorder (PTSD), Cardiovascular Diseases
Active, not recruitingPhase 2
Nightmare Deconstruction and Reprocessing vs. NightWare Wristband
Nightmare
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.
Viktor Kaldo, Ph.D principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing IRT and Stress Reduction in people with Nightmares, run by Karolinska Institutet at 1 site in Sweden.
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 6 inclusion and 8 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 16 May 2014. 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 Sweden. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in nightmare frequency and distress (time frame: 6 weeks (Post) and 16 months (FU)). 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 16 May 2014.