Treatment of Nightmares Via the Internet

Nightmares Clinical Trial

— MARI  

Official title:

MARI - Treatment of Nightmares Via the Internet - a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01502930
• Other study ID #: ICBT_Nightmares
• Status: Completed
• Phase: Phase 3
• First received: December 22, 2011
• Last updated: May 15, 2014
• Start date: January 2012
• Est. completion date: April 2014

Study information

• Verified date: May 2014
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical 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). It is hypothesized that both active treatments will be superior to REG, and that IRT will be superior to CONT.

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).

Recruitment information / eligibility

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nightmares

Intervention

Behavioral:
• IRT
Internet-based IRT with therapist support during 6 weeks
• Stress Reduction
Internet-based stress reduction with therapist support during 6 weeks

Locations

Country	Name	City	State
Sweden	Internetpsykiatrienehten (Internet Psychiatry Unit), Psykiatri Sydväst, SLSO	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Stockholm County Council, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

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

External Links

•   The public page of the Internet-CBT treatment platform