NCT01502930

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
175

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2011

Completed
10 days until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 2, 2012

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

May 16, 2014

Status Verified

May 1, 2014

Enrollment Period

2.2 years

First QC Date

December 22, 2011

Last Update Submit

May 15, 2014

Conditions

Nightmares

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (5)

  • Change (from baseline) in Nightmare Distress self-report

    6 weeks (Post) and 16 months (FU)

  • Change (from baseline) in IES_R

    6 weeks (Post) and 16 months (FU)

  • Change (from baseline) in ISI

    6 weeks (Post) and 16 months (FU)

  • Change (from baseline) in MADRS-S

    6 weeks (Post) and 16 months (FU)

  • Change (from baseline) in HADS

    6 weeks (Post) and 16 months (FU)

Study Arms (3)

IRT

EXPERIMENTAL

Imagery Rehearsal Therapy

Behavioral: IRT

CONT

ACTIVE COMPARATOR

Stress reduction and positive imagery

Behavioral: Stress Reduction

REG

NO INTERVENTION

Registration only

Interventions

IRTBEHAVIORAL

Internet-based IRT with therapist support during 6 weeks

IRT
Stress ReductionBEHAVIORAL

Internet-based stress reduction with therapist support during 6 weeks

CONT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Internetpsykiatrienehten (Internet Psychiatry Unit), Psykiatri Sydväst, SLSO

Stockholm, Sweden

Location

Related Links

MeSH Terms

Interventions

Mindfulness-Based Stress Reduction

Intervention Hierarchy (Ancestors)

MindfulnessCognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Viktor Kaldo, Ph.D

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 22, 2011

First Posted

January 2, 2012

Study Start

January 1, 2012

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

May 16, 2014

Record last verified: 2014-05

Locations

SE(1)