NCT00977340

Brief Summary

The purpose of this study is to determine whether a change in the content of nightmares is necessary at all in the treatment of chronic nightmares or if a single confrontation with their content is sufficient to reduce nightmare frequency significantly.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
122

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2009

Longer than P75 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 14, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 15, 2009

Completed
16 days until next milestone

Study Start

First participant enrolled

October 1, 2009

Completed
8.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 8, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 8, 2017

Completed
Last Updated

August 27, 2021

Status Verified

August 1, 2021

Enrollment Period

8.1 years

First QC Date

September 14, 2009

Last Update Submit

August 23, 2021

Conditions

Keywords

Chronic nightmare sufferersnightmaresImagery Rehearsal Therapy IRTsleep disturbancetreatment of nightmaresconfrontationPeople who suffer of chronic nightmares

Outcome Measures

Primary Outcomes (3)

  • frequency of nightmares

    Nightmare Frequency Questionnaire (NFQ, Krakow et al., 2000) number of nightmares per week. The participant is asked to state the number of nightmares in the last three months, the response is to be given as an absolute frequency per year, month, or week, whichever is applicable. The range is zero to any number the participant states, the maximum number reported was 20.

    in the first diagnostical session, four weeks after interventional session in addition to follow-up-measurement

  • nightmare effects

    Nightmare Effects Survey (NES, Krakow et al., 2000) The first item asks whether the person's life is generally affected by nightmares. The remaining eleven items list areas in daily life (sleep, work, relationships, daytime energy, school, mood, sex life, diet, mental health, physical health, and leisure activities) rated on 5-point Likert scales regarding how much they are "adversely or negatively affected by nightmares". The range is 0 to 44, and higher values indicate more effects.

    in the first diagnostical session, four weeks after interventional session in addition to follow-up-measurement

  • nightmare distress

    Nightmare Distress Questionnaire (NDQ, Belicki, 1992) The NDQ consists of 13 items rated on 5-point Likert scales. Eleven items pertain to daytime consequences of nightmares (e.g., disliking someone because they were in a nightmare; being afraid to fall asleep for fear of having a nightmare); two items explore interest in professional help and treatment. The range is 13 to 65, and higher values indicate more distress.

    in the first diagnostical session, four weeks after interventional session in addition to follow-up-measurement

Secondary Outcomes (5)

  • Anxiety

    in the first diagnostical session, four weeks after interventional session in addition to follow-up-measurement

  • Depression

    in the first diagnostical session, four weeks after interventional session in addition to follow-up-measurement

  • sleep quality

    in the first diagnostical session, four weeks after interventional session in addition to follow-up-measurement

  • self efficacy

    in the first diagnostical session, four weeks after interventional session in addition to follow-up-measurement

  • General psychopathology

    in the first diagnostical session, four weeks after interventional session in addition to follow-up-measurement

Study Arms (3)

Imagery Rehearsal Treatment

EXPERIMENTAL

Imagery Rehearsal Treatment; 1 session on-site and 4 weeks of individual daily training; following principles Krakow and Zadra (2006)

Behavioral: Imagery Rehearsal Treatment

Confrontation

EXPERIMENTAL

Confrontation with nightmare content, until fear reaction habituates; 1 session on-site and 4 weeks of individual daily training

Behavioral: confrontation

Imagination

PLACEBO COMPARATOR

Imagination of a safe and pleasant site; 1 session on-site and 4 weeks of individual daily training

Behavioral: imagination

Interventions

Imagery Rehearsal Therapy

Imagery Rehearsal Treatment
confrontationBEHAVIORAL

Confrontation

Confrontation
imaginationBEHAVIORAL

Imagination

Imagination

Eligibility Criteria

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

You may qualify if:

  • nightmare frequency of at least one night per week for six month duration
  • stable medication
  • if currently in psychotherapy: no treatment of nightmares
  • Informed consent

You may not qualify if:

  • Life time clinical diagnosis of schizophrenia, schizoaffective disorder or bipolar disorder according to DSM-IV
  • Body mass index \< 17
  • Initiation of nightmares after taking pharmaceuticals
  • Clinical diagnosis of alcohol or drug addiction according to DSM-IV
  • Mental retardation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johann Wolfgang Goethe University - Department of Clinical Psychology and Ppsychotherapy

Frankfurt am Main, Hesse, D-60054, Germany

Location

MeSH Terms

Conditions

Parasomnias

Condition Hierarchy (Ancestors)

Sleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Regina Steil, PhD

    Johann Wolfgang Goethe University - Department of Clinical Psychology and Ppsychotherapy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Scientific director behavior therapy outpatient center

Study Record Dates

First Submitted

September 14, 2009

First Posted

September 15, 2009

Study Start

October 1, 2009

Primary Completion

November 8, 2017

Study Completion

November 8, 2017

Last Updated

August 27, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations