Study on the Psychotherapeutic Treatment of Chronic Nightmares
Psychotherapeutic Treatment of Chronic Nightmares: Differential Efficacy of Imagery Rehearsal Therapy Compared to Confrontation and Psychotherapeutic Placebo
1 other identifier
interventional
122
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2009
Longer than P75 for not_applicable
1 active site
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
CompletedFirst Posted
Study publicly available on registry
September 15, 2009
CompletedStudy Start
First participant enrolled
October 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 8, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 8, 2017
CompletedAugust 27, 2021
August 1, 2021
8.1 years
September 14, 2009
August 23, 2021
Conditions
Keywords
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
EXPERIMENTALImagery Rehearsal Treatment; 1 session on-site and 4 weeks of individual daily training; following principles Krakow and Zadra (2006)
Confrontation
EXPERIMENTALConfrontation with nightmare content, until fear reaction habituates; 1 session on-site and 4 weeks of individual daily training
Imagination
PLACEBO COMPARATORImagination of a safe and pleasant site; 1 session on-site and 4 weeks of individual daily training
Interventions
Eligibility Criteria
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Regina Steil, PhD
Johann Wolfgang Goethe University - Department of Clinical Psychology and Ppsychotherapy
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