- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00977340
Study on the Psychotherapeutic Treatment of Chronic Nightmares
August 23, 2021 updated by: Regina Steil, Goethe University
Psychotherapeutic Treatment of Chronic Nightmares: Differential Efficacy of Imagery Rehearsal Therapy Compared to Confrontation and Psychotherapeutic Placebo
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The inclusion and exclusion criteria are assessed during a telephone interview.
If the participants meet the criteria, they are randomly assigned to two intervention groups or an active control group.
In the first session the participants who suffer from chronic nightmares are interviewed using the Structured Clinical Interview for DSM-IV (SCID-I and -II) to determine the clinical diagnosis; in addition, they are given questionnaires and record sheets to obtain baseline data.
They are asked to record their nightmares in a "dream diary" up until the next session four weeks later.
At that session they learn one of three interventions to reduce nightmares.
The first group receives imagery rehearsal treatment in which participants learn to consciously alter the contents of their nightmares and then to visualize the new set of images.
The second group is subjected to confrontation treatment in which they are instructed to confront their nightmares until habituation.
The third group, the psychotherapeutic placebo group, just learn an imagination technique, without reference to their nightmares.
At the end of the intervention session all participants receive written instructions on how to perform the learned method at home.
They must also record their dreams up until the next session.
That session and the last one are used for data acquisition.
At these sessions, the participants are asked to fill in the questionnaires given to them at the beginning of the treatment.
Study Type
Interventional
Enrollment (Actual)
122
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Hessen
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Frankfurt/Main, Hessen, Germany, D-60054
- Johann Wolfgang Goethe University - Department of Clinical Psychology and Ppsychotherapy
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Imagery Rehearsal Treatment
Imagery Rehearsal Treatment; 1 session on-site and 4 weeks of individual daily training; following principles Krakow and Zadra (2006)
|
Imagery Rehearsal Therapy
|
|
EXPERIMENTAL: Confrontation
Confrontation with nightmare content, until fear reaction habituates; 1 session on-site and 4 weeks of individual daily training
|
Confrontation
|
|
PLACEBO_COMPARATOR: Imagination
Imagination of a safe and pleasant site; 1 session on-site and 4 weeks of individual daily training
|
Imagination
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
frequency of nightmares
Time Frame: in the first diagnostical session, four weeks after interventional session in addition to follow-up-measurement
|
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
Time Frame: in the first diagnostical session, four weeks after interventional session in addition to follow-up-measurement
|
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
Time Frame: in the first diagnostical session, four weeks after interventional session in addition to follow-up-measurement
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Anxiety
Time Frame: in the first diagnostical session, four weeks after interventional session in addition to follow-up-measurement
|
self rated: Beck Anxiety Inventory: 21 Items to be rated on 0 to 3 scales, range 0 to 63, higher values indicate higher anxiety in both measures rated by therapist on Hamilton Anxiety Scale: 14 Items to be rated on 5-point-scales from "not at all" to "very strong", range 0 to 56
|
in the first diagnostical session, four weeks after interventional session in addition to follow-up-measurement
|
|
Depression
Time Frame: in the first diagnostical session, four weeks after interventional session in addition to follow-up-measurement
|
self rated: Beck Depression Inventory II, 21 Items to be rated on 0 to 3 scales, range 0 to 63 rated by therapist on Hamilton Depression Scale, 21 Items to be rated on 0-2 or 0-4 scales, range 0-66, higher values indicate higher depression in both measures
|
in the first diagnostical session, four weeks after interventional session in addition to follow-up-measurement
|
|
sleep quality
Time Frame: in the first diagnostical session, four weeks after interventional session in addition to follow-up-measurement
|
Landeck Inventory for the Assessment of Sleep Disorders (LISST, Weeß, 2002): This is a screening instrument for sleep disorders, only the item measuring dream recall and the 8-item sleep quality subscale were used.
Both use 6-point Likert scales.
The sleep quality subscale score range is 0 to 40, and higher values indicate lower sleep quality.
|
in the first diagnostical session, four weeks after interventional session in addition to follow-up-measurement
|
|
self efficacy
Time Frame: in the first diagnostical session, four weeks after interventional session in addition to follow-up-measurement
|
Selbstwirksamkeitsskala (General self efficacy, Jerusalem & Schwarzer, 1998) This 10-item measure contains statements such as "I am confident that I could deal efficiently with unexpected events" or "I can usually handle whatever comes my way" rated on 4-point Likert scales.
The scale was used to operationalize mastery.
Its range is 10 to 40, with higher values indicating higher self-efficacy.
|
in the first diagnostical session, four weeks after interventional session in addition to follow-up-measurement
|
|
General psychopathology
Time Frame: in the first diagnostical session, four weeks after interventional session in addition to follow-up-measurement
|
Symptom Checklist 90-R The SCL measures a wide variety of psychopathological symptoms.
The Global Severity Index (GSI) was used.
Its range is 0 to 4, with higher values indicating more and/or more intense symptoms.
|
in the first diagnostical session, four weeks after interventional session in addition to follow-up-measurement
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Regina Steil, PhD, Johann Wolfgang Goethe University - Department of Clinical Psychology and Ppsychotherapy
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
October 1, 2009
Primary Completion (ACTUAL)
November 8, 2017
Study Completion (ACTUAL)
November 8, 2017
Study Registration Dates
First Submitted
September 14, 2009
First Submitted That Met QC Criteria
September 14, 2009
First Posted (ESTIMATE)
September 15, 2009
Study Record Updates
Last Update Posted (ACTUAL)
August 27, 2021
Last Update Submitted That Met QC Criteria
August 23, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- StudieAlptraum1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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