Nightmare DisorderNCT00977340
Study on the Psychotherapeutic Treatment of Chronic Nightmares
A study testing Imagery Rehearsal Treatment, confrontation and imagination in people with Nightmare Disorder, run by Goethe University at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nightmare Disorder
- What is being tested?
- Imagery Rehearsal Treatment, confrontation and imagination
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 122 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2009to 8 Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Johann Wolfgang Goethe University - Department of Clinical Psychology and Ppsychotherapy
Frankfurt am Main, Hesse, D-60054
About this study
Official title: 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.
Read the 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.
- Conditions
- Nightmare Disorder
- Being tested
- Imagery Rehearsal Treatment, confrontation, imagination
- Keywords
- Chronic nightmare sufferers, nightmares, Imagery Rehearsal Therapy IRT, sleep disturbance, treatment of nightmares, confrontation, People who suffer of chronic nightmares
- Medical subject headings
- Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imagery Rehearsal TreatmentBehavioural
Imagery Rehearsal Therapy
confrontationBehavioural
Confrontation
imaginationBehavioural
Imagination
| Study group | Role | What they receive |
|---|---|---|
| Imagery Rehearsal Treatment | Experimental | Imagery Rehearsal Treatment; 1 session on-site and 4 weeks of individual daily training; following principles Krakow and Zadra (2006) Receives: 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 Receives: Behavioral: confrontation |
| Imagination | Placebo comparator | Imagination of a safe and pleasant site; 1 session on-site and 4 weeks of individual daily training Receives: Behavioral: imagination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: in the first diagnostical session, four weeks after interventional session in addition to follow-up-measurement
Secondary outcomes (5)
Anxiety
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
Measured: in the first diagnostical session, four weeks after interventional session in addition to follow-up-measurement
Depression
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
Measured: in the first diagnostical session, four weeks after interventional session in addition to follow-up-measurement
sleep quality
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.
Measured: in the first diagnostical session, four weeks after interventional session in addition to follow-up-measurement
self efficacy
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.
Measured: in the first diagnostical session, four weeks after interventional session in addition to follow-up-measurement
General psychopathology
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.
Measured: in the first diagnostical session, four weeks after interventional session in addition to follow-up-measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2009 (estimated)
- Study startOct 2009
- Primary completion8 Nov 2017
- Study completion8 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nightmare DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Goethe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Regina Steil, Goethe University
- Investigators
- Regina Steil, PhD, Principal investigator, Johann Wolfgang Goethe University - Department of Clinical Psychology and Ppsychotherapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00977340
- Sponsor's protocol ID
- StudieAlptraum1
- Status last verified
- Aug 2021
- First submitted
- 14 Sep 2009
- Last updated
- 27 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychotherapeutic Treatment of Chronic Nightmares: Differential Efficacy of Imagery Rehearsal Therapy Compared to Confrontation and Psychotherapeutic Placebo
- ClinicalTrials.gov ID
- NCT00977340
- Acronym / sponsor ID
- StudieAlptraum1
- Conditions
- Nightmare Disorder
- Keywords
- Chronic nightmare sufferers, nightmares, Imagery Rehearsal Therapy IRT, sleep disturbance, treatment of nightmares, confrontation, People who suffer of chronic nightmares
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Goethe UniversityUniversity, hospital or other
- Study start
- Oct 2009 (actual)
- Primary completion
- 8 Nov 2017 (actual)
- Study completion
- 8 Nov 2017 (actual)
- First posted
- 15 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Imagery Rehearsal Treatment | Experimental | Behavioral: Imagery Rehearsal TreatmentImagery Rehearsal Treatment; 1 session on-site and 4 weeks of individual daily training; following principles Krakow and Zadra (2006) |
| Confrontation | Experimental | Behavioral: confrontationConfrontation with nightmare content, until fear reaction habituates; 1 session on-site and 4 weeks of individual daily training |
| Imagination | Placebo comparator | Behavioral: imaginationImagination of a safe and pleasant site; 1 session on-site and 4 weeks of individual daily training |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Imagery Rehearsal TreatmentImagery Rehearsal Therapy | Behavioural | Imagery Rehearsal Treatment |
| confrontationConfrontation | Behavioural | Confrontation |
| imaginationImagination | Behavioural | Imagination |
Primary outcome
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.
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.
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.
5 secondary outcomes
Anxiety
Time frame: 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
sleep quality
Time frame: 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
General psychopathology
Time frame: in the first diagnostical session, four weeks after interventional session in addition to follow-up-measurement
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Regina Steil, PhD principal investigator
Johann Wolfgang Goethe University - Department of Clinical Psychology and Ppsychotherapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Imagery Rehearsal Treatment, confrontation and imagination in people with Nightmare Disorder, run by Goethe University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
frequency of nightmares (time frame: in the first diagnostical session, four weeks after interventional session in addition to follow-up-measurement). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2021.