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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
122

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Germany
    • Hessen
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Imagery Rehearsal Treatment
Imagery Rehearsal Treatment; 1 session on-site and 4 weeks of individual daily training; following principles Krakow and Zadra (2006)
Behavioral: Imagery Rehearsal Treatment
Imagery Rehearsal Therapy
EXPERIMENTAL: Confrontation
Confrontation with nightmare content, until fear reaction habituates; 1 session on-site and 4 weeks of individual daily training
Behavioral: confrontation
Confrontation
PLACEBO_COMPARATOR: Imagination
Imagination of a safe and pleasant site; 1 session on-site and 4 weeks of individual daily training
Behavioral: imagination
Imagination

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Goethe University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2009

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 8, 2017

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 8, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 14, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2009

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 15, 2009

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 27, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 23, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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