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Study on the Psychotherapeutic Treatment of Chronic Nightmares

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ClinicalTrials.gov Identifier: NCT00977340
Recruitment Status : Completed
First Posted : September 15, 2009
Last Update Posted : July 2, 2018
Sponsor:
Information provided by (Responsible Party):
Regina Steil, Goethe University

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.

Condition or disease Intervention/treatment Phase
Nightmare Disorder Behavioral: Imagery Rehearsal Treatment Behavioral: confrontation Behavioral: imagination Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 122 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Psychotherapeutic Treatment of Chronic Nightmares: Differential Efficacy of Imagery Rehearsal Therapy Compared to Confrontation and Psychotherapeutic Placebo
Actual Study Start Date : October 2009
Actual Primary Completion Date : November 8, 2017
Actual Study Completion Date : November 8, 2017

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)
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




Primary Outcome Measures :
  1. 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

  2. nightmare distress [ 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)

  3. 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)


Secondary Outcome Measures :
  1. Anxiety [ Time Frame: in the first diagnostical session, four weeks after interventional session in addition to follow-up-measurement ]
    self rated: Beck Anxiety Inventory rated by therapist on Hamilton Anxiety Scale

  2. 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 rated by therapist on Hamilton Depression Scale

  3. 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), especially quality of sleep-scale

  4. 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)

  5. General psychopathology [ Time Frame: in the first diagnostical session, four weeks after interventional session in addition to follow-up-measurement ]
    Symptom Checklist 90-R



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00977340


Locations
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Germany
Johann Wolfgang Goethe University - Department of Clinical Psychology and Ppsychotherapy
Frankfurt/Main, Hessen, Germany, D-60054
Sponsors and Collaborators
Goethe University
Investigators
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Principal Investigator: Regina Steil, PhD Johann Wolfgang Goethe University - Department of Clinical Psychology and Ppsychotherapy

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Responsible Party: Regina Steil, Scientific director behavior therapy outpatient center, Goethe University
ClinicalTrials.gov Identifier: NCT00977340     History of Changes
Other Study ID Numbers: StudieAlptraum1
First Posted: September 15, 2009    Key Record Dates
Last Update Posted: July 2, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Regina Steil, Goethe University:
Chronic nightmare sufferers
nightmares
Imagery Rehearsal Therapy IRT
sleep disturbance
treatment of nightmares
confrontation
People who suffer of chronic nightmares
Additional relevant MeSH terms:
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Psychotropic Drugs