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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

Tracking Information
First Submitted Date  ICMJE September 14, 2009
First Posted Date  ICMJE September 15, 2009
Last Update Posted Date July 2, 2018
Actual Study Start Date  ICMJE October 2009
Actual Primary Completion Date November 8, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 28, 2018)
  • 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
  • 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)
  • 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)
Original Primary Outcome Measures  ICMJE
 (submitted: September 14, 2009)
frequency of nightmares [ Time Frame: in the first diagnostical session, four weeks after interventional session in addition to follow-up-measurement ]
Change History Complete list of historical versions of study NCT00977340 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 28, 2018)
  • 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
  • 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
  • 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
  • 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)
  • General psychopathology [ Time Frame: in the first diagnostical session, four weeks after interventional session in addition to follow-up-measurement ]
    Symptom Checklist 90-R
Original Secondary Outcome Measures  ICMJE
 (submitted: September 14, 2009)
  • 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 (LISST-Landecker Survey of Sleep Quality) [ Time Frame: in the first diagnostical session, four weeks after interventional session in addition to follow-up-measurement ]
  • self efficacy (General self efficacy, Jerusalem & Schwarzer) [ Time Frame: in the first diagnostical session, four weeks after interventional session in addition to follow-up-measurement ]
  • nightmare effect survey (Krakow) [ Time Frame: in the first diagnostical session, four weeks after interventional session in addition to follow-up-measurement ]
  • nightmare distress questionnaire (Belicki) [ Time Frame: in the first diagnostical session, four weeks after interventional session in addition to follow-up-measurement ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study on the Psychotherapeutic Treatment of Chronic Nightmares
Official Title  ICMJE Psychotherapeutic Treatment of Chronic Nightmares: Differential Efficacy of Imagery Rehearsal Therapy Compared to Confrontation and Psychotherapeutic Placebo
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Nightmare Disorder
Intervention  ICMJE
  • Behavioral: Imagery Rehearsal Treatment
    Imagery Rehearsal Therapy
  • Behavioral: confrontation
    Confrontation
  • Behavioral: imagination
    Imagination
Study Arms  ICMJE
  • Experimental: Imagery Rehearsal Treatment
    Imagery Rehearsal Treatment; 1 session on-site and 4 weeks of individual daily training; following principles Krakow and Zadra (2006)
    Intervention: Behavioral: Imagery Rehearsal Treatment
  • Experimental: Confrontation
    Confrontation with nightmare content, until fear reaction habituates; 1 session on-site and 4 weeks of individual daily training
    Intervention: Behavioral: confrontation
  • Placebo Comparator: Imagination
    Imagination of a safe and pleasant site; 1 session on-site and 4 weeks of individual daily training
    Intervention: Behavioral: imagination
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 28, 2018)
122
Original Estimated Enrollment  ICMJE
 (submitted: September 14, 2009)
90
Actual Study Completion Date  ICMJE November 8, 2017
Actual Primary Completion Date November 8, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00977340
Other Study ID Numbers  ICMJE StudieAlptraum1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Regina Steil, Goethe University
Study Sponsor  ICMJE Goethe University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Regina Steil, PhD Johann Wolfgang Goethe University - Department of Clinical Psychology and Ppsychotherapy
PRS Account Goethe University
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP