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Study on the Psychotherapeutic Treatment of Chronic Nightmares

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2016 by Goethe University
Sponsor:
Information provided by (Responsible Party):
Regina Steil, Goethe University
ClinicalTrials.gov Identifier:
NCT00977340
First received: September 14, 2009
Last updated: April 27, 2016
Last verified: April 2016
  Purpose
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 Intervention
Nightmare Disorder
Behavioral: Imagery Rehearsal Treatment
Behavioral: confrontation
Behavioral: imagination

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Psychotherapeutic Treatment of Chronic Nightmares: Differential Efficacy of Imagery Rehearsal Therapy Compared to Confrontation and Psychotherapeutic Placebo

Further study details as provided by Goethe University:

Primary Outcome Measures:
  • frequency of nightmares [ Time Frame: in the first diagnostical session, four weeks after interventional session in addition to follow-up-measurement ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Anxiety [ Time Frame: in the first diagnostical session, four weeks after interventional session in addition to follow-up-measurement ] [ Designated as safety issue: No ]
  • Depression [ Time Frame: in the first diagnostical session, four weeks after interventional session in addition to follow-up-measurement ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • nightmare effect survey (Krakow) [ Time Frame: in the first diagnostical session, four weeks after interventional session in addition to follow-up-measurement ] [ Designated as safety issue: No ]
  • nightmare distress questionnaire (Belicki) [ Time Frame: in the first diagnostical session, four weeks after interventional session in addition to follow-up-measurement ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: October 2009
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00977340

Contacts
Contact: Regina Steil, PhD +49 69/798 23379 steil@psych.uni-frankfurt.de
Contact: Ulrich Stangier, Prof. +49 151/177 542 01 stangier@psych.uni-frankfurt.de

Locations
Germany
Johann Wolfgang Goethe University - Department of Clinical Psychology and Ppsychotherapy Not yet recruiting
Frankfurt/Main, Hessen, Germany, D-60054
Contact: Regina Steil, PhD    +49 69/798 23379      
Contact: Ulrich Stangier, Prof.    +49 151/177 542 01      
Principal Investigator: Regina Steil, PhD         
Johann Wolfgang Goethe University - Department of Clinical Psychology and Ppsychotherapy Recruiting
Frankfurt/Main, Hessen, Germany, D-60054
Contact: Regina Steil, PhD    +49 69/798 23379      
Contact: Ulrich Stangier, Prof.    +49 151/177 542 01      
Principal Investigator: Regina Steil, PhD         
Sponsors and Collaborators
Goethe University
Investigators
Principal Investigator: Regina Steil, PhD Johann Wolfgang Goethe University - Department of Clinical Psychology and Ppsychotherapy
  More Information

Responsible Party: Regina Steil, Scientific director behavior therapy outpatient center, Goethe University
ClinicalTrials.gov Identifier: NCT00977340     History of Changes
Other Study ID Numbers: StudieAlptraum1 
Study First Received: September 14, 2009
Last Updated: April 27, 2016
Health Authority: Germany: Ethics Commission
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by 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:
Psychotropic Drugs

ClinicalTrials.gov processed this record on September 26, 2016