Study on the Psychotherapeutic Treatment of Chronic Nightmares

The recruitment status of this study is unknown because the information has not been verified recently.

Verified September 2009 by Goethe University.
Recruitment status was Not yet recruiting

Sponsor:

Information provided by:

Goethe University

ClinicalTrials.gov Identifier:

NCT00977340

First received: September 14, 2009

Last updated: NA

Last verified: September 2009

History: No changes posted

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
Chronic Nightmares	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

Resource links provided by NLM:

MedlinePlus related topics: Anxiety

U.S. FDA Resources

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 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Imagery Rehearsal Treatment	Behavioral: Imagery Rehearsal Treatment Imagery Rehearsal Therapy
Experimental: confrontation confrontation	Behavioral: confrontation Confrontation
Placebo Comparator: imagination	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
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

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

Sponsors and Collaborators

Goethe University

Investigators

Principal Investigator:

Regina Steil, PhD

Johann Wolfgang Goethe University - Department of Clinical Psychology and Ppsychotherapy

More Information

No publications provided

Responsible Party:	Regina Steil, Johann Wolfgang Goethe University - Department of Clinical Psychology and Ppsychotherapy
ClinicalTrials.gov Identifier:	NCT00977340 History of Changes
Other Study ID Numbers:	StudieAlptraum1
Study First Received:	September 14, 2009
Last Updated:	September 14, 2009
Health Authority:	Germany: Ethics Commission

Keywords provided by Goethe University:

Chronic nightmare sufferers
nightmares
IRT
imagery rehearsal Therapy

sleep disturbance
treatment of nightmares
confrontation
People who suffer of chronic nightmares

Additional relevant MeSH terms:

Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013

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