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Completed

NCT Number: NCT00977340

Study on the Psychotherapeutic Treatment of Chronic Nightmares

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johann Wolfgang Goethe University - Department of Clinical Psychology and Ppsychotherapy

Frankfurt am Main, Hesse, D-60054, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Imagery Rehearsal Treatment

Behavioral

Imagery Rehearsal Therapy

confrontation

Behavioral

Confrontation

imagination

Behavioral

Imagination

Primary outcomes

  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. 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.

  2. 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.

  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) 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.

Secondary outcomes

  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: 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

  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, 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

  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): 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.

  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) 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.

  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 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.

Sponsors and collaborators

Lead sponsor

Goethe University

Other

Registry information

Official study title

Psychotherapeutic Treatment of Chronic Nightmares: Differential Efficacy of Imagery Rehearsal Therapy Compared to Confrontation and Psychotherapeutic Placebo

Important dates

Study start
2009
Primary completion
2017
Study completion
2017
First posted
Sep 15, 2009
Registry last updated
Aug 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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