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Psychiatric Inpatient Nightmare Treatment (PINIT)

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ClinicalTrials.gov Identifier: NCT04198142
Recruitment Status : Recruiting
First Posted : December 13, 2019
Last Update Posted : December 13, 2019
Sponsor:
Collaborators:
Swiss National Science Foundation
Psychiatric University Hospital, Zurich
Information provided by (Responsible Party):
University of Zurich

Brief Summary:
Nightmares are repeated extremely dysphoric and well-remembered dreams, which typically occur during REM sleep in the second half of sleep, may awaken the dreamer, and upon awakening, individuals quickly become oriented and conscious of their surroundings. Nightmares are very common in psychiatric populations. In psychiatric populations, nightmares can occur as a freestanding disorder, persist in patients after undergoing treatment for a psychiatric disorder, and function as a risk and exacerbating factor regarding psychiatric symptoms. Imagery Rehearsal Therapy (IRT) is a cognitive-behavioral-oriented treatment for nightmares and asks patients to identify an especially distressing nightmare and then works together with the patient on changing the nightmare to a more positive theme, story line, or ending. The new contents are then rehearsed using imagery techniques. IRT is often recommended by guidelines. However, IRT has not been investigated in a randomized controlled trial in the population of psychiatric inpatients. In this study, sixty inpatients with nightmares will be recruited from the inpatient units of the Psychiatric University Hospital Zurich (PUK). Participants will be randomly assigned to an Imagery Rehearsal Therapy (IRT) group or a Treatment As Usual (TAU) control group. Questionnaires and dream diaries will measure changes in nightmare frequency, nightmare distress, nightmare effects, nightmare content, overall sleep quality, dream experiences and believes, symptom severity of primary psychiatric diagnoses, and psychotherapy motivation and hopefulness one week and two weeks after one IRT or TAU session. The TAU group will receive a session in which potential problems with the dream diary will be discussed. Patients in the IRT group will be instructed to use imagery exercises with the new dream narrative for 10 to 15 minutes a day for the duration of the study period.

Condition or disease Intervention/treatment Phase
Nightmare Psychiatric Disorder Behavioral: Imagery Rehearsal Therapy Behavioral: Treatment as Usual with dream diaries Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Nightmares in Psychiatric Inpatients With Imagery Rehearsal Therapy: A Randomized Controlled Trial
Actual Study Start Date : November 18, 2019
Estimated Primary Completion Date : May 31, 2020
Estimated Study Completion Date : May 31, 2020

Arm Intervention/treatment
Experimental: Imagery Rehearsal Therapy Intervention
This group receives one to two sessions of Imagery Rehearsal Therapy.
Behavioral: Imagery Rehearsal Therapy

The Imagery Rehearsal Therapy (IRT) intervention used in this study is a short version of the treatment, consisting of 1-2 sessions.

The protocol starts with a very brief explanation of the treatment. Then the patient will be guided through an imagery exercise. The next step is to choose a nightmare. This nightmare is then rescripted to a new narrative, which is in no way distressing to the patient anymore. Subsequently, the therapist will guide the patient through an imagery exercise with the new narrative. The new narrative is then either written down or recorded. Lastly, the therapist will explain to the patient, that he or she should rehearse the new narrative daily with imagery exercises.


Active Comparator: Treatment as Usual with dream diaries
This group receives the usual inpatient care without additional Imagery Rehearsal Therapy sessions, but also keeps dream diaries.
Behavioral: Treatment as Usual with dream diaries
Treatment as Usual means that patients in this arm will receive usual inpatient care. Additionally, they will keep a dream diary. It has been shown in previous studies that keeping a dream diary has a positive effect on nightmares.




Primary Outcome Measures :
  1. Nightmare frequency (change from baseline to 1 and 2 weeks after intervention) [ Time Frame: Baseline, 2 weeks, 3 weeks ]
    The Nightmare Frequency Questionnaire and a dream diary will measure the number of nightmares for each night and for each week.

  2. Nightmare distress (change from baseline to 1 and 2 weeks after intervention) [ Time Frame: Baseline, 2 weeks, 3 weeks ]
    The Nightmare Distress Questionnaire and a dream diary will measure the amount of waking distress associated with nightmares for each night and for each week. Higher Nightmare Distress Questionnaire scores indicate higher nightmare distress (minimum value: 0, maximum value: 52).

  3. Nightmare Intensity (change from baseline to 1 and 2 weeks after intervention) [ Time Frame: Baseline, 2 weeks, 3 weeks ]
    An adapted version of the Mannheim Dream Questionnaire and a dream diary will measure the intensity of the nightmares of a person (waking up from the nightmare, emotional intensity during the nightmare, how clearly patients remember the nightmare after waking up) for each night and for each week.


Secondary Outcome Measures :
  1. Dream experiences and believes (change from baseline to 1 and 2 weeks after intervention) [ Time Frame: Baseline, 2 weeks, 3 weeks, 4 weeks ]
    The Mannheim Dream Questionnaire will measure recall of dreams and nightmares, different dream types (nightmares, lucid dreaming), attitude towards dreaming, what dreamers do with their dreams (telling the dream, recording the dream), and effects of dreams on waking life (creative dreams, problem solving dreams, déjà vu experiences based on dreams) for each week.

  2. Overall sleep quality (change from baseline to 1 and 2 weeks after intervention) [ Time Frame: Baseline, 2 weeks, 3 weeks, 4 weeks ]
    The Pittsburgh Sleep Quality Index as well as a dream diary will measure the quality of a person's sleep for each night and each week. Higher Pittsburgh Sleep Quality Index scores indicate worse sleep quality (minimum value: 0, maximum value: 21).

  3. Nightmare effects (change from baseline to 1 and 2 weeks after intervention) [ Time Frame: Baseline, 2 weeks, 3 weeks, 4 weeks ]
    The Nightmare Effects Survey will measure negative consequences of nightmares on different spheres of life (sleep, work, relationships, daytime energy, school, mood, sex life, diet, mental health, physical health, leisure activities) for each week. Higher Nightmare Effects Survey scores indicate a higher effect of nightmares on daily life (minimum value: 0, maximum value: 44).

  4. Nightmare content (change from baseline to 1 and 2 weeks after intervention) [ Time Frame: Baseline, 2 weeks, 3 weeks, 4 weeks ]
    The Mannheim Dream Questionnaire and a dream diary will measure the qualitative content of each nightmare during a subject's participation period.

  5. Severity of depressive symptoms (change from baseline to 1 and 2 weeks after intervention) [ Time Frame: Baseline, 2 weeks, 3 weeks, 4 weeks ]
    The Beck Depression Inventory will measure current severity of depressive symptoms (minimum value: 0, maximum value: 63). Higher scores indicate a higher severity.

  6. Severity of anxiety symptoms (change from baseline to 1 and 2 weeks after intervention) [ Time Frame: Baseline, 2 weeks, 3 weeks, 4 weeks ]
    The Beck Anxiety Inventory will measure current severity of anxiety symptoms (minimum value: 0, maximum value: 63). Higher scores indicate a higher severity.

  7. Severity of alcohol use (change from baseline to 1 and 2 weeks after intervention) [ Time Frame: Baseline, 2 weeks, 3 weeks, 4 weeks ]
    The Alcohol Use Disorders Identification Test will measure current severity of alcohol use (minimum value: 0, maximum value: 40). Higher scores indicate a higher severity.

  8. Severity of drug use (change from baseline to 1 and 2 weeks after intervention) [ Time Frame: Baseline, 2 weeks, 3 weeks, 4 weeks ]
    The Drug Use Disorders Identification Test will measure current severity of drug use (minimum value: 0, maximum value: 44). Higher scores indicate a higher severity.

  9. Severity of PTSD symptoms (change from baseline to 1 and 2 weeks after intervention) [ Time Frame: Baseline, 2 weeks, 3 weeks, 4 weeks ]
    The PTSD Checklist for DSM-5 will measure current severity of PTSD symptoms (minimum value: 0, maximum value: 80). Higher scores indicate a higher severity.

  10. Severity of psychotic symptoms (change from baseline to 1 and 2 weeks after intervention) [ Time Frame: Baseline, 2 weeks, 3 weeks, 4 weeks ]
    The Community Assessment of Psychic Experiences will measure current severity of psychotic symptoms (frequency and distress score with minimum value: 0, maximum value: 126). Higher scores indicate a higher severity.

  11. Severity of schizophrenia symptoms (change from baseline to 1 and 2 weeks after intervention) [ Time Frame: Baseline, 2 weeks, 3 weeks, 4 weeks ]
    The Positive and Negative Syndrom Scale will measure current severity of schizophrenia symptoms (minimum value: 30, maximum value: 210). Higher scores indicate a higher severity.


Other Outcome Measures:
  1. Demographic and personal information [ Time Frame: Baseline ]
    A questionnaire will measure demographic and medical background information, such as sex, age, nationality, marital status, residence permit status, children, life situation, highest education, current or last work situation, current social situation, socioeconomic status.

  2. Primary psychiatric diagnosis [ Time Frame: Baseline ]
    The Mini International Neuropsychiatric Interview is a diagnostic interview, which will measure, which psychiatric diagnosis / diagnoses are met according to the International Classification of Diseases (ICD-10) and the Diagnostic and Statistical Manual of Mental Disorders (DSM 4).

  3. Current medication [ Time Frame: Baseline, 2 weeks, 3 weeks, 4 weeks ]
    A medication protocol will document current medication.

  4. Frequency of imagery exercises during the study participation [ Time Frame: Baseline, 2 weeks, 3 weeks, 4 weeks ]
    A questionnaire and a dream diary will ask participants in the IRT group if they did their daily imagery exercises for each day and for the whole study period.

  5. Duration of imagery exercises during the study participation [ Time Frame: Baseline, 2 weeks, 3 weeks, 4 weeks ]
    A questionnaire and a dream diary will ask participants in the IRT group for how long they did their daily imagery exercises for each day and for the whole study period.

  6. Characteristics of the imagery rescription session: Trauma relation of the rescripted nightmare [ Time Frame: 1 week after baseline ]
    A questionnaire, which will be filled out by the therapist during the IRT session, will measure whether the rescripted nightmare is related to a traumatic experience or other aversive life events.

  7. Characteristics of the imagery rescription session: Similarity of the new narrative to the rescripted nightmare [ Time Frame: 1 week after baseline ]
    A questionnaire, which will be filled out by the therapist during the IRT session, will measure how similar the new narrative is to the rescripted nightmare.

  8. Characteristics of the imagery rescription session: Exposure to rescripted nightmare [ Time Frame: 1 week after baseline ]
    A questionnaire, which will be filled out by the therapist during the IRT session, will measure the amount of exposure to the nightmare during the session.

  9. Characteristics of the imagery rescription session: Support by the therapist [ Time Frame: 1 week after baseline ]
    A questionnaire, which will be filled out by the therapist during the IRT session, will measure the amount of support provided by the therapist during the session.

  10. Characteristics of the imagery rescription session: Emotional intensity of the nightmare [ Time Frame: 1 week after baseline ]
    Patients will be asked to rate the emotional intensity of the rescripted nightmare on a scale from 1 to 9.

  11. Characteristics of the imagery rescription session: Emotional intensity of the new narrative [ Time Frame: 1 week after baseline ]
    Patients will be asked to rate the emotional intensity of the rescripted nightmare on a scale from 1 to 9.

  12. Psychotherapy motivation and hopefulness (change from baseline to 1 and 2 weeks after intervention) [ Time Frame: Baseline, 2 weeks, 3 weeks, 4 weeks ]
    The Patient Questionnaire on Therapy Expectation and Evaluation will measure psychotherapy motivation, treatment fit as well as hopefulness of patients regarding their general psychotherapy for each week. Higher scores indicate higher psychotherapy motivation (minimum value: 11, maximum value: 55).



Information from the National Library of Medicine

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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:

  • Male and female patients from the inpatient units at the Psychiatric University Hospital Zurich (PUK) between 18 and 65
  • Self-reporting nightmares causing sleep disruption or significant emotional distress
  • Currently receiving inpatient care at the PUK
  • Fluent in German and able to understand the instructions

Exclusion Criteria:

  • No self-reporting nightmares causing sleep disruption or significant emotional distress
  • Psychotherapy for nightmare symptoms specifically, currently or in the preceding 12 months
  • Not able or willing to engage in imagery exercises
  • Patients with a one on one or 15- / 30-minute visual control by the nursing personnel because of risk of suicidal tendencies or the risk of harming others
  • Head injury
  • Cognitive impairment or other severe symptoms that would interfere with understanding instructions and questionnaires or participation in the study
  • Neurological disease
  • Shift work
  • Trouble speaking and / or understanding the German language

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): NCT04198142


Contacts
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Contact: Birgit Kleim, PhD +41443842351 b.kleim@psychologie.uzh.ch
Contact: Thomas Maeder, M.Sc. +41798489793 thomas.maeder@uzh.ch

Locations
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Switzerland
Psychiatric University Hospital Zurich Recruiting
Zurich, Switzerland, 8032
Contact: Birgit Kleim, PhD    +41443842351    b.kleim@psychologie.uzh.ch   
Contact: Maeder Thomas, M.Sc.    +41443842565    thomas.maeder@uzh.ch   
Sponsors and Collaborators
University of Zurich
Swiss National Science Foundation
Psychiatric University Hospital, Zurich
Publications:
American Psychiatric Association (APA) (2013). Diagnostic and statistical manual of mental disorders (5th ed.). Washington, DC.
Ferini-Strambi, L., Fantini, M. L. (2008). Sleep and quality of life in REM sleep parasomnia. In J. C. Verster, S. R. Pandi-Perumal, & D. L. Streiner (Ed.), Sleep and quality of life in clinical medicine (pp. 119-126). New York City: Humana Press.
Mume, C. O. (2009). Nightmare in schizophrenic and depressed patients, European Journal of Psychiatry, 23(3), 177-183.
Schredl, M. (2003). Continuity between waking and dreaming: A proposal for a mathematical model, Sleep and Hypnosis, 5(1), 26-39.
van Schagen, A., Lancee, J., Spoormaker, V., van den Bout, J. (2016). Long-term treatment effects of Imagery Rehearsal Therapy for nightmares in a population with diverse psychiatric disorders, International Journal of Dream Research, 9, 67-70. doi: 10.11588/ijodr.2016.1.24953.
Cukrowicz, K. C., Otamendi, A., Pinto, J. V., Bernert, R. A., Krakow, B., & Joiner, T. E., Jr. (2006). The impact of insomnia and sleep disturbances on depression and suicidality, Dreaming, 16(1), 1-10. doi: 10.1037/1053-0797.16.1.1
Germain, A., Krakow, B., Faucher, B., Zadra, A., Nielsen, T., Hollifield, M., Warner, T. D.,& Koss, M. P. (2004). Increased mastery elements associated with imagery rehearsal treatment for nightmares in sexual assault survivors with PTSD, Dreaming, 14(4), 195-206. doi: 10.1037/1053-0797.14.4.195
Arntz, A. (2012). Imagery rescripting as a therapeutic technique: Review of clinical trials, basic studies, and research agenda, Journal of Experimental Psychopathology, 3, 189-208. doi: 10.5127/jep.024211
Krakow, B. (2004). Imagery Rehearsal Therapy for chronic posttraumatic nightmares: A mind's eye view. In R. I. Rosner, W. J. Lyddon, & A. Freeman (Ed.), Cognitive therapy and dreams (pp. 89-109). New York: Springer Publishing Co.
Sheaves, B., Onwumere, J., Keen, N., & Kuipers, E. (2015). Treating your worst nightmare: A case-series of Imagery Rehearsal Therapy for nightmares in individuals experiencing psychotic symptoms, The Cognitive Behaviour Therapist, 8(27), 1-17. doi: 10.1017/S1754470X15000665

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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT04198142    
Other Study ID Numbers: 2019-00773
First Posted: December 13, 2019    Key Record Dates
Last Update Posted: December 13, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Zurich:
Psychiatric inpatient care
Additional relevant MeSH terms:
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Mental Disorders
Problem Behavior
Behavioral Symptoms