NightmarePINITNCT04198142
Psychiatric Inpatient Nightmare Treatment
A study testing Imagery Rehearsal Therapy and Treatment as Usual with dream diaries in people with Nightmare and Psychiatric Disorder, run by University of Zurich at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nightmare, Psychiatric Disorder
- What is being tested?
- Imagery Rehearsal Therapy and Treatment as Usual with dream diaries
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- 18 Nov 2019to 31 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Neurological disease
- Shift work
- Trouble speaking and / or understanding the German language
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Psychiatric University Hospital Zurich
Zurich, 8032
Birgit Kleim, PhD, +41443842351, b.kleim@psychologie.uzh.ch
Maeder Thomas, M.Sc., +41443842565, thomas.maeder@uzh.ch
About this study
Official title: Treatment of Nightmares in Psychiatric Inpatients With Imagery Rehearsal Therapy: A Randomized Controlled Trial
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.
Read the detailed description
Nightmares are repeated extremely dysphoric and well-remembered dreams, which typically occur during REM sleep in the second half of sleep (late in the night or during the early morning hours) and upon awakening, individuals quickly become oriented, alert, and conscious of their surroundings. Standard definitions for nightmares often include awakening as an essential criterion, though research suggests that this is not always the case and not all researchers have adopted this waking criterion. Furthermore, although most nightmares occur during REM sleep, they can also occur during non-Rem sleep. Nightmares are very common in psychiatric populations. Studies have found nightmare prevalence rates of 28.4% and 17.5% in depression, 15.6% in anxiety disorders, 24.4% to 25.6% in drug or alcohol abuse, 60% to 90% in Posttraumatic stress disorder (PTSD), and 48% in psychotic disorders. Furthermore, since nightmares often do awaken the individual during the sleep cycle and can make returning to sleep difficult, nightmares can have indirect negative effects through sleep deprivation, which can lead to impaired attention, alertness, reaction time, cognitive processing capacity, memory, mood, ability to stay awake, and heightened pain sensitivity. However, nightmares can also have direct and specific effects. They can affect daily functioning and overall well-being. These implications are even more pronounced in individuals with mental health disorders, where negative outcomes of nightmares were found to often be independent of the co-morbid mental disorders. In psychiatric disorders, nightmares can function as a risk factor, a symptom, and as an exacerbating factor regarding psychiatric symptoms. Nightmares were also found to be significantly associated with higher risk of suicidal ideation, suicide, repeat suicide attempts, and death by suicide, often after controlling for co-morbid mental and other sleep disorders. One cognitive-behavioral-oriented treatment for nightmares is called Imagery Rehearsal Therapy (IRT). IRT asks patients to identify an especially distressing (possibly recurrent) nightmare and 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. In IRT the nightmare can be changed in any way. Some authors argue that imagery rescripting may improve the perceived mastery over nightmares by providing a form of coping by rescripting them. Some authors Arntz speculate that imagery rescripting might modify the fear memory, leading to a reconsolidation with a new meaning that no longer prompts a strong fear response. Imagery rescripting might change the meaning of the original images and the associated automatic emotional processes. Since exposure is not considered to be the most important component of IRT, some authors have pointed out, that the new dream narrative does not have to include material from the original disturbing dream, where solution-oriented thinking may be triggered. IRT is currently among the most studied psychological approaches and is often recommended by guidelines with moderate to large effect sizes. IRT has been shown to be effective for the reduction of nightmare frequency, intensity, and distress. Effects have also been found on depression, anxiety, PTSD symptom severity, sleep quality, insomnia symptoms, and potentially on suicidal ideation. IRT has been used successfully for the treatment of posttraumatic and idiopathic nightmares with sexual assault victims with PTSD, war veterans with PTSD, psychiatric outpatients with various disorders, such as personality disorders, mood disorders, anxiety disorders, and PTSD, and with patients experiencing symptoms of psychosis. Studies have found long-term effects of IRT at follow-ups of 3, 6, 9 and up to 30 months.
To the knowledge of the investigators, there is no randomized controlled trial (RCT), which has investigated the efficacy of IRT in psychiatric inpatients. In order to design the most effective treatment protocol for nightmares, it is necessary to find what works for whom, and how it works. Thus, the proposed project aims to investigate the efficacy of IRT in an RCT with psychiatric inpatients with various disorders. The primary research question is whether IRT has a positive effect on nightmares of psychiatric inpatients in terms of frequency, distress, and intensity, which constitute the outcomes typically used to assess nightmares. A secondary research question is if certain nightmare characteristics and / or treatment characteristics moderate treatment efficacy.
For this study, sixty inpatients with nightmares will be recruited from the inpatient units of the PUK for an RCT. Prior to the first session, patients' electronic files will be screened for inclusion and exclusion criteria and to document medical information, such as current primary diagnoses and current medication. Participants will be randomly assigned to an IRT group or a TAU control group. T0: The first session will consist of informed consent and a first set of self-report questionnaires and interviews, which will assess demographic and personal information, primary psychiatric diagnoses, symptom severity of primary psychiatric diagnoses, psychotherapy motivation and hopefulness, nightmare frequency, nightmare distress, nightmare effects, nightmare content, overall sleep quality, and dream experiences and believes. At the end of the session, both groups will receive a dream diary, which they will fill out for each night for 4 consecutive weeks. The diary will measure nightmare frequency, nightmare distress, nightmare intensity, nightmare content, and if and for how long patients did their imagery exercises.T1: One week later, patients will hand in the completed questionnaires and the IRT group will receive a short IRT intervention. During the IRT session, the therapist will fill out a short questionnaire assessing characteristics of the imagery rescription session. The control 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 for 10 to 15 minutes a day for the rest of the study period.T2: One week after the IRT or control session, patients will receive self-report questionnaires, which will assess symptom severity of primary psychiatric diagnoses, psychotherapy motivation and hopefulness, nightmare frequency, nightmare distress, nightmare effects, nightmare content, overall sleep quality, and dream experiences and believes. Patients of the IRT group will have the opportunity to ask questions about their treatment. T3: One week later, patients will hand in the completed questionnaires and they will receive the same questionnaires to fill out again. Additionally, patients will receive a questionnaire assessing whether and for how long patients did their imagery exercises during the study period. Patients will also hand in their dream diaries. A week later the questionnaires and dream diaries will be collected. Each patient will receive participant reimbursement of 30 Swiss francs (CHF) for their participation in the study. Furthermore, after data is collected, each patients from the control group will be offered an IRT session.
- Conditions
- Nightmare, Psychiatric Disorder
- Being tested
- Imagery Rehearsal Therapy, Treatment as Usual with dream diaries
- Keywords
- Psychiatric inpatient care
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imagery Rehearsal TherapyBehavioural
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.
Treatment as Usual with dream diariesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Imagery Rehearsal Therapy Intervention | Experimental | This group receives one to two sessions of Imagery Rehearsal Therapy. Receives: Behavioral: Imagery Rehearsal Therapy |
| Treatment as Usual with dream diaries | Active comparator | This group receives the usual inpatient care without additional Imagery Rehearsal Therapy sessions, but also keeps dream diaries. Receives: Behavioral: Treatment as Usual with dream diaries |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nightmare frequency (change from baseline to 1 and 2 weeks after intervention)
The Nightmare Frequency Questionnaire and a dream diary will measure the number of nightmares for each night and for each week.
Measured: Baseline, 2 weeks, 3 weeks
Nightmare distress (change from baseline to 1 and 2 weeks after intervention)
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).
Measured: Baseline, 2 weeks, 3 weeks
Nightmare Intensity (change from baseline to 1 and 2 weeks after intervention)
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.
Measured: Baseline, 2 weeks, 3 weeks
Secondary outcomes (11)
Dream experiences and believes (change from baseline to 1 and 2 weeks after intervention)
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.
Measured: Baseline, 2 weeks, 3 weeks, 4 weeks
Overall sleep quality (change from baseline to 1 and 2 weeks after intervention)
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).
Measured: Baseline, 2 weeks, 3 weeks, 4 weeks
Nightmare effects (change from baseline to 1 and 2 weeks after intervention)
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).
Measured: Baseline, 2 weeks, 3 weeks, 4 weeks
Nightmare content (change from baseline to 1 and 2 weeks after intervention)
The Mannheim Dream Questionnaire and a dream diary will measure the qualitative content of each nightmare during a subject's participation period.
Measured: Baseline, 2 weeks, 3 weeks, 4 weeks
Severity of depressive symptoms (change from baseline to 1 and 2 weeks after intervention)
The Beck Depression Inventory will measure current severity of depressive symptoms (minimum value: 0, maximum value: 63). Higher scores indicate a higher severity.
Measured: Baseline, 2 weeks, 3 weeks, 4 weeks
Severity of anxiety symptoms (change from baseline to 1 and 2 weeks after intervention)
The Beck Anxiety Inventory will measure current severity of anxiety symptoms (minimum value: 0, maximum value: 63). Higher scores indicate a higher severity.
Measured: Baseline, 2 weeks, 3 weeks, 4 weeks
Severity of alcohol use (change from baseline to 1 and 2 weeks after intervention)
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.
Measured: Baseline, 2 weeks, 3 weeks, 4 weeks
Severity of drug use (change from baseline to 1 and 2 weeks after intervention)
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.
Measured: Baseline, 2 weeks, 3 weeks, 4 weeks
Severity of PTSD symptoms (change from baseline to 1 and 2 weeks after intervention)
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.
Measured: Baseline, 2 weeks, 3 weeks, 4 weeks
Severity of psychotic symptoms (change from baseline to 1 and 2 weeks after intervention)
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.
Measured: Baseline, 2 weeks, 3 weeks, 4 weeks
Severity of schizophrenia symptoms (change from baseline to 1 and 2 weeks after intervention)
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.
Measured: Baseline, 2 weeks, 3 weeks, 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study start18 Nov 2019
- Primary completion31 May 2020 (estimated)
- Study completion31 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (46)Papers the sponsor has linked to this study.
- Other trials for NightmareStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss National Science Foundation, Psychiatric University Hospital, Zurich
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04198142
- Sponsor's protocol ID
- 2019-00773
- Other IDs
- 2019
- Acronym
- PINIT
- Status last verified
- Dec 2019
- First submitted
- 3 Oct 2019
- Last updated
- 13 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
American Psychiatric Association (APA) (2013). Diagnostic and statistical manual of mental disorders (5th ed.). Washington, DC.
Eiser AS. Dream disorders and treatment. Curr Treat Options Neurol. 2007 Sep;9(5):317-24.
PubMed 17716595Ferini-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.
Zadra A, Pilon M, Donderi DC. Variety and intensity of emotions in nightmares and bad dreams. J Nerv Ment Dis. 2006 Apr;194(4):249-54. doi: 10.1097/01.nmd.0000207359.46223.dc.
PubMed 16614545Levin R, Nielsen TA. Disturbed dreaming, posttraumatic stress disorder, and affect distress: a review and neurocognitive model. Psychol Bull. 2007 May;133(3):482-528. doi: 10.1037/0033-2909.133.3.482.
PubMed 17469988Sandman N, Valli K, Kronholm E, Revonsuo A, Laatikainen T, Paunio T. Nightmares: risk factors among the Finnish general adult population. Sleep. 2015 Apr 1;38(4):507-14. doi: 10.5665/sleep.4560.
PubMed 25325474Mume, C. O. (2009). Nightmare in schizophrenic and depressed patients, European Journal of Psychiatry, 23(3), 177-183.
Swart ML, van Schagen AM, Lancee J, van den Bout J. Prevalence of nightmare disorder in psychiatric outpatients. Psychother Psychosom. 2013;82(4):267-8. doi: 10.1159/000343590. Epub 2013 Jun 1. No abstract available.
PubMed 23735876Cernovsky ZZ. MMPI and nightmares in male alcoholics. Percept Mot Skills. 1985 Dec;61(3 Pt 1):841-2. doi: 10.2466/pms.1985.61.3.841.
PubMed 4088773Cernovsky ZZ. MMPI and nightmare reports in women addicted to alcohol and other drugs. Percept Mot Skills. 1986 Jun;62(3):717-8. doi: 10.2466/pms.1986.62.3.717.
PubMed 3725511Duke LA, Allen DN, Rozee PD, Bommaritto M. The sensitivity and specificity of flashbacks and nightmares to trauma. J Anxiety Disord. 2008;22(2):319-27. doi: 10.1016/j.janxdis.2007.03.002. Epub 2007 Mar 12.
PubMed 17434287Krakow B, Schrader R, Tandberg D, Hollifield M, Koss MP, Yau CL, Cheng DT. Nightmare frequency in sexual assault survivors with PTSD. J Anxiety Disord. 2002;16(2):175-90. doi: 10.1016/s0887-6185(02)00093-2.
PubMed 12194543Reeve S, Sheaves B, Freeman D. Sleep Disorders in Early Psychosis: Incidence, Severity, and Association With Clinical Symptoms. Schizophr Bull. 2019 Mar 7;45(2):287-295. doi: 10.1093/schbul/sby129.
PubMed 30202909Ellis TE, Rufino KA, Nadorff MR. Treatment of Nightmares in Psychiatric Inpatients With Imagery Rehearsal Therapy: An Open Trial and Case Series. Behav Sleep Med. 2019 Mar-Apr;17(2):112-123. doi: 10.1080/15402002.2017.1299738. Epub 2017 Mar 23.
PubMed 28332861Nadorff MR, Lambdin KK, Germain A. Pharmacological and non-pharmacological treatments for nightmare disorder. Int Rev Psychiatry. 2014 Apr;26(2):225-36. doi: 10.3109/09540261.2014.888989.
PubMed 24892897
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Nightmares in Psychiatric Inpatients With Imagery Rehearsal Therapy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04198142
- Acronym / sponsor ID
- PINIT / 2019-00773
- Conditions
- Nightmare, Psychiatric Disorder
- Keywords
- Psychiatric inpatient care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Swiss National Science Foundation, Psychiatric University Hospital, Zurich
- Study start
- 18 Nov 2019 (actual)
- Primary completion
- 31 May 2020 (estimated)
- Study completion
- 31 May 2020 (estimated)
- First posted
- 13 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Nightmares are repeated extremely dysphoric and well-remembered dreams, which typically occur during REM sleep in the second half of sleep (late in the night or during the early morning hours) and upon awakening, individuals quickly become oriented, alert, and conscious of their surroundings. Standard definitions for nightmares often include awakening as an essential criterion, though research suggests that this is not always the case and not all researchers have adopted this waking criterion. Furthermore, although most nightmares occur during REM sleep, they can also occur during non-Rem sleep. Nightmares are very common in psychiatric populations. Studies have found nightmare prevalence rates of 28.4% and 17.5% in depression, 15.6% in anxiety disorders, 24.4% to 25.6% in drug or alcohol abuse, 60% to 90% in Posttraumatic stress disorder (PTSD), and 48% in psychotic disorders. Furthermore, since nightmares often do awaken the individual during the sleep cycle and can make returning to sleep difficult, nightmares can have indirect negative effects through sleep deprivation, which can lead to impaired attention, alertness, reaction time, cognitive processing capacity, memory, mood, ability to stay awake, and heightened pain sensitivity. However, nightmares can also have direct and specific effects. They can affect daily functioning and overall well-being. These implications are even more pronounced in individuals with mental health disorders, where negative outcomes of nightmares were found to often be independent of the co-morbid mental disorders. In psychiatric disorders, nightmares can function as a risk factor, a symptom, and as an exacerbating factor regarding psychiatric symptoms. Nightmares were also found to be significantly associated with higher risk of suicidal ideation, suicide, repeat suicide attempts, and death by suicide, often after controlling for co-morbid mental and other sleep disorders. One cognitive-behavioral-oriented treatment for nightmares is called Imagery Rehearsal Therapy (IRT). IRT asks patients to identify an especially distressing (possibly recurrent) nightmare and 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. In IRT the nightmare can be changed in any way. Some authors argue that imagery rescripting may improve the perceived mastery over nightmares by providing a form of coping by rescripting them. Some authors Arntz speculate that imagery rescripting might modify the fear memory, leading to a reconsolidation with a new meaning that no longer prompts a strong fear response. Imagery rescripting might change the meaning of the original images and the associated automatic emotional processes. Since exposure is not considered to be the most important component of IRT, some authors have pointed out, that the new dream narrative does not have to include material from the original disturbing dream, where solution-oriented thinking may be triggered. IRT is currently among the most studied psychological approaches and is often recommended by guidelines with moderate to large effect sizes. IRT has been shown to be effective for the reduction of nightmare frequency, intensity, and distress. Effects have also been found on depression, anxiety, PTSD symptom severity, sleep quality, insomnia symptoms, and potentially on suicidal ideation. IRT has been used successfully for the treatment of posttraumatic and idiopathic nightmares with sexual assault victims with PTSD, war veterans with PTSD, psychiatric outpatients with various disorders, such as personality disorders, mood disorders, anxiety disorders, and PTSD, and with patients experiencing symptoms of psychosis. Studies have found long-term effects of IRT at follow-ups of 3, 6, 9 and up to 30 months.
To the knowledge of the investigators, there is no randomized controlled trial (RCT), which has investigated the efficacy of IRT in psychiatric inpatients. In order to design the most effective treatment protocol for nightmares, it is necessary to find what works for whom, and how it works. Thus, the proposed project aims to investigate the efficacy of IRT in an RCT with psychiatric inpatients with various disorders. The primary research question is whether IRT has a positive effect on nightmares of psychiatric inpatients in terms of frequency, distress, and intensity, which constitute the outcomes typically used to assess nightmares. A secondary research question is if certain nightmare characteristics and / or treatment characteristics moderate treatment efficacy.
For this study, sixty inpatients with nightmares will be recruited from the inpatient units of the PUK for an RCT. Prior to the first session, patients' electronic files will be screened for inclusion and exclusion criteria and to document medical information, such as current primary diagnoses and current medication. Participants will be randomly assigned to an IRT group or a TAU control group. T0: The first session will consist of informed consent and a first set of self-report questionnaires and interviews, which will assess demographic and personal information, primary psychiatric diagnoses, symptom severity of primary psychiatric diagnoses, psychotherapy motivation and hopefulness, nightmare frequency, nightmare distress, nightmare effects, nightmare content, overall sleep quality, and dream experiences and believes. At the end of the session, both groups will receive a dream diary, which they will fill out for each night for 4 consecutive weeks. The diary will measure nightmare frequency, nightmare distress, nightmare intensity, nightmare content, and if and for how long patients did their imagery exercises.T1: One week later, patients will hand in the completed questionnaires and the IRT group will receive a short IRT intervention. During the IRT session, the therapist will fill out a short questionnaire assessing characteristics of the imagery rescription session. The control 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 for 10 to 15 minutes a day for the rest of the study period.T2: One week after the IRT or control session, patients will receive self-report questionnaires, which will assess symptom severity of primary psychiatric diagnoses, psychotherapy motivation and hopefulness, nightmare frequency, nightmare distress, nightmare effects, nightmare content, overall sleep quality, and dream experiences and believes. Patients of the IRT group will have the opportunity to ask questions about their treatment. T3: One week later, patients will hand in the completed questionnaires and they will receive the same questionnaires to fill out again. Additionally, patients will receive a questionnaire assessing whether and for how long patients did their imagery exercises during the study period. Patients will also hand in their dream diaries. A week later the questionnaires and dream diaries will be collected. Each patient will receive participant reimbursement of 30 Swiss francs (CHF) for their participation in the study. Furthermore, after data is collected, each patients from the control group will be offered an IRT session.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Imagery Rehearsal Therapy Intervention | Experimental | Behavioral: Imagery Rehearsal TherapyThis group receives one to two sessions of Imagery Rehearsal Therapy. |
| Treatment as Usual with dream diaries | Active comparator | Behavioral: Treatment as Usual with dream diariesThis group receives the usual inpatient care without additional Imagery Rehearsal Therapy sessions, but also keeps dream diaries. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Imagery Rehearsal TherapyThe 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. | Behavioural | Imagery Rehearsal Therapy Intervention |
| Treatment as Usual with dream diariesTreatment 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. | Behavioural | Treatment as Usual with dream diaries |
Primary outcome
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.
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).
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.
11 secondary outcomes
Dream experiences and believes (change from baseline to 1 and 2 weeks after intervention)
Time frame: Baseline, 2 weeks, 3 weeks, 4 weeks
Overall sleep quality (change from baseline to 1 and 2 weeks after intervention)
Time frame: Baseline, 2 weeks, 3 weeks, 4 weeks
Nightmare effects (change from baseline to 1 and 2 weeks after intervention)
Time frame: Baseline, 2 weeks, 3 weeks, 4 weeks
Nightmare content (change from baseline to 1 and 2 weeks after intervention)
Time frame: Baseline, 2 weeks, 3 weeks, 4 weeks
Severity of depressive symptoms (change from baseline to 1 and 2 weeks after intervention)
Time frame: Baseline, 2 weeks, 3 weeks, 4 weeks
Severity of anxiety symptoms (change from baseline to 1 and 2 weeks after intervention)
Time frame: Baseline, 2 weeks, 3 weeks, 4 weeks
Severity of alcohol use (change from baseline to 1 and 2 weeks after intervention)
Time frame: Baseline, 2 weeks, 3 weeks, 4 weeks
Severity of drug use (change from baseline to 1 and 2 weeks after intervention)
Time frame: Baseline, 2 weeks, 3 weeks, 4 weeks
Severity of PTSD symptoms (change from baseline to 1 and 2 weeks after intervention)
Time frame: Baseline, 2 weeks, 3 weeks, 4 weeks
Severity of psychotic symptoms (change from baseline to 1 and 2 weeks after intervention)
Time frame: Baseline, 2 weeks, 3 weeks, 4 weeks
Severity of schizophrenia symptoms (change from baseline to 1 and 2 weeks after intervention)
Time frame: Baseline, 2 weeks, 3 weeks, 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2019.
- BackgroundAmerican Psychiatric Association (APA) (2013). Diagnostic and statistical manual of mental disorders (5th ed.). Washington, DC.
- Background: PubMed 17716595Eiser AS. Dream disorders and treatment. Curr Treat Options Neurol. 2007 Sep;9(5):317-24.
- BackgroundFerini-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.
- Background: PubMed 16614545Zadra A, Pilon M, Donderi DC. Variety and intensity of emotions in nightmares and bad dreams. J Nerv Ment Dis. 2006 Apr;194(4):249-54. doi: 10.1097/01.nmd.0000207359.46223.dc.
- Background: PubMed 17469988Levin R, Nielsen TA. Disturbed dreaming, posttraumatic stress disorder, and affect distress: a review and neurocognitive model. Psychol Bull. 2007 May;133(3):482-528. doi: 10.1037/0033-2909.133.3.482.
- Background: PubMed 25325474Sandman N, Valli K, Kronholm E, Revonsuo A, Laatikainen T, Paunio T. Nightmares: risk factors among the Finnish general adult population. Sleep. 2015 Apr 1;38(4):507-14. doi: 10.5665/sleep.4560.
- BackgroundMume, C. O. (2009). Nightmare in schizophrenic and depressed patients, European Journal of Psychiatry, 23(3), 177-183.
- Background: PubMed 23735876Swart ML, van Schagen AM, Lancee J, van den Bout J. Prevalence of nightmare disorder in psychiatric outpatients. Psychother Psychosom. 2013;82(4):267-8. doi: 10.1159/000343590. Epub 2013 Jun 1. No abstract available.
- Background: PubMed 4088773Cernovsky ZZ. MMPI and nightmares in male alcoholics. Percept Mot Skills. 1985 Dec;61(3 Pt 1):841-2. doi: 10.2466/pms.1985.61.3.841.
- Background: PubMed 3725511Cernovsky ZZ. MMPI and nightmare reports in women addicted to alcohol and other drugs. Percept Mot Skills. 1986 Jun;62(3):717-8. doi: 10.2466/pms.1986.62.3.717.
- Background: PubMed 17434287Duke LA, Allen DN, Rozee PD, Bommaritto M. The sensitivity and specificity of flashbacks and nightmares to trauma. J Anxiety Disord. 2008;22(2):319-27. doi: 10.1016/j.janxdis.2007.03.002. Epub 2007 Mar 12.
- Background: PubMed 12194543Krakow B, Schrader R, Tandberg D, Hollifield M, Koss MP, Yau CL, Cheng DT. Nightmare frequency in sexual assault survivors with PTSD. J Anxiety Disord. 2002;16(2):175-90. doi: 10.1016/s0887-6185(02)00093-2.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Imagery Rehearsal Therapy and Treatment as Usual with dream diaries in people with Nightmare and Psychiatric Disorder, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Birgit Kleim, PhD (+41443842351, b.kleim@psychologie.uzh.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nightmare frequency (change from baseline to 1 and 2 weeks after intervention) (time frame: Baseline, 2 weeks, 3 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04198142, which also lists 46 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2019.