Clinical trial NCT04198142: Psychiatric Inpatient Nightmare Treatment
Official title: Treatment of Nightmares in Psychiatric Inpatients With Imagery Rehearsal Therapy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nightmare
Psychiatric Disorder
Keywords: Psychiatric inpatient care
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Swiss National Science Foundation
name: Psychiatric University Hospital, Zurich
First posted: 2019-12-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Nightmare frequency (change from baseline to 1 and 2 weeks after intervention)
timeFrame: Baseline, 2 weeks, 3 weeks
measure: Nightmare distress (change from baseline to 1 and 2 weeks after intervention)
timeFrame: Baseline, 2 weeks, 3 weeks
measure: Nightmare Intensity (change from baseline to 1 and 2 weeks after intervention)
timeFrame: Baseline, 2 weeks, 3 weeks
Secondary outcomes:
measure: Dream experiences and believes (change from baseline to 1 and 2 weeks after intervention)
timeFrame: Baseline, 2 weeks, 3 weeks, 4 weeks
measure: Overall sleep quality (change from baseline to 1 and 2 weeks after intervention)
timeFrame: Baseline, 2 weeks, 3 weeks, 4 weeks
measure: Nightmare effects (change from baseline to 1 and 2 weeks after intervention)
timeFrame: Baseline, 2 weeks, 3 weeks, 4 weeks
measure: Nightmare content (change from baseline to 1 and 2 weeks after intervention)
timeFrame: Baseline, 2 weeks, 3 weeks, 4 weeks
measure: Severity of depressive symptoms (change from baseline to 1 and 2 weeks after intervention)
timeFrame: Baseline, 2 weeks, 3 weeks, 4 weeks
measure: Severity of anxiety symptoms (change from baseline to 1 and 2 weeks after intervention)
timeFrame: Baseline, 2 weeks, 3 weeks, 4 weeks
measure: Severity of alcohol use (change from baseline to 1 and 2 weeks after intervention)
timeFrame: Baseline, 2 weeks, 3 weeks, 4 weeks
measure: Severity of drug use (change from baseline to 1 and 2 weeks after intervention)
timeFrame: Baseline, 2 weeks, 3 weeks, 4 weeks
measure: Severity of PTSD symptoms (change from baseline to 1 and 2 weeks after intervention)
timeFrame: Baseline, 2 weeks, 3 weeks, 4 weeks
measure: Severity of psychotic symptoms (change from baseline to 1 and 2 weeks after intervention)
timeFrame: Baseline, 2 weeks, 3 weeks, 4 weeks
measure: Severity of schizophrenia symptoms (change from baseline to 1 and 2 weeks after intervention)
timeFrame: Baseline, 2 weeks, 3 weeks, 4 weeks
Other outcomes:
measure: Demographic and personal information
timeFrame: Baseline
measure: Primary psychiatric diagnosis
timeFrame: Baseline
measure: Current medication
timeFrame: Baseline, 2 weeks, 3 weeks, 4 weeks
measure: Frequency of imagery exercises during the study participation
timeFrame: Baseline, 2 weeks, 3 weeks, 4 weeks
measure: Duration of imagery exercises during the study participation
timeFrame: Baseline, 2 weeks, 3 weeks, 4 weeks
measure: Characteristics of the imagery rescription session: Trauma relation of the rescripted nightmare
timeFrame: 1 week after baseline
measure: Characteristics of the imagery rescription session: Similarity of the new narrative to the rescripted nightmare
timeFrame: 1 week after baseline
measure: Characteristics of the imagery rescription session: Exposure to rescripted nightmare
timeFrame: 1 week after baseline
measure: Characteristics of the imagery rescription session: Support by the therapist
timeFrame: 1 week after baseline
measure: Characteristics of the imagery rescription session: Emotional intensity of the nightmare
timeFrame: 1 week after baseline
measure: Characteristics of the imagery rescription session: Emotional intensity of the new narrative
timeFrame: 1 week after baseline
measure: Psychotherapy motivation and hopefulness (change from baseline to 1 and 2 weeks after intervention)
timeFrame: Baseline, 2 weeks, 3 weeks, 4 weeks
Locations:
city: Zurich
country: Switzerland
facility: Psychiatric University Hospital Zurich
Study officials:
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