PINIT: Psychiatric Inpatient Nightmare Treatment

• Sponsor: University of Zurich (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04198142
• Collaborator: Swiss National Science Foundation (Other), Psychiatric University Hospital, Zurich (Other)
• Enrollment: 60
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 6.4
• Patients Per Site Per Month: 9.4

Study Details

Study Description

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	N/A

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

• Study Type: Interventional
• Anticipated 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: Nov 18, 2019
• Anticipated Primary Completion Date: May 31, 2020
• Anticipated Study Completion Date: May 31, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Nightmare frequency (change from baseline to 1 and 2 weeks after intervention) [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) [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) [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) [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) [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) [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) [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) [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) [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) [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) [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) [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) [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) [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 [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 [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 [Baseline, 2 weeks, 3 weeks, 4 weeks]

   A medication protocol will document current medication.

4. Frequency of imagery exercises during the study participation [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 [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 [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 [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 [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 [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 [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 [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) [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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Psychiatric University Hospital Zurich	Zurich		Switzerland	8032

Sponsors and Collaborators

• University of Zurich
• Swiss National Science Foundation
• Psychiatric University Hospital, Zurich

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

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• Responsible Party: University of Zurich
• ClinicalTrials.gov Identifier: NCT04198142
• Other Study ID Numbers: 2019-00773
• First Posted: Dec 13, 2019
• Last Update Posted: Dec 13, 2019
• Last Verified: Dec 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• 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: Mental Disorders; Problem Behavior

Study Results

No Results Posted as of Dec 13, 2019