Psychiatric Disorder Clinical Trial
— PINITOfficial 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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | May 31, 2020 |
Est. primary completion date | May 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Switzerland | Psychiatric University Hospital Zurich | Zurich |
Lead Sponsor | Collaborator |
---|---|
University of Zurich | Psychiatric University Hospital, Zurich, Swiss National Science Foundation |
Switzerland,
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* Note: There are 46 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Demographic and personal information | 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. | Baseline | |
Other | Primary psychiatric diagnosis | 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). | Baseline | |
Other | Current medication | A medication protocol will document current medication. | Baseline, 2 weeks, 3 weeks, 4 weeks | |
Other | Frequency of imagery exercises during the study participation | 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. | Baseline, 2 weeks, 3 weeks, 4 weeks | |
Other | Duration of imagery exercises during the study participation | 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. | Baseline, 2 weeks, 3 weeks, 4 weeks | |
Other | Characteristics of the imagery rescription session: Trauma relation of the rescripted nightmare | 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. | 1 week after baseline | |
Other | Characteristics of the imagery rescription session: Similarity of the new narrative to the rescripted nightmare | 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. | 1 week after baseline | |
Other | Characteristics of the imagery rescription session: Exposure to rescripted nightmare | 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. | 1 week after baseline | |
Other | Characteristics of the imagery rescription session: Support by the therapist | 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. | 1 week after baseline | |
Other | Characteristics of the imagery rescription session: Emotional intensity of the nightmare | Patients will be asked to rate the emotional intensity of the rescripted nightmare on a scale from 1 to 9. | 1 week after baseline | |
Other | Characteristics of the imagery rescription session: Emotional intensity of the new narrative | Patients will be asked to rate the emotional intensity of the rescripted nightmare on a scale from 1 to 9. | 1 week after baseline | |
Other | Psychotherapy motivation and hopefulness (change from baseline to 1 and 2 weeks after intervention) | 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). | Baseline, 2 weeks, 3 weeks, 4 weeks | |
Primary | 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. | Baseline, 2 weeks, 3 weeks | |
Primary | 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). | Baseline, 2 weeks, 3 weeks | |
Primary | 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. | Baseline, 2 weeks, 3 weeks | |
Secondary | 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, deĀ“ja` vu experiences based on dreams) for each week. | Baseline, 2 weeks, 3 weeks, 4 weeks | |
Secondary | 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). | Baseline, 2 weeks, 3 weeks, 4 weeks | |
Secondary | 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). | Baseline, 2 weeks, 3 weeks, 4 weeks | |
Secondary | 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. | Baseline, 2 weeks, 3 weeks, 4 weeks | |
Secondary | 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. | Baseline, 2 weeks, 3 weeks, 4 weeks | |
Secondary | 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. | Baseline, 2 weeks, 3 weeks, 4 weeks | |
Secondary | 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. | Baseline, 2 weeks, 3 weeks, 4 weeks | |
Secondary | 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. | Baseline, 2 weeks, 3 weeks, 4 weeks | |
Secondary | 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. | Baseline, 2 weeks, 3 weeks, 4 weeks | |
Secondary | 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. | Baseline, 2 weeks, 3 weeks, 4 weeks | |
Secondary | 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. | Baseline, 2 weeks, 3 weeks, 4 weeks |
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