Narcolepsy Nightmare Study

• Imagery rehearsal therapy (Behavioral), also known as IRT: Therapy to reduce nightmares, delivered via videoconference sessions
• Targeted dream control (Behavioral), also known as TDC: Therapy to reduce nightmares, delivered in videoconference sessions and lab session. Lab session will involve a sleep study during a daytime nap.

Primary outcomes

• Nightmare Frequency [Baseline (assessed daily for 2 or 4 weeks) and posttreatment (assessed daily for 2 weeks beginning in week 9 or 11)]: Frequency of nightmares as measured by daily diary
• Disturbing Dream and Nightmare Severity Scale [Baseline and posttreatment (up to 13 weeks)]: Measures nightmare severity. Minimum = 0, maximum = 37. Higher scores represent a worse severity of nightmares.

Secondary outcomes

• Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety Scale [Baseline and posttreatment (up to 13 weeks)]: Measures symptoms using Computer Adaptive Testing (CAT) with higher scores reflecting more anxiety symptoms (worse outcome). Population mean (T-score) of 50 with a standard deviation of 10.
• Patient Reported Outcomes Measurement Information System (PROMIS) Depression Scale [Baseline and posttreatment (up to 13 weeks)]: Measures symptoms using Computer Adaptive Testing (CAT) with higher scores reflecting more depressive symptoms (worse outcome). Population mean (T-score) of 50 with a standard deviation of 10.

Other outcomes

• Dream Enactment Frequency [Baseline (assessed daily for 2 or 4 weeks) and posttreatment (assessed daily for 2 weeks beginning in week 9 or 11)]: Frequency of dream enactment as measured by daily diary
• Sleep Talking Frequency [Baseline (assessed daily for 2 or 4 weeks) and posttreatment (assessed daily for 2 weeks beginning in week 9 or 11)]: Frequency of sleep talking as measured by daily diary
• Lucid Dreams Without Control Frequency [Baseline (assessed daily for 2 or 4 weeks) and posttreatment (assessed daily for 2 weeks beginning in week 9 or 11)]: Frequency of lucid dreams without control as measured by daily diary
• Lucid Dreams With Control Frequency [Baseline (assessed daily for 2 or 4 weeks) and posttreatment (assessed daily for 2 weeks beginning in week 9 or 11)]: Frequency of lucid dreams with control as measured by daily diary
• Sleep-related Hallucinations Frequency [Baseline (assessed daily for 2 or 4 weeks) and posttreatment (assessed daily for 2 weeks beginning in week 9 or 11)]: Frequency of sleep-related hallucinations as measured by daily diary
• Sleep Paralysis Frequency [Baseline (assessed daily for 2 or 4 weeks) and posttreatment (assessed daily for 2 weeks beginning in week 9 or 11)]: Frequency of sleep paralysis as measured by daily diary
• Patient Reported Outcomes Measurement Information System (PROMIS) General Self-Efficacy [Baseline and posttreatment (up to 13 weeks)]: Measures symptoms using Computer Adaptive Testing (CAT) with higher scores reflecting more self-efficacy (better outcome). Population mean (T-score) of 50 with a standard deviation of 10.
• Patient Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy for Managing Symptoms [Baseline and posttreatment (up to 13 weeks)]: Measures symptoms using Computer Adaptive Testing (CAT) with higher scores reflecting more self-efficacy (better outcome). Population mean (T-score) of 50 with a standard deviation of 10.
• Nightmare Disorder Index [Baseline and posttreatment (up to 13 weeks)]: Measures nightmare severity. Minimum = 0, maximum = 20. Higher scores represent a worse severity of nightmares.
• Epworth Sleepiness Scale [Baseline and posttreatment (up to 13 weeks)]: Measures daytime sleepiness. Minimum = 0, maximum = 24. Higher scores represent worse daytime sleepiness.
• Hypersomnia Severity Index [Baseline and posttreatment (up to 13 weeks)]: Measures the severity of hypersomnia symptoms. Minimum = 0, maximum = 36. Higher scores represent worse symptoms.
• Functional Outcomes of Sleep Questionnaire-10 [Baseline and posttreatment (up to 13 weeks)]: Measures daytime functioning related to hypersomnia. Minimum = 5, maximum = 20. Higher scores represent better functioning.
• Paris Arousal Disorders Severity Scale [Baseline and posttreatment (up to 13 weeks)]: Measures the severity of non-REM parasomnia symptoms. Minimum = 0, maximum = 50. Higher scores represent worse symptoms.
• Lucid Dream Skills Questionnaire (LUSK) [Baseline and posttreatment (up to 13 weeks)]: The Lucid Dream Skills Questionnaire (LUSK) measures the frequency of lucid dreaming. The LUSK total score ranges from 0-4 (the mean of the item scores), with higher scores representing a higher frequency of lucid dreaming. In general, a higher frequency of lucid dreaming is not inherently "better" or "worse." For the purpose of this trial, one of the intervention components (Targeted Dream Control) attempted to increase lucid dreaming, so a higher score for this trial would indicate an improvement.
• Dream Delusions Scale [Baseline and posttreatment (up to 13 weeks)]: Measures the severity of dream delusions. Minimum = 0, maximum = 12. Higher scores represent worse dream delusions.

Sex: All, ages: 18 Years to any

Inclusion Criteria (all participants):

* Diagnosis of narcolepsy
* Age 18 or older
* Speak English
* Live in the United States
* Receiving standard medical care for narcolepsy
* Sleep and psychiatric medications stable for at least 3 months
* Nightmare frequency of ≥3 times per week
* Nightmare Disorder Index score indicates probable nightmare disorder

Inclusion Criteria (Chicago area participants):

* Able to attend a study appointment in Evanston, IL
* Able and willing to not take wake-promoting medications on day of lab visit

Exclusion Criteria:

* History of a neurological disorder that might alter EEG
* Currently engaged in sleep- or trauma-focused psychotherapy
* Previous behavioral treatment for nightmares
* Medical, psychiatric, or cognitive condition which would interfere with ability to engage in the treatment
* Untreated sleep apnea (AHI ≥ 5)

Participant flow

Outcome results

• Nightmare Frequency (Primary), Mean, nightmares per week: Imagery Rehearsal Therapy (IRT) 12.75 +/- 8.13; Imagery Rehearsal Therapy and Targeted Dream Control (IRT+TDC) 4.00 +/- 1.39
• Disturbing Dream and Nightmare Severity Scale (Primary), Mean, score on a scale: Imagery Rehearsal Therapy (IRT) 23.67 +/- 8.02; Imagery Rehearsal Therapy and Targeted Dream Control (IRT+TDC) 18.33 +/- 2.89
• Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety Scale (Secondary), Mean, score on a scale: Imagery Rehearsal Therapy (IRT) 58.80 +/- 10.91; Imagery Rehearsal Therapy and Targeted Dream Control (IRT+TDC) 50.33 +/- 8.03
• Patient Reported Outcomes Measurement Information System (PROMIS) Depression Scale (Secondary), Mean, score on a scale: Imagery Rehearsal Therapy (IRT) 56.33 +/- 3.69; Imagery Rehearsal Therapy and Targeted Dream Control (IRT+TDC) 50.27 +/- 5.28
• Dream Enactment Frequency (Other pre specified), Mean, dream enactment episodes per week: Imagery Rehearsal Therapy (IRT) 2.17 +/- 2.57; Imagery Rehearsal Therapy and Targeted Dream Control (IRT+TDC) 1.42 +/- 1.28
• Sleep Talking Frequency (Other pre specified), Mean, sleep talking episodes per week: Imagery Rehearsal Therapy (IRT) 12.92 +/- 9.64; Imagery Rehearsal Therapy and Targeted Dream Control (IRT+TDC) 1.08 +/- 1.66
• Lucid Dreams Without Control Frequency (Other pre specified), Mean, episodes per week: Imagery Rehearsal Therapy (IRT) 3.83 +/- 3.51; Imagery Rehearsal Therapy and Targeted Dream Control (IRT+TDC) 3.08 +/- 3.84
• Lucid Dreams With Control Frequency (Other pre specified), Mean, episodes per week: Imagery Rehearsal Therapy (IRT) 2.42 +/- 3.97; Imagery Rehearsal Therapy and Targeted Dream Control (IRT+TDC) 2.83 +/- 4.91
• Sleep-related Hallucinations Frequency (Other pre specified), Mean, sleep-related hallucinations per week: Imagery Rehearsal Therapy (IRT) 7.58 +/- 8.32; Imagery Rehearsal Therapy and Targeted Dream Control (IRT+TDC) 1.50 +/- 2.60
• Sleep Paralysis Frequency (Other pre specified), Mean, sleep paralysis episodes per week: Imagery Rehearsal Therapy (IRT) 2.00 +/- 1.80; Imagery Rehearsal Therapy and Targeted Dream Control (IRT+TDC) 1.00 +/- 1.32
• Patient Reported Outcomes Measurement Information System (PROMIS) General Self-Efficacy (Other pre specified), Mean, score on a scale: Imagery Rehearsal Therapy (IRT) 51.57 +/- 7.87; Imagery Rehearsal Therapy and Targeted Dream Control (IRT+TDC) 49.83 +/- 4.74
• Patient Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy for Managing Symptoms (Other pre specified), Mean, score on a scale: Imagery Rehearsal Therapy (IRT) 35.77 +/- 3.72; Imagery Rehearsal Therapy and Targeted Dream Control (IRT+TDC) 40.53 +/- 1.44
• Nightmare Disorder Index (Other pre specified), Mean, score on a scale: Imagery Rehearsal Therapy (IRT) 13.33 +/- 1.53; Imagery Rehearsal Therapy and Targeted Dream Control (IRT+TDC) 11.00 +/- 1.73
• Epworth Sleepiness Scale (Other pre specified), Mean, score on a scale: Imagery Rehearsal Therapy (IRT) 14.33 +/- 4.04; Imagery Rehearsal Therapy and Targeted Dream Control (IRT+TDC) 19.00 +/- 5.00
• Hypersomnia Severity Index (Other pre specified), Mean, score on a scale: Imagery Rehearsal Therapy (IRT) 28.67 +/- 5.13; Imagery Rehearsal Therapy and Targeted Dream Control (IRT+TDC) 23.00 +/- 4.00
• Functional Outcomes of Sleep Questionnaire-10 (Other pre specified), Mean, score on a scale: Imagery Rehearsal Therapy (IRT) 10.78 +/- 3.91; Imagery Rehearsal Therapy and Targeted Dream Control (IRT+TDC) 10.44 +/- 1.59
• Paris Arousal Disorders Severity Scale (Other pre specified), Mean, score on a scale: Imagery Rehearsal Therapy (IRT) 19.33 +/- 2.31; Imagery Rehearsal Therapy and Targeted Dream Control (IRT+TDC) 9.67 +/- 4.04
• Lucid Dream Skills Questionnaire (LUSK) (Other pre specified), Mean, score on a scale: Imagery Rehearsal Therapy (IRT) 1.30 +/- 1.30; Imagery Rehearsal Therapy and Targeted Dream Control (IRT+TDC) 1.37 +/- 0.74
• Dream Delusions Scale (Other pre specified), Mean, score on a scale: Imagery Rehearsal Therapy (IRT) 5.00 +/- 1.00; Imagery Rehearsal Therapy and Targeted Dream Control (IRT+TDC) 1.67 +/- 2.89

Adverse events

Time frame: 11-13 weeks

Other adverse events by term

• Study Protocol and Statistical Analysis Plan (PDF, 2024-10-29)

• Jennifer Mundt, PhD, Principal investigator, Northwestern University