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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Aged 18 years or older
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up screening, visit 1 (week 0), visit 2 (week 2 +/- 1 week), visit 3 (week 4 +/- 1 week), visit 4 (week 6 +/- 1 week)
Awards & highlights
No Placebo-Only Group
Summary
This trialwill test a quick therapy to help people with recurring nightmares in a primary care setting.
Who is the study for?
This trial is for adults aged 18+ who have recurring nightmares at least three times a month and are receiving care at Nellis Air Force Base. Participants must also score at least 15 on specific nightmare distress and frequency tools to qualify.
What is being tested?
The study tests 'Nightmare Rescripting and Rehearsal Therapy' (NRRT), a brief intervention by non-mental health professionals in primary care, against standard sleep hygiene education. The impact on nightmare distress and frequency will be measured over six weeks.
What are the potential side effects?
Since NRRT is a psychological therapy involving no medication, side effects may include temporary increases in distress due to discussing or engaging with nightmare content but typically do not involve physical side effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ screening, visit 1 (week 0), visit 2 (week 2 +/- 1 week), visit 3 (week 4 +/- 1 week), visit 4 (week 6 +/- 1 week)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~screening, visit 1 (week 0), visit 2 (week 2 +/- 1 week), visit 3 (week 4 +/- 1 week), visit 4 (week 6 +/- 1 week)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Nightmare Frequency in the past week (change from nightmare frequency screening baseline at each 4 visits)
Nightmare distress Questionnaire (change from nightmare distress baseline from screening at each 4 visits)
Secondary study objectives
Beck Depression Inventory II
General Anxiety Disorder (anxiety)
Insomnia Severity Index (insomnia)
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention + Standard of careExperimental Treatment2 Interventions
Nightmare Rescripting and Rehearsal: a 10 minute intervention for Primary Care plus Sleep Hygiene handout.
Group II: Standard of careActive Control1 Intervention
Standard of Care Sleep Hygiene handout alone.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
standard of care
2008
Completed Phase 4
~3640
Find a Location
Who is running the clinical trial?
kathleen mcnamaraLead Sponsor
David MossLead Sponsor
4 Previous Clinical Trials
626 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had disturbing dreams at least three times a month for the last month.You must have nightmares, but they can't be too severe. You need to score at least 15 out of 52 on a questionnaire about your nightmares.You must be able to receive medical care at a military base called Nellis Air Force Base to participate in this study.I am 18 years old or older.Only civilians are eligible to participate, not active military personnel or their dependents.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention + Standard of care
- Group 2: Standard of care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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