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Nightmare Rescripting and Rehearsal

D

David Moss

Status

Terminated

Conditions

Nightmare
Sleep

Treatments

Behavioral: standard of care
Behavioral: Nightmare Rescripting and Rehearsal

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT04529070
FWH20200116H

Details and patient eligibility

About

This study aims to test the efficacy of an abbreviated version of Imagery Rehearsal Therapy administered by non-mental health professionals in a Primary Care setting. This treatment, to be called 'Nightmare Rescripting and Rehearsal Therapy' (NRRT) would arm Primary Care medical personnel with a nonpharmacologic, ten minute intervention for treating recurring nightmares.

The study will provide sleep hygiene education to both the control and experiment groups, NRRT to the experiment group only, and compare their Nightmare Distress Questionnaire and Nightmare Frequency Tool at two (2), four (4), and six (6) week intervals.

Full description

This is a prospective Randomized Controlled Trial to determine if a standard of care sleep hygiene handout plus a brief 10 minute intervention for recurring nightmares (Nightmare Rescripting and Rehearsal Therapy) reduces scores on the Nightmare Distress Questionnaire and Nightmare Frequency Tool, when compared to patients solely receiving a handout outlining sleep hygiene techniques. Individuals with a minimum score on the Nightmare Distress Questionnaire and Nightmare Frequency Tool of 15 out of a possible 52 who meet all other inclusion criteria will be invited to participate.

A clinically significant reduction will be considered if a decrease in Nightmare Distress and Frequency measures is greater than or equal to 25% from baseline. Secondary outcomes will include PCL-5 (PTSD), PHQ9 (Depression), GAD7 (Anxiety), ISI (Insomnia Severity Index) scores.

Enrollment

68 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

**Patients must be able to get care at Nellis Air Force Base (a military installation) in order to participate in this study**

Inclusion Criteria:

  • Active Duty members and DoD beneficiaries.
  • Aged 18 years or older
  • Recurring disturbing dreams (at least three times per month for the past one month)
  • Participants must score a 15 out of a possible 52 on the Nightmare Distress Questionnaire and Nightmare Frequency Tool in order to qualify.

Exclusion Criteria:

  • Aged less than 18 years old
  • Unwilling to refrain from taking an over the counter or prescription medication for the purpose of improving sleep during the course of the study.
  • Participants that score less than a 15 out of a possible 52 on the Nightmare Distress Questionnaire and Nightmare Frequency will be excluded

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

68 participants in 2 patient groups

Intervention + Standard of care
Experimental group
Description:
Nightmare Rescripting and Rehearsal: a 10 minute intervention for Primary Care plus Sleep Hygiene handout.
Treatment:
Behavioral: Nightmare Rescripting and Rehearsal
Behavioral: standard of care
Standard of care
Active Comparator group
Description:
Standard of Care Sleep Hygiene handout alone.
Treatment:
Behavioral: standard of care

Trial contacts and locations

1

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Central trial contact

Jill M Clark, MBA

Data sourced from clinicaltrials.gov

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