Nightmare Rescripting and Rehearsal

Sponsor
kathleen mcnamara (U.S. Fed)
Overall Status
Recruiting
CT.gov ID
NCT04529070
Collaborator
(none)
156
1
2
19.3
8.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Nightmare Rescripting and Rehearsal
  • Behavioral: standard of care
N/A

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
156 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Nightmare Rescripting and Rehearsal: Testing a 10-Minute Intervention to Treat Recurring Distressing Dreams in Primary Care.
Actual Study Start Date :
Jan 21, 2021
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention + Standard of care

Nightmare Rescripting and Rehearsal: a 10 minute intervention for Primary Care plus Sleep Hygiene handout.

Behavioral: Nightmare Rescripting and Rehearsal
This study aims to test the efficacy of an abbreviated version of Imagery Rehearsal Therapy ('Nightmare Rescripting and Rehearsal Therapy' (NRRT)) administered by non-mental health professionals in a Primary Care setting.

Behavioral: standard of care
standard of care

Active Comparator: Standard of care

Standard of Care Sleep Hygiene handout alone.

Behavioral: standard of care
standard of care

Outcome Measures

Primary Outcome Measures

  1. Nightmare distress Questionnaire (change from nightmare distress baseline from screening at each 4 visits) [screening, visit 1 (week 0), visit 2 (week 2 +/- 1 week), visit 3 (week 4 +/- 1 week), visit 4 (week 6 +/- 1 week)]

    13 questions, 0-4. 0 indicates lower level of distress and effects as related to nightmares.

  2. Nightmare Frequency in the past week (change from nightmare frequency screening baseline at each 4 visits) [screening, visit 1 (week 0), visit 2 (week 2 +/- 1 week), visit 3 (week 4 +/- 1 week), visit 4 (week 6 +/- 1 week)]

    Boxes numbered one to 31. Pt circles the number corresponding to the number of days they had a nightmare in the past month.

Secondary Outcome Measures

  1. Posttraumatic Stress Disorder Checklist (PTSD) [screening, visit 1 (week 0), visit 2 (week 2 +/- 1 week), visit 3 (week 4 +/- 1 week), visit 4 (week 6 +/- 1 week)]

    The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. The questionnaire is self-report and may be completed in 5-10 minutes. Lower score indicates less severity of PTSD symptoms but is broad enough to pick up a wide base of patients with possible PTSD. Higher scores indicate greater severity and also offeres greater sensitivity.

  2. Beck Depression Inventory II [screening, visit 1 (week 0), visit 2 (week 2 +/- 1 week), visit 3 (week 4 +/- 1 week), visit 4 (week 6 +/- 1 week)]

    BDI-II. This questionnaire self-report and is made up of 21 groups of statements designed to measure attitudes and symptoms of depression severity. Each question has options that are scored on a scale of 0 to 3. Higher scores equals more severity of depression symptoms.

  3. General Anxiety Disorder (anxiety) [screening, visit 1 (week 0), visit 2 (week 2 +/- 1 week), visit 3 (week 4 +/- 1 week), visit 4 (week 6 +/- 1 week)]

    GAD-7. Objective screening tool to use to identify severity of: (Generalized Anxiety Disorder, Panic Disorder, Social Phobia and PostTraumatic Stress Disorder). 7 questions with options 0-3 and with a higher score indicating greater symptom severity.

  4. Insomnia Severity Index (insomnia) [screening, visit 1 (week 0), visit 2 (week 2 +/- 1 week), visit 3 (week 4 +/- 1 week), visit 4 (week 6 +/- 1 week)]

    ISI. Measures insomnia problems occurring in the last 2 weeks. 7 questions with added up scores. Higher score indicates greater symptom severity.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mike O'Callaghan Military Medical Center Nellis Air Force Base Nevada United States 89191

Sponsors and Collaborators

  • kathleen mcnamara

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
kathleen mcnamara, Principal Investigator, Mike O'Callaghan Military Hospital
ClinicalTrials.gov Identifier:
NCT04529070
Other Study ID Numbers:
  • FWH20200116H
First Posted:
Aug 27, 2020
Last Update Posted:
Apr 14, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by kathleen mcnamara, Principal Investigator, Mike O'Callaghan Military Hospital

Study Results

No Results Posted as of Apr 14, 2022