Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Nightmare Rescripting and Rehearsal

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04529070
Recruitment Status : Recruiting
First Posted : August 27, 2020
Last Update Posted : February 23, 2021
Sponsor:
Information provided by (Responsible Party):
kathleen mcnamara, Mike O'Callaghan Military Hospital

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
Nightmare Sleep Behavioral: Nightmare Rescripting and Rehearsal Behavioral: standard of care Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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 : January 21, 2021
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2022

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




Primary Outcome Measures :
  1. Nightmare distress Questionnaire (change from nightmare distress baseline from screening at each 4 visits) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04529070


Contacts
Layout table for location contacts
Contact: Jill M Clark, MBA 7026533298 jill.m.clark15.ctr@mail.mil

Locations
Layout table for location information
United States, Nevada
Mike O'Callaghan Military Medical Center Recruiting
Nellis Air Force Base, Nevada, United States, 89191
Contact: Amanda J Crawford, MSHS    702-653-3298    amanda.j.crawford.ctr@mail.mil   
Contact: Jill M Clark, MBA/HCM    702-653-3298    jill.m.clark15.ctr@mail.mil   
Sponsors and Collaborators
kathleen mcnamara
Publications:
American Psychiatric Association. (2013). Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition. Arlington, VA: American Psychiatric Association.
Belicki K. (1992). The relationship of nightmare frequency to nightmare suffering with implications for treatment and research. Dreaming 2 143-148. 10.1037/h0094355
Böckermann, M., Gieselmann, A., & Pietrowsky, R. (2014). What does nightmare distress mean? Factorial structure and psychometric properties of the Nightmare Distress Questionnaire (NDQ). Dreaming, 24(4), 279-289. https://doi.org/10.1037/a0037749
Harb, G. C., Forbes, D., Phelps, A., Gehrman, P. R., Cook, J. M., Gamble, G. & Ross, R. J. (2010). Treatment Manual for Imagery Rehearsal + cCBT for Insomnia.
Köthe, M. & Pietrowsky, R. (2001). Behavioral effects of nightmares and their correlations to personality patterns. Dreaming, 11, 43-52.
Pruiksma, K. E., Slavish, D., Wardle, S. Ojeda, A., Taylor, D., Peterson, A., Kelly, K., Maur, D., Mintz, J., Litz, B., Borah, E., Brundige, A., Young-McCaughan, S., Williamson, D. (2019). Prevalence and correlates of nightmares in Active Duty Service Members. Sleep, (42)1, A267. https://doi.org/10.1093/sleep/zsz067.667

Layout table for additonal information
Responsible Party: kathleen mcnamara, Principal Investigator, Mike O'Callaghan Military Hospital
ClinicalTrials.gov Identifier: NCT04529070    
Other Study ID Numbers: FWH20200116H
First Posted: August 27, 2020    Key Record Dates
Last Update Posted: February 23, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We do not plan on sharing data.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by kathleen mcnamara, Mike O'Callaghan Military Hospital:
nightmare rescripting
dreams
behavioral health
sleep