Behavioral Treatment for Nightmares in REM Sleep Behavior Disorder

March 9, 2026 updated by: University of Utah
The purpose of this clinical trial is learn whether a behavioral (non-medication) treatment can reduce nightmares in adults with Rapid Eye Movement (REM) Sleep Behavior Disorder (RBD). People with RBD will be enrolled in the study along with their family members (a partner or other family member residing in the same home). All participants will receive the treatment via videoconference and will complete 2 assessments. Participants with RBD will attend 7 sessions, and their family members will attend 2 of those sessions with them.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84108
        • Recruiting
        • University of Utah
        • Principal Investigator:
          • Jennifer Mundt, PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis of isolated RBD or RBD secondary to neurodegenerative disease
  • Age 18 or older
  • Speak, read, and write English
  • Live in the United States
  • Nightmare frequency ≥3 times per week
  • Disturbing Dream and Nightmare Severity Index score indicative of nightmare disorder
  • Sleep, neurological, and psychiatric medications stable for at least 1 month and willing to keep medications stable through the course of the study
  • Live with a family member who is willing to participate in the study

Exclusion Criteria:

  • Possible dementia
  • Narcolepsy
  • Posttraumatic stress disorder
  • Previous behavioral treatment for nightmares
  • Currently engaged in sleep- or trauma-focused psychotherapy
  • Taking a medication that could cause RBD, if the medication was started prior to onset of RBD symptoms

Inclusion Criteria (Family Members):

  • Live with a family member who meets all of the above criteria
  • Age 18 or older
  • Speak, read, and write English
  • Live in the United States

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 2-week baseline
Participants will receive treatment after a 2-week baseline assessment period
Behavioral: Cognitive Behavioral Therapy for Nightmares
The intervention will consist of 7 therapy sessions (once per week for 7 weeks) which will be delivered via videoconference. Family members will attend 2 of the 7 treatment sessions. During the sessions, participants will learn techniques for managing and changing nightmares.
Other Names:
  • Imagery Rehearsal Therapy
Experimental: 4-week baseline
Participants will receive treatment after a 4-week baseline assessment period
Behavioral: Cognitive Behavioral Therapy for Nightmares
The intervention will consist of 7 therapy sessions (once per week for 7 weeks) which will be delivered via videoconference. Family members will attend 2 of the 7 treatment sessions. During the sessions, participants will learn techniques for managing and changing nightmares.
Other Names:
  • Imagery Rehearsal Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disturbing Dream and Nightmare Severity Index (DDNSI)
Time Frame: Baseline and posttreatment
The DDNSI is a questionnaire which measures the severity of nightmares.
Baseline and posttreatment
Nightmare frequency (sleep diary)
Time Frame: Baseline and posttreatment
The number of nightmares experienced each day will be collected on daily sleep diaries completed during each assessment period.
Baseline and posttreatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Utah

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

May 28, 2024

First Submitted That Met QC Criteria

June 3, 2024

First Posted (Actual)

June 4, 2024

Study Record Updates

Last Update Posted (Actual)

March 12, 2026

Last Update Submitted That Met QC Criteria

March 9, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00187090
  • 09-SRG-23 (Other Grant/Funding Number: Sleep Research Society Foundation)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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