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Recruiting

NCT Number: NCT06441864

Behavioral Treatment for Nightmares in REM Sleep Behavior Disorder

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Utah

Salt Lake City, Utah, 84108, United States

Location status: Recruiting

Location contact

Jennifer Mundt, PhD

CONTACT

[email protected]

801-646-8287

Jennifer Mundt, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive Behavioral Therapy for Nightmares

Behavioral

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

Primary outcomes

  1. Disturbing Dream and Nightmare Severity Index (DDNSI)

    Time frame: Baseline and posttreatment

    The DDNSI is a questionnaire which measures the severity of nightmares.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jennifer Mundt, PhD

CONTACT

[email protected]

801-646-8287

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 4, 2024
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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