Menu
Recruiting NCT06441864

Behavioral Treatment for Nightmares in REM Sleep Behavior Disorder

No phase Interventional Nightmare Nightmare Disorder With Associated Other Sleep Disorder REM Sleep Behavior Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cognitive Behavioral Therapy for Nightmares.
Who it may be relevant to
Registry conditions: Nightmare, Nightmare Disorder With Associated Other Sleep Disorder, REM Sleep Behavior Disorder. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Disturbing Dream and Nightmare Severity Index (DDNSI) [Time frame: Baseline and posttreatment]
  • Nightmare frequency (sleep diary) [Time frame: Baseline and posttreatment]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Utah — Salt Lake City

Identifiers

NCT: NCT06441864 · 00187090 · 09-SRG-23

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗