Behavioral Treatment for Nightmares in REM Sleep Behavior Disorder

Not Applicable

Suspended

• Conditions: Nightmare; Nightmare Disorder with Associated Other Sleep Disorder; REM Sleep Behavior Disorder
• Interventions: Behavioral: Cognitive Behavioral Therapy for Nightmares

• Registration Number: NCT06441864
• Lead Sponsor: University of Utah

Brief Summary

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 romantic partners. All participants will receive the treatment via videoconference and will complete 2 assessments. Participants with RBD will attend 7 sessions, and their partners will attend 2 of those sessions with them.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-05-28
• Study First Submitted QC: 2024-06-03
• Study First Posted: 2024-06-04
• Study Start: 2024-07-15
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-13
• Primary Completion: 2025-09-01
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 20

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 romantic partner 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 (Partners):

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
4-week baseline	Cognitive Behavioral Therapy for Nightmares	Participants will receive treatment after a 4-week baseline assessment period
2-week baseline	Cognitive Behavioral Therapy for Nightmares	Participants will receive treatment after a 2-week baseline assessment period

Primary Outcome Measures

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

Trial Locations

Locations (1)

University of Utah; 🇺🇸 Salt Lake City, Utah, United States