Behavioral Treatment for Nightmares in REM Sleep Behavior Disorder

Utah System of Higher Education (USHE)

Status: Enrolling

Conditions: Nightmare Disorder With Associated Other Sleep Disorder; REM Sleep Behavior Disorder; Nightmare

Treatments: Behavioral: Cognitive Behavioral Therapy for Nightmares

Study type: Interventional

Funder types: Other

Identifiers

NCT06441864

09-SRG-23 (Other Grant/Funding Number)

00187090

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

2-week baseline

Experimental group

Description:

Participants will receive treatment after a 2-week baseline assessment period

Treatment:

Behavioral: Cognitive Behavioral Therapy for Nightmares

4-week baseline

Experimental group

Description:

Participants will receive treatment after a 4-week baseline assessment period

Treatment:

Behavioral: Cognitive Behavioral Therapy for Nightmares