Behavioral Treatment for Nightmares in 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 →
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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