Behavioral Treatment for Nightmares in REM Sleep Behavior Disorder

NCT06441864 | Recruiting

• 2 other identifiers: 0018709009-SRG-23
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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 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.

Conditions

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

Keywords

Imagery Rehearsal Therapy; Cognitive Behavioral Therapy for Nightmares

Outcome Measures

Primary Outcomes (2)

• Disturbing Dream and Nightmare Severity Index (DDNSI)

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

  Baseline and posttreatment

• Nightmare frequency (sleep diary)

  The number of nightmares experienced each day will be collected on daily sleep diaries completed during each assessment period.

  Baseline and posttreatment

Study Arms (2)

2-week baseline

EXPERIMENTAL

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

Behavioral: Cognitive Behavioral Therapy for Nightmares

4-week baseline

EXPERIMENTAL

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

Behavioral: Cognitive Behavioral Therapy for Nightmares

Interventions

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.

Also known as: Imagery Rehearsal Therapy

2-week baseline; 4-week baseline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84108, United States

RECRUITING

MeSH Terms

Conditions

REM Sleep Behavior Disorder

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

REM Sleep Parasomnias; Parasomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Jennifer Mundt, PhD

CONTACT

801-646-8287; RBDstudy@utah.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multiple baseline single case experimental design

Study Record Dates

• First Submitted: May 28, 2024
• First Posted: June 4, 2024
• Study Start: July 15, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)