Behavioral Treatment for Nightmares in REM Sleep Behavior Disorder

REM Sleep Behavior Disorder Clinical Trial

Official title:

Behavioral Treatment for Nightmares in REM Sleep Behavior Disorder

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06441864
• Other study ID #: STU00220863
• Secondary ID: 09-SRG-23
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: March 1, 2025

Study information

• Verified date: June 2024
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: March 1, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mental Disorders
• Nightmare
• REM Sleep Behavior Disorder
• Sleep Wake Disorders

Intervention

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. Partners will attend 2 of the 7 treatment sessions. During the sessions, participants will learn techniques for managing and changing nightmares.

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disturbing Dream and Nightmare Severity Index (DDNSI)	The DDNSI is a questionnaire which measures the severity of nightmares.	Through study completion (11-13 weeks)
Primary	Nightmare frequency (sleep diary)	The number of nightmares experienced each day will be collected on daily sleep diaries completed during each assessment period.	Through study completion (11-13 weeks)