NightmareNCT06441864
Behavioral Treatment for Nightmares in REM Sleep Behavior Disorder
A study testing Cognitive Behavioral Therapy for Nightmares in people with Nightmare and Nightmare Disorder With Associated Other Sleep Disorder, run by University of Utah at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nightmare, Nightmare Disorder With Associated Other Sleep Disorder, REM Sleep Behavior Disorder
- What is being tested?
- Cognitive Behavioral Therapy for Nightmares
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2024to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Utah
Salt Lake City, Utah, 84108
Jennifer Mundt, PhD, 801-646-8287, RBDstudy@utah.edu
Jennifer Mundt, PhD
About this study
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
- Nightmare, Nightmare Disorder With Associated Other Sleep Disorder, REM Sleep Behavior Disorder
- Being tested
- Cognitive Behavioral Therapy for Nightmares
- Keywords
- Imagery Rehearsal Therapy, Cognitive Behavioral Therapy for Nightmares
- Medical subject headings
- REM Sleep Behavior Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy for NightmaresBehavioural
Also called Imagery Rehearsal Therapy
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.
| Study group | Role | What they receive |
|---|---|---|
| 2-week baseline | Experimental | Participants will receive treatment after a 2-week baseline assessment period Receives: Behavioral: Cognitive Behavioral Therapy for Nightmares |
| 4-week baseline | Experimental | Participants will receive treatment after a 4-week baseline assessment period Receives: Behavioral: Cognitive Behavioral Therapy for Nightmares |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disturbing Dream and Nightmare Severity Index (DDNSI)
The DDNSI is a questionnaire which measures the severity of nightmares.
Measured: 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.
Measured: Baseline and posttreatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start15 Jul 2024
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NightmareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multiple baseline single case experimental design
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06441864
- Sponsor's protocol ID
- 00187090
- Other IDs
- 09-SRG-23
- Status last verified
- Mar 2026
- First submitted
- 28 May 2024
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Treatment for Nightmares in REM Sleep Behavior Disorder
- ClinicalTrials.gov ID
- NCT06441864
- Acronym / sponsor ID
- 00187090
- Conditions
- Nightmare, Nightmare Disorder With Associated Other Sleep Disorder, REM Sleep Behavior Disorder
- Keywords
- Imagery Rehearsal Therapy, Cognitive Behavioral Therapy for Nightmares
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 15 Jul 2024 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 4 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multiple baseline single case experimental design
| Arm | Type | Receives |
|---|---|---|
| 2-week baseline | Experimental | Behavioral: Cognitive Behavioral Therapy for NightmaresParticipants will receive treatment after a 2-week baseline assessment period |
| 4-week baseline | Experimental | Behavioral: Cognitive Behavioral Therapy for NightmaresParticipants will receive treatment after a 4-week baseline assessment period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (6 listed)
- Possible dementia
- Narcolepsy
- Posttraumatic stress disorder
- Previous behavioral treatment for nightmares
- Currently engaged in sleep- or trauma-focused psychotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral Therapy for NightmaresAlso: Imagery Rehearsal TherapyThe 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. | Behavioural | 2-week baseline, 4-week baseline |
Primary outcome
Disturbing Dream and Nightmare Severity Index (DDNSI)
Time frame: Baseline and posttreatment
The DDNSI is a questionnaire which measures the severity of nightmares.
Nightmare frequency (sleep diary)
Time frame: Baseline and posttreatment
The number of nightmares experienced each day will be collected on daily sleep diaries completed during each assessment period.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy for Nightmares in people with Nightmare and Nightmare Disorder With Associated Other Sleep Disorder, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Mundt, PhD (801-646-8287, RBDstudy@utah.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disturbing Dream and Nightmare Severity Index (DDNSI) (time frame: Baseline and posttreatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.