NightmareNCT04341987
Treating Nightmares Among Domiciliary Patients
A study testing brief Imagery Rehearsal Therapy and Treatment As Usual in people with Nightmare, run by Canandaigua VA Medical Center.
Trial summary
The purpose of the study is to assess the efficacy of a 2-session intervention to reduce nightmares among Veterans admitted VA mental health residential rehabilitation treatment programs. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nightmare
- What is being tested?
- brief Imagery Rehearsal Therapy and Treatment As Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2021to Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- English-speaking
- endorses nightmares at least once a week
- score of 10 or greater on the Disturbing Dreams and Nightmares Severity Index
Who cannot join
- unable to consent
- diagnosis of serious mental illness (schizophrenia, schizoaffective disorder)
- active suicide ideation with plan and intent
About this study
Official title: Treating Nightmares Among Veterans Health Administration Domiciliary Patients
The purpose of the study is to assess the efficacy of a 2-session intervention to reduce nightmares among Veterans admitted VA mental health residential rehabilitation treatment programs.
Read the detailed description
Sleep disturbances and suicide are highly prevalent among Veterans and recent research also suggests high comorbid rates of sleep and suicide in Veterans discharged from VA mental health residential rehabilitation treatment programs (MHRRTP; domiciliaries). Nightmares are a frequent concern identified by MHRRTP patients and are a modifiable risk factor for suicide risk. Little is known, however, about the treatment of nightmares and subsequent impact in this setting. The primary aims of the present project are to investigate the efficacy and acceptability of delivering a 2-session intervention to reduce nightmares among Veterans admitted to a MHRRTP. This study will examine this intervention's impact on reducing nightmare distress and nightmare frequency, as well as assess treatment acceptability. Changes in suicide risk following intervention will also be explored. This research will be conducted within the Canandaigua and Bath VA domiciliary programs which currently accommodate ~150-175 Veterans. The study will be a randomized control trial with a hybrid design that uses stratification based on prescription use and randomly assigns individuals (N = 48) to either the treatment group or treatment as usual group (TAU). Veterans referred for the protocol will be screened for eligibility and then if appropriate, scheduled for a baseline evaluation, randomized to either the treatment group or TAU group, seen for two intervention sessions one week apart, and then be followed up with 4- and 8-weeks post initial treatment via telephone. This research has potential to highlight valuable targets for cross-cutting treatment in a rehabilitation setting that can be delivered in civilian and Veteran samples.
- Conditions
- Nightmare
- Being tested
- brief Imagery Rehearsal Therapy, Treatment As Usual
- Keywords
- nightmares, treatment, substance use, imagery rehearsal therapy
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
brief Imagery Rehearsal TherapyBehavioural
Two-sessions of behaviorally-based imagery rehearsal therapy.
Treatment As UsualOther
may include medication treatment or behavioral treatment for nightmares other than imagery rehearsal therapy
| Study group | Role | What they receive |
|---|---|---|
| brief Imagery Rehearsal Therapy | Experimental | The brief two-session, behaviorally-based imagery rehearsal intervention is based on components from previous group and individual formats that have been published, but will be presented in an abbreviated manner. In the first session, Veterans will be presented with psychoeducation about dreaming, basics of sleep hygiene and stimulus control techniques, how to change negative dreams from a "learned habit" perspective, re-scripting, and how to rehearse new dream imagery. They will then be asked to complete in-session practice of imagery rehearsal with the new imagery developed. Veteran will be instructed in practice post-session. Receives: Behavioral: brief Imagery Rehearsal Therapy |
| Treatment As Usual | Other | Patients in this condition are free to receive treatment as usual for nightmares, which may be a medication, supportive counseling or no treatment. Receives: Other: Treatment As Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nightmare Frequency
Disturbing Dreams and Nightmares Severity Index. The score for frequency ranges from 0-7.
Measured: Change in total nights with nigthmares in the past week from baseline to 8 week follow-up.
Nightmare Severity
Disturbing Dreams and Nightmares Severity Index. The score for severity ranges from 0-6.
Measured: Change in nigthmare severity from baseline to 8 week follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2020
- Study startJan 2021 (estimated)
- Primary completionJun 2021 (estimated)
- Study completionJun 2021 (estimated)
Why it stopped: Covid-related
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
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Canandaigua VA Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- WIlfred R Pigeon, PhD, Principal investigator, Canandaigua VAMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04341987
- Sponsor's protocol ID
- 1534869
- Status last verified
- Oct 2020
- First submitted
- 7 Apr 2020
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Because the potential participant pool is relatively small (inpatients in a specific location during a specific time period) individuals are potentially identifiable even if data are de-identified.
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Nightmares Among Veterans Health Administration Domiciliary Patients
- ClinicalTrials.gov ID
- NCT04341987
- Acronym / sponsor ID
- 1534869
- Conditions
- Nightmare
- Keywords
- nightmares, treatment, substance use, imagery rehearsal therapy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Covid-related
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Canandaigua VA Medical CenterUS federal agency
- Study start
- Jan 2021 (estimated)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 10 Apr 2020 (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 the study is to assess the efficacy of a 2-session intervention to reduce nightmares among Veterans admitted VA mental health residential rehabilitation treatment programs.
Detailed description
Sleep disturbances and suicide are highly prevalent among Veterans and recent research also suggests high comorbid rates of sleep and suicide in Veterans discharged from VA mental health residential rehabilitation treatment programs (MHRRTP; domiciliaries). Nightmares are a frequent concern identified by MHRRTP patients and are a modifiable risk factor for suicide risk. Little is known, however, about the treatment of nightmares and subsequent impact in this setting. The primary aims of the present project are to investigate the efficacy and acceptability of delivering a 2-session intervention to reduce nightmares among Veterans admitted to a MHRRTP. This study will examine this intervention's impact on reducing nightmare distress and nightmare frequency, as well as assess treatment acceptability. Changes in suicide risk following intervention will also be explored. This research will be conducted within the Canandaigua and Bath VA domiciliary programs which currently accommodate ~150-175 Veterans. The study will be a randomized control trial with a hybrid design that uses stratification based on prescription use and randomly assigns individuals (N = 48) to either the treatment group or treatment as usual group (TAU). Veterans referred for the protocol will be screened for eligibility and then if appropriate, scheduled for a baseline evaluation, randomized to either the treatment group or TAU group, seen for two intervention sessions one week apart, and then be followed up with 4- and 8-weeks post initial treatment via telephone. This research has potential to highlight valuable targets for cross-cutting treatment in a rehabilitation setting that can be delivered in civilian and Veteran samples.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| brief Imagery Rehearsal Therapy | Experimental | Behavioral: brief Imagery Rehearsal TherapyThe brief two-session, behaviorally-based imagery rehearsal intervention is based on components from previous group and individual formats that have been published, but will be presented in an abbreviated manner. In the first session, Veterans will be presented with psychoeducation about dreaming, basics of sleep hygiene and stimulus control techniques, how to change negative dreams from a "learned habit" perspective, re-scripting, and how to rehearse new dream imagery. They will then be asked to complete in-session practice of imagery rehearsal with the new imagery developed. Veteran will be instructed in practice post-session. |
| Treatment As Usual | Other | Other: Treatment As UsualPatients in this condition are free to receive treatment as usual for nightmares, which may be a medication, supportive counseling or no treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- English-speaking
- endorses nightmares at least once a week
- score of 10 or greater on the Disturbing Dreams and Nightmares Severity Index
Key exclusion criteria (3 listed)
- unable to consent
- diagnosis of serious mental illness (schizophrenia, schizoaffective disorder)
- active suicide ideation with plan and intent
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 |
|---|---|---|
| brief Imagery Rehearsal TherapyTwo-sessions of behaviorally-based imagery rehearsal therapy. | Behavioural | brief Imagery Rehearsal Therapy |
| Treatment As Usualmay include medication treatment or behavioral treatment for nightmares other than imagery rehearsal therapy | Other | Treatment As Usual |
Primary outcome
Nightmare Frequency
Time frame: Change in total nights with nigthmares in the past week from baseline to 8 week follow-up.
Disturbing Dreams and Nightmares Severity Index. The score for frequency ranges from 0-7.
Nightmare Severity
Time frame: Change in nigthmare severity from baseline to 8 week follow-up.
Disturbing Dreams and Nightmares Severity Index. The score for severity ranges from 0-6.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- Individual participant dataSharing planned: No. Because the potential participant pool is relatively small (inpatients in a specific location during a specific time period) individuals are potentially identifiable even if data are de-identified.
Related trials for Nightmare
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Nightmare Deconstruction and Reprocessing vs. NightWare Wristband
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Recruiting
Validation of an Algorithm for Predicting Awakenings Associated With Trauma-related Nightmares, Based on the Analysis of Physiological Patterns in Military and Former Military Patients Suffering From Post-traumatic Stress Disorder
PTSD - Post Traumatic Stress Disorder, Trauma-related Nightmares
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A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
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Predicting Responses to PTSD Treatment With Iris and Cardiovascular Tests
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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. This study is not recruiting at the moment.
WIlfred R Pigeon, PhD principal investigator
Canandaigua VAMC
Questions about this trial
What is this clinical trial studying?
A study testing brief Imagery Rehearsal Therapy and Treatment As Usual in people with Nightmare, run by Canandaigua VA Medical Center.
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 3 inclusion and 3 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: withdrawn, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nightmare Frequency (time frame: Change in total nights with nigthmares in the past week from baseline to 8 week follow-up.). 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 22 Oct 2020.