Study Stopped
Covid-related
Treating Nightmares Among Domiciliary Patients
Treating Nightmares Among Veterans Health Administration Domiciliary Patients
1 other identifier
interventional
N/A
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jan 2021
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 7, 2020
CompletedFirst Posted
Study publicly available on registry
April 10, 2020
CompletedStudy Start
First participant enrolled
January 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2021
CompletedOctober 22, 2020
October 1, 2020
5 months
April 7, 2020
October 20, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Nightmare Frequency
Disturbing Dreams and Nightmares Severity Index. The score for frequency ranges from 0-7.
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.
Change in nigthmare severity from baseline to 8 week follow-up.
Study Arms (2)
brief Imagery Rehearsal Therapy
EXPERIMENTALThe 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
OTHERPatients in this condition are free to receive treatment as usual for nightmares, which may be a medication, supportive counseling or no treatment.
Interventions
Two-sessions of behaviorally-based imagery rehearsal therapy.
may include medication treatment or behavioral treatment for nightmares other than imagery rehearsal therapy
Eligibility Criteria
You may qualify if:
- English-speaking
- endorses nightmares at least once a week
- score of 10 or greater on the Disturbing Dreams and Nightmares Severity Index
You may not qualify if:
- unable to consent
- diagnosis of serious mental illness (schizophrenia, schizoaffective disorder)
- active suicide ideation with plan and intent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
WIlfred R Pigeon, PhD
Canandaigua VAMC
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 7, 2020
First Posted
April 10, 2020
Study Start
January 1, 2021
Primary Completion
June 1, 2021
Study Completion
June 1, 2021
Last Updated
October 22, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will not share
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.