Clinical trial NCT04341987: Treating Nightmares Among Domiciliary Patients
Official title: Treating Nightmares Among Veterans Health Administration Domiciliary Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Nightmare
Keywords: nightmares
treatment
substance use
imagery rehearsal therapy
Lead sponsor: Canandaigua VA Medical Center
Sponsor class: FED
First posted: 2020-04-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* English-speaking
* endorses nightmares at least once a week
* score of 10 or greater on the Disturbing Dreams and Nightmares Severity Index

Exclusion Criteria:

* unable to consent
* diagnosis of serious mental illness (schizophrenia, schizoaffective disorder)
* active suicide ideation with plan and intent

Primary outcomes:
measure: Nightmare Frequency
timeFrame: Change in total nights with nigthmares in the past week from baseline to 8 week follow-up.
measure: Nightmare Severity
timeFrame: Change in nigthmare severity from baseline to 8 week follow-up.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Canandaigua VAMC
name: WIlfred R Pigeon, PhD
role: PRINCIPAL_INVESTIGATOR
References: