Treating Nightmares Among Domiciliary Patients

Nightmare Clinical Trial

Official title:

Treating Nightmares Among Veterans Health Administration Domiciliary Patients

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04341987
• Other study ID #: 1534869
• Status: Withdrawn
• Phase: N/A
• Start date: January 2021
• Est. completion date: June 2021

Study information

• Verified date: October 2020
• Source: Canandaigua VA Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Nightmare

Intervention

Behavioral:
• brief Imagery Rehearsal Therapy
Two-sessions of behaviorally-based imagery rehearsal therapy.

Other:
• Treatment As Usual
may include medication treatment or behavioral treatment for nightmares other than imagery rehearsal therapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Canandaigua VA Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.