Treating Nightmares Among Domiciliary Patients

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.

Study Overview

• Status: Withdrawn
• Conditions: Nightmare
• Intervention / Treatment: Behavioral: brief Imagery Rehearsal Therapy; Other: Treatment As Usual

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 Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: brief Imagery Rehearsal Therapy; 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.	Behavioral: brief Imagery Rehearsal Therapy; Two-sessions of behaviorally-based imagery rehearsal therapy.
Other: Treatment As Usual; Patients in this condition are free to receive treatment as usual for nightmares, which may be a medication, supportive counseling or no treatment.	Other: Treatment As Usual; may include medication treatment or behavioral treatment for nightmares other than imagery rehearsal therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Canandaigua VA Medical Center
• Investigators: Principal Investigator: WIlfred R Pigeon, PhD, Canandaigua VAMC

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2021
• Primary Completion (Anticipated): June 1, 2021
• Study Completion (Anticipated): June 1, 2021

Study Registration Dates

• First Submitted: April 7, 2020
• First Submitted That Met QC Criteria: April 9, 2020
• First Posted (Actual): April 10, 2020

Study Record Updates

• Last Update Posted (Actual): October 22, 2020
• Last Update Submitted That Met QC Criteria: October 20, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: treatment; nightmares; substance use; imagery rehearsal therapy
• Other Study ID Numbers: 1534869

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No