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Treating Nightmares Among Domiciliary Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04341987
Recruitment Status : Withdrawn (Covid-related)
First Posted : April 10, 2020
Last Update Posted : October 22, 2020
Information provided by (Responsible Party):
Canandaigua VA Medical Center

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.

Condition or disease Intervention/treatment Phase
Nightmare Behavioral: brief Imagery Rehearsal Therapy Other: Treatment As Usual Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treating Nightmares Among Veterans Health Administration Domiciliary Patients
Estimated Study Start Date : January 2021
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

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.

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

Primary Outcome Measures :
  1. 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.

  2. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04341987

Sponsors and Collaborators
Canandaigua VA Medical Center
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Principal Investigator: WIlfred R Pigeon, PhD Canandaigua VAMC
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Responsible Party: Canandaigua VA Medical Center Identifier: NCT04341987    
Other Study ID Numbers: 1534869
First Posted: April 10, 2020    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Canandaigua VA Medical Center:
substance use
imagery rehearsal therapy