NCT04341987

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

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2021

Shorter than P25 for not_applicable

Status
withdrawn

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

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 10, 2020

Completed
9 months until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

October 22, 2020

Status Verified

October 1, 2020

Enrollment Period

5 months

First QC Date

April 7, 2020

Last Update Submit

October 20, 2020

Conditions

Keywords

nightmarestreatmentsubstance useimagery rehearsal therapy

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

EXPERIMENTAL

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

Treatment As Usual

OTHER

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

Interventions

Two-sessions of behaviorally-based imagery rehearsal therapy.

brief Imagery Rehearsal Therapy

may include medication treatment or behavioral treatment for nightmares other than imagery rehearsal therapy

Treatment As Usual

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Substance-Related Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • WIlfred R Pigeon, PhD

    Canandaigua VAMC

    PRINCIPAL INVESTIGATOR
0

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.