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Behavioral Intervention

Cognitive Symptom Management for Insomnia (Sleep-SMART Trial)

N/A
Waitlist Available
Led By Erin Almklov, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
DSM-5 diagnosis of insomnia and an Insomnia Severity Index (ISI) score >7 at baseline
Veterans ages 60 or older who are competent to provide informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up immediately before and immediately after the intervention
Awards & highlights

Sleep-SMART Trial Summary

This trial will develop and test a new treatment for insomnia that incorporates principles of cognitive symptom management and rehabilitation therapy to help those with mild cognitive impairment.

Who is the study for?
This trial is for Veterans aged 60 or older with mild cognitive impairment (MCI) and chronic insomnia, who can consent to the study. They must have an Insomnia Severity Index score over 7, speak English, and have no major sensory impairments. Those with other sleep disorders, severe brain injuries, dementia, psychotic disorders, substance use disorders or high suicidality risk are excluded.Check my eligibility
What is being tested?
Sleep-SMART combines Cognitive Behavioral Therapy for Insomnia (CBT-I) with Cognitive Symptom Management and Rehabilitation Therapy (CogSMART). It's designed to help Veterans with MCI by providing supportive strategies aimed at improving sleep treatment adherence and outcomes.See study design
What are the potential side effects?
Since Sleep-SMART is a non-pharmacological intervention involving therapy sessions rather than medication, side effects may include discomfort from discussing personal issues but typically do not involve physical symptoms.

Sleep-SMART Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with insomnia and my insomnia is moderate to severe.
Select...
I am a veteran aged 60 or older and can make my own medical decisions.

Sleep-SMART Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediately before and immediately after the intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately before and immediately after the intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Acceptability of Intervention Measure (AIM)
Client Satisfaction Questionnaire (CSQ-8)
Feasibility of Intervention Measure (FIM)
+2 more
Secondary outcome measures
Brief Visuospatial Memory Test-Revised
Delis-Kaplan Executive Function System (D-KEFS) Trail Making Test
Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency Test
+9 more

Sleep-SMART Trial Design

1Treatment groups
Experimental Treatment
Group I: Sleep-SMARTExperimental Treatment1 Intervention
Sleep-SMART intervention

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,306,578 Total Patients Enrolled
26 Trials studying Insomnia
4,172 Patients Enrolled for Insomnia
Erin Almklov, PhDPrincipal InvestigatorVA San Diego Healthcare System, San Diego, CA

Media Library

Sleep-SMART (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05016960 — N/A
Insomnia Research Study Groups: Sleep-SMART
Insomnia Clinical Trial 2023: Sleep-SMART Highlights & Side Effects. Trial Name: NCT05016960 — N/A
Sleep-SMART (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05016960 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the intended aim of this clinical research?

"The main outcome measure to be assessed shortly after the intervention is the Feasibility of Intervention Measure (FIM). Additionally, evaluations will include Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency Test - a performance based assessment that uses word generation as its metric. This score will then be transformed into an age-based scaled rate with higher scores indicating better results. Other metrics are Everyday Cognition Scale (ECoG), which involves 39 questions related to cognitive function and dementia diagnosis; and Pittsburgh Sleep Quality Index (PSQI) – a 0–3 self-reported test measuring sleep quality over one"

Answered by AI

Are there any opportunities to be involved in this research presently?

"According to the information available on clinicaltrials.gov, this experiment is actively recruiting participants. The trial details were posted for public view on April 1st 2022 and recently edited in December of that same year."

Answered by AI

How many participants are actively signing up for this experiment?

"Indeed, the protocol that is hosted on clinicaltrials.gov reveals this medical trial's ongoing search for participants. Initially posted in January 4th 2022, and modified as recently as December 1st of the same year, it requires 31 volunteers at a single site."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What state do they live in?
California
What site did they apply to?
VA San Diego Healthcare System, San Diego, CA

Why did patients apply to this trial?

Feeling exhausted all the time.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Sleep-SMART for Veterans
2022. "Sleep-SMART for Veterans". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05016960.
~8 spots leftby Apr 2025
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