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Computerized Cognitive Behavioral Therapy for Insomnia for Insomnia

Rocky Mountain Regional VAMC, Aurora, CO
Insomnia+1 More ConditionsComputerized Cognitive Behavioral Therapy for Insomnia - Behavioral
Eligibility
18 - 60
All Sexes

Study Summary

This trial will evaluate a computer-guided therapy for sleep disturbances caused by TBI, to see if it's more effective than existing treatments for those who may not have access to providers.

Eligible Conditions
  • Insomnia
  • Traumatic Brain Injury

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
N/A

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1
Symptom-specific Headache Treatment
3
Brief behavioral therapy for insomnia
1
Dyadic Intervention

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: Through study completion, an average of 9 weeks

Week 9
Insomnia Severity Index (ISI)
Week 9
Nature and duration of guidance needed to compete intervention
Two collection periods: One week prior to the start of the intervention and for the week immediately following completion of the intervention
Sleep efficiency - discrepancy between sleep diary and actigraphy
Sleep onset latency - discrepancy between sleep diary and actigraphy
Wake after sleep onset - discrepancy between sleep diary and actigraphy
Two timepoints: One week prior to the start of the intervention and for the week immediately following completion of the intervention
Total sleep time - discrepancy between sleep diary and actigraphy

Trial Safety

Phase-Based Safety

1 of 3

Similar Trials

1
Symptom-specific Headache Treatment
3
Brief behavioral therapy for insomnia
1
Dyadic Intervention

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

2 Treatment Groups

Enhanced Treatment as Usual
1 of 2
Computerized Cognitive Behavioral Therapy for Insomnia
1 of 2

Active Control

Experimental Treatment

80 Total Participants · 2 Treatment Groups

Primary Treatment: Computerized Cognitive Behavioral Therapy for Insomnia · No Placebo Group · N/A

Computerized Cognitive Behavioral Therapy for Insomnia
Behavioral
Experimental Group · 1 Intervention: Computerized Cognitive Behavioral Therapy for Insomnia · Intervention Types: Behavioral
Enhanced Treatment as UsualNoIntervention Group · 1 Intervention: Enhanced Treatment as Usual · Intervention Types:
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Computerized Cognitive Behavioral Therapy for Insomnia
2018
N/A
~350

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion, an average of 9 weeks

Who is running the clinical trial?

VA Eastern Colorado Health Care SystemLead Sponsor
50 Previous Clinical Trials
22,522 Total Patients Enrolled
Colorado Traumatic Brain Injury Trust FundOTHER
3 Previous Clinical Trials
2,018 Total Patients Enrolled
University of Colorado, DenverOTHER
1,644 Previous Clinical Trials
1,660,961 Total Patients Enrolled
5 Trials studying Insomnia
927 Patients Enrolled for Insomnia
Lisa A Brenner, PhDPrincipal InvestigatorRocky Mountain VA Mental Illness, Research, and Education Center
5 Previous Clinical Trials
2,052 Total Patients Enrolled

Eligibility Criteria

Age 18 - 60 · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You had a serious head injury with lasting effects at least one year ago.
You are currently experiencing trouble sleeping (insomnia).
References

Frequently Asked Questions

Does this trial permit those aged 35 and above to participate?

"This clinical trial requires participants to be between 18 - 60 years old, in accordance with the set eligibility criteria." - Anonymous Online Contributor

Unverified Answer

Are there any openings available to join this clinical endeavor?

"Clinicaltrials.gov specifies that this medical trial is currently enrolling subjects. The initial post was made on the 1st of July 2022 and recent modifications were applied on May 1st, 2023." - Anonymous Online Contributor

Unverified Answer

How many people are being recruited for this study?

"Affirmative, the clinicaltrials.gov registry shows that this research is actively seeking to enroll participants. The trial was initially posted on July 1st 2022 and has been newly updated as of May 1st 2023. Specifically, 80 individuals need to be recruited from a single medical centre." - Anonymous Online Contributor

Unverified Answer

Who meets the selection criteria for this research endeavor?

"80 individuals aged 18 to 60 with insomnia are eligible for this trial. To be considered, applicants must have experienced moderate or severe traumatic brain injury at least one year prior and possess the capabilities of accessing the web reliably, giving informed consent and dealing with current bouts of sleeplessness." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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