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Cognitive Behavioral Therapy for PTSD

N/A
Recruiting
Led By Jean C Beckham, PhD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Is between 40-59 years old
Has a current diagnosis of chronic PTSD (at least 3 months duration) based on the Clinician Administered PTSD Scale DSM-5 version (Weathers et al., 2013);
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 6-month follow-up
Awards & highlights

Study Summary

This trial will study how insomnia affects people with PTSD who are at risk for cardiovascular disease.

Who is the study for?
This trial is for adults aged 40-59 with chronic PTSD and insomnia, without a history of cardiovascular events or severe mental health conditions like psychosis. Participants must not be pregnant, have restless leg syndrome, sleep apnea, or other major health issues that could interfere with the study.Check my eligibility
What is being tested?
The study tests if Cognitive Behavior Therapy for Insomnia can reduce cardiovascular risk in PTSD patients. It involves weekly phone check-ins to monitor progress and adherence to the therapy.See study design
What are the potential side effects?
Cognitive Behavioral Therapy for Insomnia generally has minimal side effects but may include temporary increases in anxiety or stress due to changes in sleeping habits.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 40 and 59 years old.
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I have been diagnosed with chronic PTSD for at least 3 months.
Select...
I am between 40 and 59 years old.
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I have been diagnosed with chronic PTSD for at least 3 months.
Select...
I have been diagnosed with insomnia disorder.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 6-month follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 6-month follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in 10-year atherosclerotic cardiovascular disease risk
Change in insomnia severity
Change in nighttime blood pressure
+4 more
Secondary outcome measures
Change in quality of life
Change in subjective sleep quality

Trial Design

2Treatment groups
Experimental Treatment
Group I: Minimal Contact Control ConditionExperimental Treatment1 Intervention
Participants assigned to this condition will be contacted every week for eight weeks and monitored regarding their insomnia symptoms.
Group II: Cognitive Behavior Therapy for Insomnia (CBT-I)Experimental Treatment1 Intervention
Participants assigned to this arm will receive eight sessions of a well-established, evidence-based therapy called cognitive behavior therapy for insomnia (CBT-I).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cognitive Behavior Therapy for Insomnia
2017
N/A
~50

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,360 Previous Clinical Trials
3,420,150 Total Patients Enrolled
Jean C Beckham, PhDPrincipal InvestigatorDuke Health
2 Previous Clinical Trials
173 Total Patients Enrolled
Andrew Sherwood, PhDPrincipal InvestigatorDuke Health
4 Previous Clinical Trials
666 Total Patients Enrolled

Media Library

Post-Traumatic Stress Disorder Research Study Groups: Minimal Contact Control Condition, Cognitive Behavior Therapy for Insomnia (CBT-I)
Post-Traumatic Stress Disorder Clinical Trial 2023: Cognitive Behavior Therapy for Insomnia Highlights & Side Effects. Trial Name: NCT04498754 — N/A
Cognitive Behavior Therapy for Insomnia 2023 Treatment Timeline for Medical Study. Trial Name: NCT04498754 — N/A

Frequently Asked Questions

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

Is anyone younger than 65 years old permitted to take part in the research?

"Patients aged between 40 and 59 are welcome to participate in the clinical trial. For those younger than 18, there is a separate cohort with 72 studies available; for people over 65, 568 trials have been put together."

Answered by AI

How many individuals are contributing to the research of this trial?

"Affirmative. The information hosted on clinicaltrials.gov demonstrates that this medical trial has been recruiting since March 15th 2021, with the most recent update being posted in March 21st 2022. This research endeavour is looking for 180 patients to be enrolled at a single location."

Answered by AI

Am I allowed to join this medical research program?

"To be accepted as a participant in this trial, applicants must have cardiovascular risk factors and should fall into the age range of 40-59. 180 individuals are required to complete the experiment."

Answered by AI

Does this experiment still have spots available for participants?

"Precisely. According to clinicaltrials.gov, this medical study has been actively recruiting since it was first posted on March 15th 2021 and requires 180 patients from one location for completion."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
What site did they apply to?
Duke University Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
Recent research and studies
clinicaltrials.govStudy
An Evaluation of Insomnia Treatment to Reduce Cardiovascular Risk in Patients With Posttraumatic Stress Disorder
2021. "An Evaluation of Insomnia Treatment to Reduce Cardiovascular Risk in Patients With Posttraumatic Stress Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04498754.
All > Sleep Disorders > Insomnia
~32 spots leftby Dec 2024
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