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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);

Must not have

Has seizures (based on clinical interview and self-report)

Has a history of CVD events, including myocardial infarction, stroke, transient ischemic attack, or coronary revascularization

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 6-month follow-up

Awards & highlights

No Placebo-Only Group

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.

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.

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.

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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.

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I have been diagnosed with insomnia disorder.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I experience seizures.

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I have had a heart attack, stroke, or surgery to improve blood flow to my heart.

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I have been diagnosed with heart failure or heart disease.

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I have been diagnosed with sleep apnea.

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I have severe hearing or speech difficulties.

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My BMI is 45 or higher.

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My sleep issues are due to a medical condition that can't be fixed by changing my behavior.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 6-month follow-up

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in 10-year atherosclerotic cardiovascular disease risk

Change in insomnia severity

Change in nighttime blood pressure

+4 more

Secondary study objectives

Change in quality of life

Change in subjective sleep quality

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 12Eligibility criteria met