What is the mechanism of action of this treatment?

Common treatments for PTSD, such as Cognitive Behavioral Therapy for Insomnia (CBT-I) and sleep hygiene education, work by addressing the maladaptive thoughts and behaviors that contribute to poor sleep. CBT-I uses techniques like stimulus control, sleep restriction, and cognitive restructuring to improve sleep patterns. Sleep hygiene education focuses on establishing regular sleep-wake schedules, reducing screen time before bed, and creating a conducive sleep environment. These interventions are crucial for PTSD patients as they help break the cycle of anxiety and poor sleep, thereby reducing PTSD symptoms and improving overall quality of life.

What side effects are associated with this type of intervention?

Non-pharmacological treatments for PTSD, such as Cognitive Behavioral Therapy for Insomnia (CBT-I) and sleep hygiene education, are generally well-tolerated with minimal side effects. The most common side effects include temporary increases in anxiety or stress as individuals confront and modify their sleep habits. Some patients may experience initial difficulty adhering to new sleep schedules or restrictions, which can lead to short-term sleep disturbances. However, these side effects are typically mild and transient, with long-term benefits outweighing initial discomfort.

What prior FDA approvals exist?

The FDA has approved several pharmacological treatments for PTSD, including selective serotonin reuptake inhibitors (SSRIs) like sertraline and paroxetine. However, non-pharmacological interventions such as Cognitive Behavioral Therapy for Insomnia (CBT-I) and sleep hygiene education, which are being studied in the Behavioral Sleep Treatment trial, are also effective. These therapies focus on improving sleep patterns and quality, addressing both insomnia and PTSD symptoms without the use of medication. Such behavioral treatments have shown significant benefits in reducing insomnia severity and improving overall sleep quality in individuals with PTSD.

What other types of research exist?

Promising, novel alternatives to traditional behavioral sleep treatments for PTSD patients in 2024 include Cognitive Behavioral Social Rhythm Therapy (CBSRT), Brief Behavioral Treatment for Insomnia (BBTI), and digital or internet-delivered Cognitive Behavioral Therapy for Insomnia (CBT-I). These interventions offer flexible, accessible, and potentially effective options for improving sleep patterns and quality in PTSD patients.

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AIR Sleep Treatment for PTSD-related Sleep Disorders (AIR Trial)

Phase 2

Waitlist Available

Led By Lizabeth A Goldstein, 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

Meet DSM-5 Criteria for Posttraumatic Stress Disorder or subthreshold Posttraumatic Stress Disorder

Veterans diagnosed with sleep apnea with Apnea Hypopnea Index of at least 5 via sleep study and recommended for PAP therapy

Must not have

Prominent suicidal or homicidal ideation requiring alternative treatment for patient safety

Timeline

Screening 3 weeks

Treatment Varies

Follow Up past 7 days, at 3 months after treatment ends

Awards & highlights

No Placebo-Only Group

Summary

This trial uses video calls to help veterans with PTSD, sleep apnea, and insomnia improve their sleep and daily functioning. The main goal is to enhance their quality of life by teaching better sleep habits. Veterans will also give feedback on how practical and acceptable they find the treatment.

Who is the study for?

This trial is for Veterans with both sleep apnea and insomnia, who also have PTSD or subthreshold PTSD. Participants must be diagnosed with sleep apnea (Apnea Hypopnea Index of at least 5) and recommended for PAP therapy. They should be willing to attend all sessions, read English well enough for treatment, and not have plans that interfere with regular attendance.

What is being tested?

The study is testing a behavioral sleep treatment called Apnea and Insomnia Relief (AIR), compared to Sleep Education (SE). The goal is to see if AIR can improve functioning and sleep quality in Veterans suffering from PTSD.

What are the potential side effects?

Since the interventions are behavioral treatments rather than medications, there may not be traditional side effects. However, participants might experience discomfort or changes in their sleeping patterns as they adjust to new behaviors taught during the treatments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with PTSD or have symptoms of PTSD.

Select...

I am a veteran diagnosed with sleep apnea and advised to use a PAP machine.

Exclusion Criteria

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

Select...

I have severe thoughts of harming myself or others.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ past 7 days, at 3 months after treatment ends

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~past 7 days, at 3 months after treatment ends

This trial's timeline: 3 weeks for screening, Varies for treatment, and past 7 days, at 3 months after treatment ends for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

World Health Organization Quality of Life (WHOQOL-BREF)

Secondary study objectives

CPAP Adherence

Clinician Administered PTSD Scale for DSM-5 (CAPS-5)

Functional Outcomes of Sleep Questionnaire (FOSQ-10)

+2 more

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

Active Control

Group I: Apnea and Insomnia Relief (AIR)Experimental Treatment1 Intervention

This treatment will be offered over six sessions. All appointments will be conducted via telehealth and will last 60 minutes. The main components of the AIR protocol are (a) psychoeducation, (b) motivational interviewing, (c) PAP adherence strategies, and (d) cognitive behavioral therapy for insomnia.

Group II: Sleep Education (SE)Active Control1 Intervention

This treatment will be offered over six sessions. All appointments will be conducted via telehealth and will last 60 minutes. Topics covered include the sleep cycle, sleep across the lifespan, sleep and the mind, evening activities and the sleep environment, and daytime activities and sleep.

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for PTSD, such as Cognitive Behavioral Therapy for Insomnia (CBT-I) and sleep hygiene education, work by addressing the maladaptive thoughts and behaviors that contribute to poor sleep. CBT-I uses techniques like stimulus control, sleep restriction, and cognitive restructuring to improve sleep patterns. Sleep hygiene education focuses on establishing regular sleep-wake schedules, reducing screen time before bed, and creating a conducive sleep environment. These interventions are crucial for PTSD patients as they help break the cycle of anxiety and poor sleep, thereby reducing PTSD symptoms and improving overall quality of life.