What side effects are associated with this type of intervention?

Common treatments for insomnia, such as Cognitive Behavioral Therapy for Insomnia (CBT-I) and Acceptance and Commitment Therapy (ACT), generally have minimal side effects compared to pharmacologic options. Patients may experience initial discomfort or increased anxiety as they adapt to new sleep routines and behavioral changes. The commitment to homework assignments and regular therapy sessions can also be challenging for some. Despite these minor issues, these therapies are well-tolerated and effective for long-term insomnia management.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of insomnia, including benzodiazepines (e.g., diazepam, lorazepam) and nonbenzodiazepine BZRAs (e.g., zolpidem, eszopiclone). These medications are effective in the short-term management of insomnia but come with potential side effects and risks, especially in long-term use. Nonpharmacologic treatments like Cognitive Behavioral Therapy for Insomnia (CBT-I) are also widely recognized for their efficacy in treating insomnia. While the combination of CBT-I with Acceptance and Commitment Therapy (ACT) is a promising approach being studied for its potential to improve treatment adherence and reduce symptoms in patients with comorbid PTSD and insomnia, it is not yet a standard FDA-approved treatment.

What other types of research exist?

Promising alternatives to ABC-I for treating insomnia in 2024 include: 1) Internet-delivered Cognitive Behavioral Therapy for Insomnia (CBT-I), which has shown long-term efficacy in improving sleep and daytime functioning. 2) Telephone-based CBT-I, which has been effective in reducing insomnia severity and improving sleep quality. 3) Hypnosis, which has shown potential benefits for reducing hot flashes and improving sleep, though more research is needed. 4) Mind-body-based therapies, such as mindfulness and relaxation techniques, which have shown promise in small studies. These alternatives offer various delivery methods and therapeutic approaches that can be tailored to individual patient needs.

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CBT vs ABC-I for Insomnia in PTSD

N/A

Recruiting

Led By Jennifer L Martin, 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

Have symptoms of insomnia

Have symptoms of PTSD

Must not have

Current participation in prolonged exposure therapy for PTSD

Unable to self-consent to participate

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6-months follow-up

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new treatment called ABC-I, which combines two types of therapy to help Veterans with PTSD and insomnia. The goal is to see if ABC-I can improve sleep and reduce PTSD symptoms better than the usual therapy. Veterans will receive several one-on-one sessions and be monitored for changes in their sleep and PTSD symptoms over a period of time.

Who is the study for?

Veterans over 18 living within 50 miles of the VA Sepulveda Ambulatory Care Center, who have PTSD and insomnia, and received VAGLAHS care in the past year. Excluded are those unable to consent, with unstable housing or medical conditions, pregnant or recent parents, active substance users/recently sober under 90 days, engaged in other PTSD therapies or with severe sleep disorders.

What is being tested?

The trial compares ABC-I (Acceptance and Behavioral Changes to treat Insomnia) with CBT-I (Cognitive-Behavioral Therapy for Insomnia) for Veterans having both PTSD and insomnia. Each participant will receive one of these treatments through five sessions to see which is more effective at reducing PTSD symptoms and improving sleep quality.

What are the potential side effects?

Since this trial involves behavioral therapy rather than medication, side effects may include discomfort from discussing personal experiences during therapy sessions but typically do not involve physical side effects like those associated with drugs.

Eligibility Criteria

Inclusion Criteria

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

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I have trouble sleeping.

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I experience symptoms of PTSD.

Select...

I experience symptoms of PTSD.

Select...

I have trouble sleeping.

Exclusion Criteria

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

Select...

I am currently undergoing prolonged exposure therapy for PTSD.

Select...

I am unable to give consent for myself.

Select...

I have severe sleep apnea that hasn't been treated.

Select...

My sleep problems are due to restless legs syndrome.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6-months follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6-months follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6-months 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

Insomnia Severity Index (ISI)

PTSD Check List for DSM-5 (PCL-5)

Pittsburgh Sleep Quality Index (PSQI)

+1 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: The ABC of Insomnia (Acceptance and the Behavioral Changes toExperimental Treatment1 Intervention

This is the new treatment arm that is being compared to CBT-I, standard treatment for insomnia.

Group II: Cognitive-Behavioral Therapy for InsomniaActive Control1 Intervention

This is the standard treatment for insomnia that is being compared to the new treatment (ABCI).

0 / 8Eligibility 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 insomnia, such as Cognitive Behavioral Therapy for Insomnia (CBT-I) and Acceptance and Commitment Therapy (ACT), work by addressing both behavioral and emotional components of the disorder. CBT-I focuses on changing sleep-related behaviors and thoughts through techniques like sleep restriction, stimulus control, and cognitive restructuring. ACT helps patients accept insomnia-related thoughts and feelings without letting them dictate behavior, emphasizing actions aligned with personal values. This dual approach can improve treatment adherence and outcomes by providing comprehensive management of insomnia symptoms.

Testing two types of self-help CBT-I for insomnia in older adults with arthritis or coronary artery disease.