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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

Summary

This trial will compare a new treatment, ABC-I, to Cognitive Behavioral Therapy for Insomnia (CBT-I) among Veterans with comorbid Post-Traumatic Stress Disorder (PTSD) and insomnia disorder. ABC-I has been shown to improve treatment adherence and the study objectives are to evaluate the benefits of ABC-I in reducing PTSD symptoms and improving insomnia symptoms and sleep quality.

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.Check my eligibility
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.See study design
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.
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I experience symptoms of PTSD.
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I have trouble sleeping.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently undergoing prolonged exposure therapy for PTSD.
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I am unable to give consent for myself.
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I have severe sleep apnea that hasn't been treated.
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My sleep problems are due to restless legs syndrome.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Insomnia Severity Index (ISI)
PTSD Check List for DSM-5 (PCL-5)
Pittsburgh Sleep Quality Index (PSQI)
+1 more

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).

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.

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,628 Previous Clinical Trials
3,325,579 Total Patients Enrolled
26 Trials studying Insomnia
3,886 Patients Enrolled for Insomnia
Jennifer L Martin, PhDPrincipal InvestigatorVA Greater Los Angeles Healthcare System, Sepulveda, CA
1 Previous Clinical Trials
90 Total Patients Enrolled

Media Library

Cognitive-Behavioral Therapy for Insomnia Clinical Trial Eligibility Overview. Trial Name: NCT05194930 — N/A
Insomnia Research Study Groups: Cognitive-Behavioral Therapy for Insomnia, The ABC of Insomnia (Acceptance and the Behavioral Changes to
Insomnia Clinical Trial 2023: Cognitive-Behavioral Therapy for Insomnia Highlights & Side Effects. Trial Name: NCT05194930 — N/A
Cognitive-Behavioral Therapy for Insomnia 2023 Treatment Timeline for Medical Study. Trial Name: NCT05194930 — N/A
Insomnia Patient Testimony for trial: Trial Name: NCT05194930 — N/A
~141 spots leftby Jul 2025