CBT vs ABC-I for Insomnia in PTSD

Overseen By Diane I Lee, MSW

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Pregnancy, Substance use, Unstable disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 5 weeks

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new treatment, Acceptance of the Behavioral Changes to Treat Insomnia (ABC-I), is more effective than the usual Cognitive Behavioral Therapy for Insomnia (CBT-I) for Veterans with both PTSD and insomnia. ABC-I combines elements of CBT-I with another approach to enhance treatment adherence. Veterans with PTSD and insomnia who receive care at specific Los Angeles VA facilities might qualify. Participants will be randomly assigned to either ABC-I or CBT-I and will undergo several follow-ups to assess progress in PTSD symptoms and sleep quality. As an unphased trial, this study offers Veterans a unique opportunity to explore innovative treatments that could improve sleep and PTSD symptoms.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you have unstable medical or psychiatric disorders, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Acceptance and Behavioral Changes to Treat Insomnia (ABC-I) therapy could benefit Veterans with PTSD (post-traumatic stress disorder) and sleep difficulties. While specific safety data for ABC-I is not available, similar therapies like Acceptance and Commitment Therapy, a component of ABC-I, are generally well-tolerated, with few serious side effects. Cognitive Behavioral Therapy for Insomnia (CBT-I) is another well-established treatment safely used by many with sleep issues. These therapies aim to change thoughts and behaviors to improve sleep. As non-medication treatments, they avoid drug-related side effects. Overall, both ABC-I and CBT-I are considered safe and designed to enhance sleep without significant risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about The ABC of Insomnia (Acceptance and the Behavioral Changes to treat Insomnia) because it offers a fresh approach to managing insomnia in individuals with PTSD. Unlike traditional Cognitive-Behavioral Therapy for Insomnia (CBT-I), which focuses on changing sleep-related thoughts and behaviors, the ABC method emphasizes acceptance and behavioral adjustments. This novel approach could provide a more accessible and potentially effective alternative for those who struggle with the standard therapy. By focusing on acceptance, it may also reduce the pressure and stress often associated with trying to achieve perfect sleep, offering hope for better outcomes in PTSD-related insomnia.

What evidence suggests that this trial's treatments could be effective for insomnia in PTSD?

This trial will compare Cognitive-Behavioral Therapy for Insomnia (CBT-I) with The ABC of Insomnia (ABC-I) for treating insomnia in individuals with PTSD. Research has shown that ABC-I can help with insomnia and PTSD symptoms. One study found it to be as effective as CBT-I in improving sleep. ABC-I might also make it easier for patients to continue treatment. This new method combines elements of CBT-I with Acceptance and Commitment Therapy, which encourages accepting thoughts and feelings rather than fighting them. Overall, ABC-I appears promising for people dealing with both PTSD and sleep issues. ^{1 4 6 7 8}

Who Is on the Research Team?

Jennifer L Martin, PhD

Principal Investigator

VA Greater Los Angeles Healthcare System, Sepulveda, CA

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Live within a 50-mile radius of the research offices at the VA Sepulveda Ambulatory Care Center

I am a Veteran, 18 or older, and live in the community.

You have received care from VAGLAHS in the past year.

Exclusion Criteria

You don't have a stable place to live, making it hard for us to keep track of important medical equipment.

My insomnia symptoms have gone away before starting the trial.

I do not have any unstable medical or mental health conditions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either ABC-I or CBT-I treatment in 5 one-on-one sessions

5 weeks

5 visits (in-person)

Follow-up

Participants are monitored for PTSD symptoms, insomnia symptoms, and sleep quality post-treatment

6 months

3 follow-up assessments (post-treatment, 3-months, and 6-months after randomization)

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive-Behavioral Therapy for Insomnia
• The ABC of Insomnia (Acceptance and the Behavioral Changes to treat Insomnia)

Trial Overview 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.

How Is the Trial Designed?

Group I: The ABC of Insomnia (Acceptance and the Behavioral Changes to Experimental Treatment 1 Intervention

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

Group II: Cognitive-Behavioral Therapy for Insomnia Active Control 1 Intervention

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

Cognitive-Behavioral Therapy for Insomnia is already approved in United States for the following indications:

Approved in United States as CBT-I for:

• Insomnia disorder
• Comorbid insomnia and PTSD

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

Cognitive behavioral therapy for insomnia (CBT-I) is recognized as the first-line treatment for both uncomplicated insomnia and insomnia associated with other chronic disorders, demonstrating its broad efficacy.

This review aims to summarize efficacy data across various clinical and demographic factors and to outline future research and implementation strategies for CBT-I, highlighting its importance in treating sleep disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

We know CBT-I works, now what? Muench, A., Vargas, I., Grandner, MA., et al.[2022]

Both cognitive behavioral therapy for insomnia (CBTI) and acceptance and behavioral changes for insomnia (ABC-I) significantly reduced pain intensity and interference in 93 women veterans with comorbid insomnia and pain, showing that both treatments are effective.

ABC-I was found to be non-inferior to CBTI in improving pain outcomes, suggesting it is a viable alternative, while CBTI was more effective in reducing dysfunctional beliefs about sleep.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A non-inferiority randomized controlled trial comparing behavioral sleep interventions in women veterans: An examination of pain outcomes. Ravyts, SG., Erickson, AJ., Washington, DL., et al.[2023]

A study involving 149 women veterans with insomnia found that the novel treatment, acceptance and commitment therapy for insomnia (ABC-I), was as effective as cognitive behavioral therapy for insomnia (CBT-I) in improving sleep outcomes after treatment and at a 3-month follow-up.

ABC-I showed better adherence to some treatment elements compared to CBT-I, suggesting it may be a more acceptable option for women veterans seeking insomnia treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel treatment based on acceptance and commitment therapy versus cognitive behavioral therapy for insomnia: A randomized comparative effectiveness trial in women veterans. Martin, JL., Carlson, GC., Kelly, MR., et al.[2023]

In a study of 37 adults with chronic insomnia, both Acceptance and Commitment Therapy for Insomnia (ACT-I) and Cognitive Behavioral Therapy for Insomnia (CBT-I) significantly reduced insomnia severity, but CBT-I had a higher proportion of treatment responders immediately after treatment (64.7% vs. 50.0%).

Six months later, ACT-I showed continued improvement in insomnia severity, while the effectiveness of CBT-I slightly decreased, suggesting that ACT-I may offer longer-term benefits in managing insomnia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pilot Randomized Controlled Trial (RCT) of Acceptance and Commitment Therapy Versus Cognitive Behavioral Therapy for Chronic Insomnia. El Rafihi-Ferreira, R., Morin, CM., Hasan, R., et al.[2023]

Cognitive-behavioral therapy for insomnia (CBTi) was successfully used as a first-step treatment for a veteran with both insomnia and PTSD, leading to significant symptom relief after just six sessions.

The patient was able to transition to trauma-specific exposure therapy after CBTi, resulting in further reductions in both insomnia and PTSD symptoms, demonstrating the efficacy of this sequential treatment approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behavioral therapy for insomnia as a preparatory treatment for exposure therapy for posttraumatic stress disorder. Baddeley, JL., Gros, DF.[2022]

Cognitive-behavioral therapy for insomnia (CBT-I) showed positive effects on sleep quality and depressive symptoms in a study of 30 psychiatric outpatients, with 38% achieving normal sleep after treatment.

While CBT-I led to significant improvements within the treatment group over 4 and 8 weeks, there were no significant differences when compared to the control group, suggesting that while beneficial, the effects may not be strong enough to outperform standard care alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of abbreviated CBT for insomnia in psychiatric outpatients: sleep and depression outcomes. Wagley, JN., Rybarczyk, B., Nay, WT., et al.[2022]

Cognitive behavioral therapy for insomnia (CBT-I) significantly improves insomnia symptoms, with 36% of patients achieving remission compared to only 16.9% in control groups, indicating its efficacy for those with comorbid conditions.

CBT-I shows medium to large effect sizes for various sleep parameters, such as sleep efficiency and sleep onset latency, and has a small positive effect on comorbid symptoms, particularly benefiting patients with psychiatric conditions more than those with medical conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Therapy for Insomnia Comorbid With Psychiatric and Medical Conditions: A Meta-analysis. Wu, JQ., Appleman, ER., Salazar, RD., et al.[2022]

Cognitive Behavioral Therapy for Insomnia (CBT-I) is effective, but many patients struggle with sticking to the treatment, leading to early discontinuation.

Acceptance and Commitment Therapy (ACT) offers a promising alternative for treating insomnia, with unique components and mechanisms that may enhance adherence and effectiveness compared to traditional CBT-I.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptance and Commitment Therapy as an Adjunct or Alternative Treatment to Cognitive Behavioral Therapy for Insomnia. Saldaña, KS., McGowan, SK., Martin, JL.[2023]

Cognitive-behavioral therapy for insomnia (CBT-I) is the preferred treatment for chronic insomnia, but it faces challenges such as a lack of trained therapists and a low response rate among patients.

Alternative methods to CBT-I, including bibliotherapy, phone psychotherapy, brief behavioral therapy, and online CBT-I, are gaining interest, and hypnotics can be used alongside CBT-I to enhance its effectiveness or as a standalone treatment when CBT-I is not accessible.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cognitive-behavioral therapy and pharmacotherapy for chronic insomnia]. Pchelina, PV., Poluektov, MG.[2019]

Acceptance and Commitment Therapy (ACT) was found to significantly improve sleep quality and reduce anxiety in patients with chronic primary insomnia, showing particular effectiveness in those with high anxiety about sleep problems.

In a study of 30 patients over four weeks, both ACT and Cognitive Behavior Therapy for Insomnia (CBT-I) improved insomnia symptoms, but only ACT led to a significant reduction in anxiety, suggesting it may be a valuable alternative for patients who do not respond to CBT-I.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Acceptance and Commitment Therapy (ACT) and Cognitive Behavior Therapy (CBT) for Chronic Insomnia: A Pilot Randomized Controlled Trial. Shin, JW., Kim, S., Shin, YJ., et al.[2023]

Cognitive behavioral therapy for insomnia (CBT-I) was effective for veterans during the early months of the COVID-19 pandemic, with an average decrease of 9.9 points in Insomnia Severity Index scores and a 66% response rate among participants.

The effectiveness of CBT-I was similar whether delivered in-person or entirely via telehealth, demonstrating its adaptability and efficacy in challenging circumstances.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In-person and telehealth treatment of veterans with insomnia disorder using cognitive behavioral therapy for insomnia during the COVID-19 pandemic. Martin, JL., DeViva, J., McCarthy, E., et al.[2023]

Citations

1. academic.oup.com academic.oup.com/sleep/article/48/Supplement_1/A254/8135951

Treatment Effects in Women Veterans with Probable PTSD ABC-I holds promise for addressing insomnia and PTSD symptoms in trauma-exposed individuals, a population that has historically demonstrated sub-optimal ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37535521/

A randomized comparative effectiveness trial in women veterans Overall, ABC-I was similar in effectiveness compared to CBT-I for the treatment of insomnia and may improve adherence to some behavioral ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10592426/

A Randomized Comparative Effectiveness Trial in Women ... Conclusions: Overall, ABC-I was similar in effectiveness compared to CBT-I for treatment of insomnia and may improve adherence to some behavioral elements of ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0005789425000206

Insomnia Symptom Improvement as a Mediator for Mental ... This study examined change in insomnia severity as a mediator of mental health symptom improvements in women veterans following behavioral insomnia treatment.

5. researchgate.net researchgate.net/publication/391863406_0583_Acceptance_and_Behavioral_Changes_to_Treat_Insomnia_ABC-I_Treatment_Effects_in_Women_Veterans_with_Probable_PTSD

Treatment Effects in Women Veterans with Probable PTSD Introduction Acceptance and Behavioral Changes to Treat Insomnia (ABC-I) is a promising acceptance- and behavioral-based intervention for the treatment of ...

6. hsrd.research.va.gov hsrd.research.va.gov/research/abstracts.cfm?Project_ID=2141707878

IIR 20-283 – HSR Study - VA Health Systems Research Our preliminary work suggests ABC-I is highly effective for Veterans with PTSD. Significance/Impact: Poor sleep is experienced by up to 90% of individuals with ...

7. withpower.com withpower.com/trial/phase-sleep-initiation-and-maintenance-disorders-5-2022-4f1a1

CBT vs ABC-I for Insomnia in PTSD There is no specific safety data for Acceptance and Behavioral Changes for Insomnia (ABC-I), but similar therapies like Acceptance and Commitment Therapy ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1049386725001094

Black Women Benefit From Psychotherapies for Insomnia ... As part of a larger clinical trial (NCT02076165), 40 Black and 51 white women veterans with insomnia disorder completed 5-sessions of CBT-I or ...