CBT vs ABC-I for Insomnia in PTSD

Overseen by Jennifer L Martin, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: VA Office of Research and Development

Disqualifiers: Pregnancy, Substance use, Unstable disorders, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the treatment Cognitive-Behavioral Therapy for Insomnia (CBT-I) and Acceptance and the Behavioral Changes to treat Insomnia (ABC-I) for insomnia in PTSD?

Research shows that both CBT-I and ABC-I are effective for treating insomnia. CBT-I is a well-established treatment for insomnia, while ABC-I, which is based on acceptance and commitment therapy, has been shown to be similarly effective and may lead to better treatment adherence. ^{1 2 3 4 5}

Is CBT-I or ABC-I safe for treating insomnia in PTSD?

Cognitive Behavioral Therapy for Insomnia (CBT-I) is generally considered safe for treating insomnia, even when it occurs alongside other conditions. There is no specific safety data for Acceptance and Behavioral Changes for Insomnia (ABC-I), but similar therapies like Acceptance and Commitment Therapy (ACT) are also generally safe. ^{1 2 6 7 8}

How is the treatment CBT vs ABC-I for Insomnia in PTSD different from other treatments?

CBT-I (Cognitive Behavioral Therapy for Insomnia) and ABC-I (Acceptance and the Behavioral Changes to treat Insomnia) are unique because they focus on changing thought patterns and behaviors related to sleep, with ABC-I incorporating acceptance strategies to help patients manage insomnia. These treatments are particularly beneficial for individuals with PTSD, as they can improve sleep and prepare patients for further therapy, unlike standard drug treatments that may not address underlying psychological factors. ^{1 5 9 10 11}

Research Team

Jennifer L Martin, PhD

Principal Investigator

VA Greater Los Angeles Healthcare System, Sepulveda, CA

Eligibility Criteria

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.

Trial Timeline

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)

Treatment Details

Interventions

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

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.

Participant Groups

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).

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Dr. Grant Huang

VA Office of Research and Development

Acting Chief Research and Development Officer

PhD in Medical Psychology and Master of Public Health from the Uniformed Services University of Health Sciences

Dr. Erica M. Scavella

VA Office of Research and Development

Chief Medical Officer since 2022

MD from University of Massachusetts School of Medicine

Findings from Research

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]

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]

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 (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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Acceptance and Commitment Therapy as an Adjunct or Alternative Treatment to Cognitive Behavioral Therapy for Insomnia. [2023]

2. New Zealand 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. [2023]

3. United States 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. [2023]

4. England pubmed.ncbi.nlm.nih.gov

A Pilot Randomized Controlled Trial (RCT) of Acceptance and Commitment Therapy Versus Cognitive Behavioral Therapy for Chronic Insomnia. [2023]

5. United States 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. [2023]

6. England pubmed.ncbi.nlm.nih.gov

We know CBT-I works, now what? [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Therapy for Insomnia Comorbid With Psychiatric and Medical Conditions: A Meta-analysis. [2022]

8. England pubmed.ncbi.nlm.nih.gov

A non-inferiority randomized controlled trial comparing behavioral sleep interventions in women veterans: An examination of pain outcomes. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Cognitive behavioral therapy for insomnia as a preparatory treatment for exposure therapy for posttraumatic stress disorder. [2022]

10. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Cognitive-behavioral therapy and pharmacotherapy for chronic insomnia]. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of abbreviated CBT for insomnia in psychiatric outpatients: sleep and depression outcomes. [2022]