Intensive CBT for PTSD

Overseen By Terri Fletcher, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Baylor College of Medicine

Must be taking: Psychotropic

Disqualifiers: Mania, Psychosis, Suicidal ideation, others

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

Compensation: Varies

Number of Visits: 8

Duration: 2 weeks

306 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two methods of delivering intensive cognitive-behavioral therapy (CBT) for individuals with PTSD and anxiety disorders. It aims to determine whether CBT in individual or group formats can improve anxiety and life quality more effectively than usual care. Participants will be randomly assigned to receive either individual therapy sessions over two weeks, group therapy over two days, or continue with their usual treatment. Veterans or service members with a current anxiety disorder and moderate-to-poor life enjoyment may be suitable candidates for this study. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance future treatment options for anxiety disorders.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you must be stable on psychotropic medication for 4 weeks before participating. This suggests you can continue your current medications if they have been stable for that period.

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

Research has shown that intensive cognitive-behavioral therapy (CBT) effectively and safely treats PTSD. Studies have found that intensive CBT, whether in groups or individually, can improve PTSD symptoms and works as well as traditional weekly sessions. Most people find these treatments manageable.

For group-based intensive CBT, research on similar programs has demonstrated good satisfaction, high completion rates, and noticeable symptom improvement. Participants in these studies did not report significant negative effects, supporting the therapy's safety.

Similarly, individual-based intensive CBT has produced promising results. It significantly reduces symptoms, especially for conditions like panic disorder and PTSD. Like the group version, it is considered safe, with few negative effects reported.

Overall, both forms of intensive CBT in this trial appear to be safe options based on existing research. Participants can expect a well-tolerated experience with potential symptom improvements. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Intensive Transdiagnostic Cognitive Behavioral Therapy (iTCBT) for PTSD because it offers a more rapid and flexible approach compared to standard treatments like prolonged exposure therapy or conventional CBT. The iTCBT comes in two flavors: a group format (iTCBT-G) and an individual format (iTCBT-I), both designed to deliver the same therapeutic content but in different settings. These treatments are intensive, aiming to deliver results in just two weeks, which is notably quicker than traditional methods that often take several months. This approach not only focuses on alleviating PTSD symptoms but also targets other co-occurring mental health issues, thanks to its transdiagnostic nature. For patients who don't initially respond, there's an enhanced version offering additional sessions to further tailor the treatment to individual needs.

What evidence suggests that this trial's treatments could be effective for PTSD and anxiety disorders?

Research has shown that cognitive-behavioral therapy (CBT) effectively treats PTSD and anxiety. In this trial, participants will receive different forms of intensive CBT. The iTCBT-G arm involves group sessions, while the iTCBT-I arm provides individual sessions. Both approaches have greatly improved PTSD symptoms and overall quality of life. Additionally, methods effective for multiple disorders, such as anxiety and depression, have shown promising results. Overall, CBT is considered a top treatment for these conditions, and evidence supports its effectiveness. ^{1 3 5 6 7}

Who Is on the Research Team?

Ellen Teng, PhD

Principal Investigator

Michael E. DeBakey VA Medical Center

Are You a Good Fit for This Trial?

This trial is for veterans and service members over 18 with an anxiety disorder like PTSD, panic disorder, or social anxiety. They should have moderate-to-poor life satisfaction and be stable on any psychotropic medication for at least 4 weeks. Participants must be open to random treatment assignment.

Inclusion Criteria

I am willing to be assigned to a treatment group by chance.

I have been diagnosed with an anxiety disorder.

I have been on stable mental health medication for at least 4 weeks.

Exclusion Criteria

I do not have severe depression or thoughts of harming myself that would stop me from receiving treatment.

Moderate-to-severe cognitive impairment as indicated by the SLUMS (a score below 20)

I am currently experiencing symptoms of mania or psychosis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive iTCBT in either individual or group formats. Individual format involves 12 hours over 2 weeks, while group format involves 12 hours over 2 days.

2 weeks

4 visits (in-person) for individual format, 2 visits (in-person) for group format

Enhanced Treatment

For treatment non-responders, 4 additional 90-minute individual therapy sessions are provided over 2 weeks.

2 weeks

4 visits (in-person)

Follow-up

Participants are monitored for changes in anxiety and quality of life at 3- and 6-month intervals.

6 months

What Are the Treatments Tested in This Trial?

Interventions

• iTCBT-G
• iTCBT-I
• TAU
• Transdiagnostic Cognitive Behavioral Therapy

Trial Overview The study compares two intensive cognitive-behavioral therapies (iTCBT) in individual (over 2 weeks) and group formats (over 2 days), against usual care (TAU). It checks which method better improves symptoms of anxiety and quality of life. Non-responders get extra individual sessions.

How Is the Trial Designed?

Group I: iTCBT-I (Intensive Transdiagnostic Cognitive Behavioral Therapy-Individual) Experimental Treatment 1 Intervention

Patients in this arm will receive transdiagnostic CBT delivered in an intensive individual format over 2 weeks. Intensive Transdiagnostic Cognitive Behavior Therapy-Individual (iTCBT-I): Participants randomized to this condition will receive 12 hours of treatment in four 3 hour sessions, over a 2-week period. Treatment consists of psychoeducation, cognitive restructuring, and exposure exercises. For treatment non-responders (i.e., BAI score decrease \< 10), patients will receive 4 additional 90 minute sessions of individual therapy over a 2-week period (iTCBT-Enhanced). These sessions will identify areas where participants might benefit from more in-depth focus on specific concepts taught in the treatment.

Group II: iTCBT-G (Intensive Transdiagnostic Cognitive Behavioral Therapy-Group) Active Control 1 Intervention

Patients in this arm will receive transdiagnostic CBT delivered in an intensive group format over 2 weeks. Intensive Transdiagnostic Cognitive Behavior Therapy-Group (iTCBT-G): Participants randomized to this condition will receive 12 hours of treatment over a 2-day period (6 hrs each day). Treatment consists of psychoeducation, cognitive restructuring, and exposure exercises. For treatment non-responders (i.e., BAI score decrease \< 10), patients will receive 4 additional 90 minute sessions of individual therapy over a 2-week period (iTCBT-Enhanced). These sessions will identify areas where participants might benefit from more in-depth focus on specific concepts taught in the treatment.

Group III: Treatment as Usual (TAU) Active Control 1 Intervention

Patients in this arm will not receive transdiagnostic CBT but will receive treatment as usual, which may include other forms of psychotherapy and/or medication.

iTCBT-G is already approved in United States, European Union for the following indications:

Approved in United States as Cognitive Behavioral Therapy for:

• Post-Traumatic Stress Disorder (PTSD)
• Anxiety Disorders

Approved in European Union as Cognitive Behavioral Therapy for:

• Post-Traumatic Stress Disorder (PTSD)
• Anxiety Disorders

Who Is Running the Clinical Trial?

Baylor College of Medicine

Lead Sponsor

Trials

1,044

Recruited

6,031,000+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Published Research Related to This Trial

A randomized controlled trial involving 108 clients with PTSD and severe mental illness showed that cognitive-behavioral therapy (CBT) significantly improved PTSD symptoms compared to treatment as usual (TAU), with benefits lasting up to 6 months after treatment.

CBT was particularly effective for clients with severe PTSD, and factors like homework completion and changes in trauma-related beliefs were linked to greater symptom reductions, indicating that CBT can be a valuable intervention even for those with complex mental health challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of cognitive-behavioral treatment for posttraumatic stress disorder in severe mental illness. Mueser, KT., Rosenberg, SD., Xie, H., et al.[2022]

Intensive prolonged exposure (iPE) therapy significantly reduced PTSD symptoms in chronic patients, with a large effect size and 71% of participants showing a positive response after treatment, which persisted for at least six months.

The treatment was safe, with no dropouts during the intensive phase and only 5% during the booster phase, indicating high tolerability, and adverse events were minimal.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensive prolonged exposure therapy for chronic PTSD patients following multiple trauma and multiple treatment attempts. Hendriks, L., de Kleine, RA., Broekman, TG., et al.[2020]

Participants in trauma-focused cognitive behavioral therapy (TF-CBT) found site visits to the trauma location helpful, indicating that these visits can be an effective part of treatment for PTSD.

The study identified four key processes during site visits—facing fear, filling in gaps, learning from experiences, and perceiving the site differently—that contribute to a sense of closure, especially when supported by a therapist.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clients' Experiences of Returning to the Trauma Site during PTSD Treatment: An Exploratory Study. Murray, H., Merritt, C., Grey, N.[2018]

Intensive cognitive therapy for PTSD resulted in larger symptomatic improvements compared to standard weekly treatment, suggesting it may be a more effective option for some individuals.

Both treatment formats led to significant improvements in PTSD and depression measures, indicating that both approaches are beneficial, but the intensive format may cater better to certain patients based on their age and time since trauma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensive cognitive therapy for post-traumatic stress disorder in routine clinical practice: A matched comparison audit. Murray, H., El-Leithy, S., Billings, J.[2018]

A mobile phone-delivered serious game designed to enhance trauma-focused cognitive behavioral therapy (TF-CBT) for PTSD was found to be acceptable to both patients and clinicians, indicating potential for improved treatment engagement.

Both service users and clinicians suggested that the game should be therapist-guided and acknowledged that it may not be suitable for all patients, emphasizing the need for careful prescription by clinicians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptability of a Plasticity-Focused Serious Game Intervention for Posttraumatic Stress Disorder: User Requirements Analysis. Jones, M., Denisova, A., Mitchell, S., et al.[2020]

An intensive outpatient program (IOP) for PTSD, offering Prolonged Exposure and Cognitive Processing Therapy three or more times a week, achieved a high completion rate of 87.3% among veterans, indicating strong acceptability.

The IOP demonstrated significant effectiveness, with a large effect size (d = 1.80) in reducing PTSD symptoms, suggesting it is a promising treatment option to enhance engagement and outcomes in PTSD care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of an intensive outpatient treatment program for posttraumatic stress disorder within the veterans health care administration. Yamokoski, C., Flores, H., Facemire, V., et al.[2023]

Trauma-focused cognitive behavioral therapy (TFCBT) is generally accepted by asylum-seekers with PTSD, with most participants finding it helpful despite the challenges they faced during treatment.

Fear of repatriation can hinder engagement in TFCBT, highlighting the importance of a strong therapeutic relationship to support asylum-seekers in their recovery process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Asylum-seekers' experiences of trauma-focused cognitive behaviour therapy for post-traumatic stress disorder: a qualitative study. Vincent, F., Jenkins, H., Larkin, M., et al.[2018]

Trauma-Focused Cognitive-Behavioral Therapy (TF-CBT) is a highly effective treatment for reducing posttraumatic stress symptoms in children, supported by high-level evidence from ten randomized controlled trials (RCTs).

While TF-CBT shows promise in addressing trauma-related symptoms, its effectiveness in reducing behavioral problems and depression symptoms remains less certain, highlighting the need for further research to optimize its application across diverse populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trauma-focused cognitive-behavioral therapy for children and adolescents: assessing the evidence. de Arellano, MA., Lyman, DR., Jobe-Shields, L., et al.[2022]

An intensive form of trauma-focused cognitive behavior therapy (TF-CBT) was implemented for 15 adolescents with PTSD in an inpatient unit, showing significant improvements in PTSD symptoms and overall functioning after an average of nine sessions over 28 days.

The average PTSD symptom score decreased from 23.73 to 8.27, and the global functioning score improved from 19 to 48.7, indicating that TF-CBT can be effective in treating PTSD in hospitalized adolescents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An intensive form of trauma focused cognitive behaviour therapy in an acute adolescent inpatient unit: An uncontrolled open trial. Cabrera, N., Moffitt, G., Jairam, R., et al.[2022]

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