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

Trial Summary

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.

What data supports the effectiveness of the treatment Intensive CBT for PTSD?

Research shows that intensive cognitive therapy for PTSD is as effective as weekly treatment, and cognitive-behavioral therapy (CBT) significantly improves PTSD symptoms, especially in those with severe PTSD. Additionally, intensive outpatient programs for PTSD, which include trauma-focused therapies, have high completion rates and effectively reduce PTSD symptoms. ^{1 2 3 4 5}

Is intensive CBT for PTSD safe for humans?

Research suggests that intensive trauma-focused cognitive behavioral therapy (CBT) for PTSD is generally safe, with very low rates of adverse events and only a few cases of symptom worsening. ^{2 6 7 8 9}

How is Intensive CBT for PTSD different from other treatments for PTSD?

Intensive CBT for PTSD, including iTCBT-G and iTCBT-I, is unique because it offers a concentrated and focused approach to therapy, often involving multiple sessions over a short period, which can lead to faster symptom reduction and improved treatment retention compared to traditional, less intensive therapies. ^{2 4 6 7 9}

What is the purpose of this trial?

The goal of this clinical trial is to compare two different intensive formats of delivering cognitive-behavioral treatment for people with PTSD and anxiety disorders. The main questions it aims to answer are: * Is iTCBT delivered in individual and group formats more effective than TAU in improving anxiety symptoms and quality of life? * For treatment non-responders, is iTCBT-Enhanced more effective than TAU improving anxiety symptoms and quality of life? * Does iTCBT-Individual produce a larger improvement in anxiety and quality of life compared with iTCBT-Group? Participants will undergo several assessments throughout the course of the study. Based on randomization, they will receive: (1) iTCBT in an individual format over a 2-week period, (2) iTCBT in a group format over a 2-day period, or (3) usual care. Those who do not show a response to treatment will receive 4 additional individual therapy sessions.

Research Team

Ellen Teng, PhD

Principal Investigator

Michael E. DeBakey VA Medical Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Intensive cognitive therapy for post-traumatic stress disorder in routine clinical practice: A matched comparison audit. [2018]

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

Clients' Experiences of Returning to the Trauma Site during PTSD Treatment: An Exploratory Study. [2018]

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

A randomized controlled trial of cognitive-behavioral treatment for posttraumatic stress disorder in severe mental illness. [2022]

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

Trauma-focused cognitive-behavioral therapy for children and adolescents: assessing the evidence. [2022]

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

Feasibility of an intensive outpatient treatment program for posttraumatic stress disorder within the veterans health care administration. [2023]

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

Asylum-seekers' experiences of trauma-focused cognitive behaviour therapy for post-traumatic stress disorder: a qualitative study. [2018]

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

Intensive prolonged exposure therapy for chronic PTSD patients following multiple trauma and multiple treatment attempts. [2020]

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

An intensive form of trauma focused cognitive behaviour therapy in an acute adolescent inpatient unit: An uncontrolled open trial. [2022]

9. Canada pubmed.ncbi.nlm.nih.gov

Acceptability of a Plasticity-Focused Serious Game Intervention for Posttraumatic Stress Disorder: User Requirements Analysis. [2020]