Trial Summary
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.
Is Intensive CBT a promising treatment for PTSD?Yes, Intensive CBT is a promising treatment for PTSD. It is based on strong evidence and is effective in reducing PTSD symptoms. It is especially helpful for people who have experienced multiple traumas and have tried other treatments without success. Many people respond well to this treatment, and it is considered safe.23467
Do I have to stop taking my current medications for the trial?The trial protocol does not specify if you need to stop taking your current medications. However, you must be stable on psychotropic medication for 4 weeks before participating.
What safety data exists for intensive CBT for PTSD?The safety data for intensive CBT for PTSD, particularly intensive prolonged exposure (iPE), indicates that it is generally safe for patients with chronic PTSD. In a study involving 73 participants, none dropped out during the intensive phase, and only 5% during the booster phase. Adverse events were extremely low, with only a minority experiencing symptom exacerbation. This suggests that intensive CBT can be a safe treatment option for PTSD, even in patients with a history of multiple traumas and previous treatment attempts.24678
What data supports the idea that Intensive CBT for PTSD is an effective treatment?The available research shows that Intensive CBT for PTSD is effective. One study found that clients with severe mental illness and PTSD who received CBT improved significantly more than those who received standard care. They had fewer PTSD symptoms and better perceived health. Another study on veterans showed that an intensive outpatient program had a high completion rate and effectively reduced PTSD symptoms. These findings suggest that Intensive CBT can be a promising treatment option for PTSD.145910
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.Treatment Details
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.
3Treatment groups
Experimental Treatment
Active Control
Group I: iTCBT-I (Intensive Transdiagnostic Cognitive Behavioral Therapy-Individual)Experimental Treatment1 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 Control1 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 Control1 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
Find a clinic near you
Research locations nearbySelect from list below to view details:
Michael E. DeBakey VA Medical CenterHouston, TX
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Who is running the clinical trial?
Baylor College of MedicineLead Sponsor
United States Department of DefenseCollaborator
References
A randomized controlled trial of cognitive-behavioral treatment for posttraumatic stress disorder in severe mental illness. [2022]A cognitive-behavioral therapy (CBT) program for posttraumatic stress disorder (PTSD) was developed to address its high prevalence in persons with severe mental illness receiving treatment at community mental health centers. CBT was compared with treatment as usual (TAU) in a randomized controlled trial with 108 clients with PTSD and either major mood disorder (85%) or schizophrenia or schizoaffective disorder (15%), of whom 25% also had borderline personality disorder. Eighty-one percent of clients assigned to CBT participated in the program. Intent-to-treat analyses showed that CBT clients improved significantly more than did clients in TAU at blinded posttreatment and 3- and 6-month follow-up assessments in PTSD symptoms, other symptoms, perceived health, negative trauma-related beliefs, knowledge about PTSD, and case manager working alliance. The effects of CBT on PTSD were strongest in clients with severe PTSD. Homework completion in CBT predicted greater reductions in symptoms. Changes in trauma-related beliefs in CBT mediated improvements in PTSD. The findings suggest that clients with severe mental illness and PTSD can benefit from CBT, despite severe symptoms, suicidal thinking, psychosis, and vulnerability to hospitalizations.
Asylum-seekers' experiences of trauma-focused cognitive behaviour therapy for post-traumatic stress disorder: a qualitative study. [2018]Trauma-focused CBT (TFCBT) is an evidence-based treatment for posttraumatic stress disorder (PTSD), but little is known about whether it is an acceptable and effective treatment for asylum-seekers presenting with PTSD.
Trauma-focused cognitive-behavioral therapy for children and adolescents: assessing the evidence. [2022]Trauma-Focused Cognitive-Behavioral Therapy (TF-CBT) is a conjoint parent-child treatment developed by Cohen, Mannarino, and Deblinger that uses cognitive-behavioral principles and exposure techniques to prevent and treat posttraumatic stress, depression, and behavioral problems. This review defined TF-CBT, differentiated it from other models, and assessed the evidence base.
Clients' Experiences of Returning to the Trauma Site during PTSD Treatment: An Exploratory Study. [2018]Visits to the location of the trauma are often included in trauma-focused cognitive behavioural therapy (TF-CBT) for post-traumatic stress disorder (PTSD), but no research to date has explored how service users experience these visits, or whether and how they form an effective part of treatment.
Intensive cognitive therapy for post-traumatic stress disorder in routine clinical practice: A matched comparison audit. [2018]Intensive cognitive therapy for post-traumatic stress disorder (PTSD) has been shown to be as effective as weekly treatment in controlled trials. In this study, outcome data comparing standard and intensive treatments delivered in routine clinical practice were analysed.
Intensive prolonged exposure therapy for chronic PTSD patients following multiple trauma and multiple treatment attempts. [2020]Background: Suboptimal response and high dropout rates leave room for improvement of trauma-focused treatment (TFT) effectiveness in ameliorating posttraumatic stress disorder (PTSD) symptoms. Objective: To explore the effectiveness and safety of intensive prolonged exposure (iPE) targeting chronic PTSD patients with a likely diagnosis of ICD-11 Complex PTSD following multiple interpersonal trauma and a history of multiple treatment attempts. Method: Participants (N = 73) received iPE in 12 × 90-minute sessions over four days (intensive phase) followed by four weekly 90-minute booster prolonged exposure (PE) sessions (booster phase). The primary outcomes, clinician-rated severity of PTSD symptoms, and diagnostic status (Clinician-Administered PTSD Scale; CAPS-IV) were assessed at baseline, post-treatment, and at three and six months. Treatment response trajectories were identified and predictors of these trajectories explored. Results: Mixed model repeated measures analysis of CAPS-IV scores showed a baseline-to-posttreatment decrease in PTSD symptom severity (p < .001) that persisted during the three- and six-month follow-ups with large effect sizes (Cohen's d > 1.2); 71% of the participants responded. None of the participants dropped out during the intensive phase and only 5% during the booster phase. Adverse events were extremely low and only a minority showed symptom exacerbation. Cluster analysis demonstrated four treatment response trajectories: Fast responders (13%), Slow responders (26%), Partial responders (32%), and Non-responders (29%). Living condition and between-session fear habituation were found to predict outcome. Participants living alone were more likely to belong to the Partial responders than to the Non-responders cluster, and participants showing more between-session fear habituation were more likely to belong to the Fast responders than to the Non-responders cluster. Conclusions: The results of this open study suggest that iPE can be effective in PTSD patients with multiple interpersonal trauma and after multiple previous treatment attempts. In addition, in this chronic PTSD population iPE was safe.
Acceptability of a Plasticity-Focused Serious Game Intervention for Posttraumatic Stress Disorder: User Requirements Analysis. [2020]Trauma-focused cognitive behavioral therapy (TF-CBT) is a first-line treatment for posttraumatic stress disorder (PTSD). Despite a solid evidence base, TF-CBT response and attrition rates vary considerably. Plasticity-focused interventions, including the use of serious games, have the potential to improve TF-CBT response and treatment retention.
An intensive form of trauma focused cognitive behaviour therapy in an acute adolescent inpatient unit: An uncontrolled open trial. [2022]Post-traumatic stress disorder (PTSD) rates among hospitalised adolescents are between 21% and 32%, and there is a lack of evidence-based interventions for this population. Trauma-focused cognitive behaviour therapy (TF-CBT) is an evidence-based intervention for children and adolescents with PTSD; however, it has not been implemented in an acute adolescent inpatient unit. This study examines the implementation of an intensive form of TF-CBT in an adolescent inpatient unit.
Maintenance of treatment gains up to 12-months following a three-week cognitive processing therapy-based intensive PTSD treatment programme for veterans. [2022]Intensive treatment programmes (ITPs) have shown promise for reducing PTSD and depression symptoms. It is still unknown whether treatment gains are maintained following completion.
Feasibility of an intensive outpatient treatment program for posttraumatic stress disorder within the veterans health care administration. [2023]Trauma-focused treatments for posttraumatic stress disorder (PTSD), such as Prolonged Exposure (PE) therapy and Cognitive Processing Therapy (CPT), are effective and supported by various Clinical Practice Guidelines; however, drop-out rates for the treatments are as high as 40% within clinical programs. One promising solution is delivering the evidence-based psychotherapies (EBPs) three or more times per week within an intensive outpatient program (IOP) for PTSD. The present study examined the feasibility and effectiveness of a relatively low-resourced PTSD IOP within a larger PTSD program at the Veterans Healthcare Administration. The intensive program offers two tracks (2 week or 4 week) grounded in the massed delivery of PE and CPT. Over a 12-month period, 351 veterans completed an assessment for PTSD and 172 started within one of the local PTSD programs (e.g., weekly, IOP, or residential). Results of the study demonstrated that the IOP is an acceptable (i.e., 87.3% completion rate) and effective (e.g., PTSD Checklist for Diagnostic and Statistical Manual [DSM-5] [PCL-5] decrease effect size d = 1.80) treatment option. There was also adequate demand for the program (e.g., 37.2% of patients engaged in care with the PTSD programs started the IOP), and the program was implemented with fidelity to the design. Taken together, the results of this study demonstrate that this low-resource IOP model is a promising approach to improve completion rates within the continuum of care for the treatment of PTSD. (PsycInfo Database Record (c) 2023 APA, all rights reserved).