Transdiagnostic Behavior Therapy for Depression and PTSD

Overseen By Daniel F Gros, PhD MA BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Recent hospitalization, Severe illness, TBI, others

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

Compensation: Varies

Number of Visits: 19

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new therapy called Transdiagnostic Behavior Therapy (TBT) to assist Veterans with depression, PTSD, and anxiety disorders. TBT aims to address multiple mental health issues simultaneously, potentially making therapy more efficient and accessible. The trial compares TBT to existing treatments that target specific disorders, such as Cognitive Behavioral Therapy for Major Depressive Disorder (MDD), Cognitive Behavioral Therapy for Panic Disorder, and Cognitive Processing Therapy for PTSD. Veterans diagnosed with depression, PTSD, or panic disorder who can participate in therapy sessions may be suitable candidates. As an unphased trial, this study provides Veterans the chance to explore a potentially more efficient therapy option for multiple mental health issues.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop your current medications, but you cannot have started a new psychiatric medication within the last 4 weeks. It's best to discuss your specific situation with the trial coordinators.

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

Research shows that Transdiagnostic Behavior Therapy (TBT) is a safe treatment option. Various studies have found TBT effective in reducing symptoms of depression, anxiety, and PTSD. Participants reported satisfaction with their treatment and successfully completed their therapy. TBT appears to work as well as treatments designed for specific disorders.

Regarding safety, these studies did not find any major negative effects, indicating that TBT is well-tolerated. The therapy uses exposure techniques tailored to the type of avoidance a person experiences, helping manage multiple symptoms simultaneously. These findings support the idea that TBT is a safe and effective choice for individuals dealing with several mental health issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Transdiagnostic Behavior Therapy (TBT) because it offers a fresh approach to treating depression and PTSD by addressing avoidance behaviors that cut across various mental health disorders. Unlike traditional therapies that focus on a single diagnosis like Cognitive Behavioral Therapy (CBT) for depression or Cognitive Processing Therapy (CPT) for PTSD, TBT uses four types of exposure techniques tailored to the unique avoidance patterns of each patient. This personalized method could lead to more effective and comprehensive treatment outcomes, potentially benefiting individuals with multiple overlapping disorders.

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

Research has shown that Transdiagnostic Behavior Therapy (TBT), which participants in this trial may receive, effectively reduces symptoms in people with anxiety and depression. One study found that most participants experienced moderate to significant improvements in their symptoms. TBT works as well as traditional treatments that focus on specific disorders, especially for depression. In this trial, some participants will receive disorder-specific therapies, such as Cognitive Behavioral Therapy (CBT) for specific conditions. Another analysis showed that TBT was just as effective as disorder-specific CBT and even better for treating depression. Overall, TBT can address multiple conditions simultaneously, making it a promising option for those with more than one mental health issue. ^{3 4 5 6 7}

Who Is on the Research Team?

Daniel F Gros, PhD MA BS

Principal Investigator

Ralph H. Johnson VA Medical Center, Charleston, SC

Are You a Good Fit for This Trial?

This trial is for Veterans aged 18-80 with depression, PTSD, or panic disorder who can consent to research. It's not for those recently hospitalized for psychiatric reasons, have severe illnesses like active cancer treatment, or started new psychiatric meds in the last month.

Inclusion Criteria

I have been diagnosed with panic disorder, major depression, or PTSD.

I understand and can agree to the study's requirements.

Participants must be Veterans

Exclusion Criteria

I do not have a severe illness that would require hospitalization or interfere with the study.

I started a new psychiatric medication less than 4 weeks ago.

I have a moderate-to-severe traumatic brain injury.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive either Transdiagnostic Behavior Therapy or Disorder-Specific Therapies over 12 weekly sessions

12 weeks

12 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Assessments at 6-month follow-up

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Behavioral Therapy for MDD
• Cognitive Behavioral Therapy for Panic Disorder
• Cognitive Processing Therapy for PTSD
• Transdiagnostic Behavior Therapy

Trial Overview The study compares Transdiagnostic Behavior Therapy (TBT), a single protocol therapy designed to treat various disorders at once, with specific Cognitive Behavioral Therapies tailored individually for major depressive disorder (MDD), PTSD, and panic disorder.

How Is the Trial Designed?

Group I: Transdiagnostic Behavior Therapy Experimental Treatment 1 Intervention

TBT was developed to address transdiagnostic avoidance via the use of four different types of exposure techniques (situational/in-vivo, physical/interoceptive, thought/imaginal, and \[positive\] emotional/behavioral activation). From the transdiagnostic avoidance perspective, the four exposure practices are matched to the type(s) of avoidance experienced by patients based upon their cluster of symptoms/disorders.

Group II: Disorder Specific Therapies Active Control 3 Interventions

To provide an evidence-based comparison for the TBT condition, DSTs will be used that are matched to the participant's most severe diagnosis, based upon the average of the ADIS interference and distress scores. If the scores are equivalent for two or more diagnoses, participants will be asked to list which diagnosis/symptoms that they find most impairing. DSTs will be included for each of the three targeted diagnoses, including PTSD (CPT for PTSD), PD/AG (CBT for PD/AG), and MDD (CBT for MDD). Each of these DSTs have published manuals for administration and have received extensive support in the literature (Barlow, 2014).

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S000578942500111X

Behavior Therapy The present study compared Transdiagnostic Behavior Therapy (TBT) to disorder-specific therapies (DSTs) in 304 veterans with principal diagnoses ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10034571/

Efficacy of Transdiagnostic Behavior Therapy Across the ... Transdiagnostic behavior therapy (TBT) is one of the few transdiagnostic treatments shown to be effective for patients with anxiety disorders, major depressive ...

3. nature.com nature.com/articles/s41562-023-01787-3

A systematic review and meta-analysis of transdiagnostic ... TD-CBT showed comparable effects to disorder-specific CBT and was superior to other active treatments for depression but not for anxiety.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10530591/

Exploring trajectories in transdiagnostic behavior therapy The analyses revealed that the majority of participants who received TBT demonstrated symptom reductions with medium-to-large effect sizes ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0272735825001096

Together and beyond: A systematic review on ... 22 studies targeted anxiety and depression jointly with positive pre-post effects. Significant reductions in symptom severity were also reported for other ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8135031/

Initial Outcomes of Transdiagnostic Internet-Delivered ... Clients reported large symptom reductions on measures of depression and anxiety, as well as moderate reductions on measures of PTSD and secondary symptoms, ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0887618524000379

Outcomes of transdiagnostic internet-delivered cognitive ... Transdiagnostic online therapy was tailored to public safety personnel (PSP). PSP showed good treatment satisfaction, course completion, and symptom reduction.