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

304 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Cognitive behavioral therapy (CBT) is a brief, efficient, and effective treatment for individuals with depressive/anxiety disorders. However, CBT is largely underutilized within the Department of Veterans Affairs due to the cost and burden of trainings necessary to deliver all of the related disorder-specific treatments (DSTs). Transdiagnostic Behavior Therapy (TBT), in contrast, is specifically designed to address numerous distinct disorders within a single protocol in Veterans with depressive/anxiety disorders, including posttraumatic stress disorder. The proposed research seeks to evaluate the efficacy of TBT by assessing psychiatric symptomatology and related impairment outcomes in Veterans with depressive/anxiety disorders via a randomized controlled trial of TBT and existing DSTs in Veterans with major depressive disorder, posttraumatic stress disorder, and panic disorder. Assessments will be completed at pre-, mid-, and post-treatment, and at 6-month follow-up. Process variables also will be investigated.

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+