Therapies for PTSD

(ADAPT-PTSD Trial)

Recruiting at 3 trial locations

Overseen By Stefanie LoSavio, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center at San Antonio

Disqualifiers: Acute suicide risk, Unmanaged psychosis, Bipolar, others

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

Compensation: Varies

Number of Visits: 10

Duration: 20 weeks

302 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different therapy strategies can better support veterans with PTSD, especially those not benefiting from their initial treatment or struggling with therapy homework. It examines whether switching to therapies like Cognitive Processing Therapy (CPT) or Prolonged Exposure (PE), or using modular versions of these therapies, can improve outcomes. Participants receive text message prompts to assist with homework between sessions. Veterans with PTSD who own a mobile device and are eligible for PE and CPT at a participating clinic might be suitable for this study. As an unphased trial, this study offers veterans the opportunity to explore innovative therapy strategies that could enhance their treatment experience.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

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

Research has shown that both Cognitive Processing Therapy (CPT) and Prolonged Exposure (PE) therapy have been thoroughly studied for treating post-traumatic stress disorder (PTSD). Studies indicate that CPT is generally well-tolerated, with only 14.7% of patients experiencing some side effects, which is low compared to other treatments. Most people notice improvements in PTSD and depression symptoms.

Prolonged Exposure therapy has also significantly reduced PTSD symptoms. Many studies demonstrate that PE is effective, with success rates between 65% and 80%. This means that most people find it helpful and safe.

Both therapies have been adapted into flexible forms, allowing for more personalized treatment plans. These adaptations have also improved PTSD symptoms without increasing side effects.

Since these therapies are well-researched and commonly used in clinical practice, they are considered safe with few side effects for most people. However, as with any treatment, individual experiences may vary. It's always important to consult a healthcare provider to ensure it's the right fit. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how different therapy approaches can be personalized for treating PTSD more effectively. Unlike traditional treatments that stick to a single method, this trial looks at how switching or modifying treatments, like transitioning from Cognitive Processing Therapy (CPT) to Prolonged Exposure (PE) therapy or using modular versions of these therapies, might benefit patients who don't initially respond. By adapting treatments based on early responses, the trial aims to find out if tailored therapy strategies lead to better outcomes and more flexibility in managing PTSD.

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

Research has shown that Cognitive Processing Therapy (CPT), one of the therapies studied in this trial, effectively treats PTSD by reducing symptoms and depression over time. Participants may receive either CPT or Prolonged Exposure (PE) therapy, another treatment option in this trial. Studies have found PE to be effective, with success rates between 65% and 80%. The trial also includes flexible versions of CPT and PE, tailored to individual needs, which lead to significant improvements in PTSD and depression. Additionally, Step Down Treatment, involving a transition to less intense therapy, is evaluated to help maintain progress and continue improvement after initial treatment. Each of these therapies has been tested in various settings and has shown positive results in reducing PTSD symptoms. ^{1 2 6 7 8}

Who Is on the Research Team?

Stefanie LoSavio, PhD

Principal Investigator

The University of Texas Health Science Center at San Antonio

Rebecca Sripada, PhD

Principal Investigator

VA Ann Arbor-506

Are You a Good Fit for This Trial?

This trial is for veterans struggling with Post-Traumatic Stress Disorder (PTSD) who haven't seen improvement from their initial treatment or have difficulty completing homework between therapy sessions. Specific eligibility details are not provided.

Inclusion Criteria

Score ≥ 31 on the PCL-5 secondary to a Criterion A traumatic event

Own a mobile device that can be used for the therapy companion mobile app (Prolonged Exposure (PE) coach or Cognitive Processing Therapy (CPT) coach)

I am a veteran over 18 eligible for PTSD treatment at a specific clinic.

Exclusion Criteria

Need for detoxification

Unmanaged psychosis or bipolar disorder

Current or past 12-month engagement in PE or CPT

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo multiple, sequential randomizations to both therapist-delivered and digital interventions to optimize PTSD treatment response

20 weeks

Regular visits as per treatment protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

9 months

Follow-up assessments at 10 weeks, 20 weeks, and 9 months

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Processing Therapy (CPT)
• Digital Interventions
• Modular Cognitive Processing Therapy
• Modular Prolonged Exposure Therapy
• Prolonged Exposure (PE)
• Step Down Treatment

Trial Overview The ADAPT-PTSD trial is testing various PTSD treatments, including Modular Cognitive Processing Therapy and Prolonged Exposure, both in traditional and digital formats. It also explores the effectiveness of text message prompts to enhance homework completion.

How Is the Trial Designed?

Group I: Early CPT Non-Responders Modular (Group B) Active Control 3 Interventions

Early NON-RESPONDERS to CPT will transition to MODULAR CPT

Group II: Early CPT Responders Continue (Group C) Active Control 2 Interventions

Early RESPONDERS to CPT will CONTINUE in their CPT treatment

Group III: Early PE Non-Responsers Switch (Group E) Active Control 3 Interventions

Early NON-RESPONDERS to PE will SWITCH to CPT

Group IV: Early PE Non-Responders Modular (Group F) Active Control 3 Interventions

Early NON-RESPONDERS to PE will transition to MODULAR PE

Group V: Early CPT Responders Step Down (Group D) Active Control 3 Interventions

Early RESPONDERS to CPT will STEP DOWN to self-managed CPT

Group VI: Early CPT Non-Responders Switch (Group A) Active Control 3 Interventions

Early NON-RESPONDERS to CPT will SWITCH to PE

Group VII: Early PE Responders Step Down (Group H) Active Control 3 Interventions

Early RESPONDERS to PE will STEP DOWN to self-managed PE

Group VIII: Early PE Responders Continue (Group G) Active Control 2 Interventions

Early RESPONDERS will CONTINUE in their PE treatment

Who Is Running the Clinical Trial?

The University of Texas Health Science Center at San Antonio

Lead Sponsor

Trials

486

Recruited

92,500+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30332919/

A meta-analytic review of cognitive processing therapy for ... These meta-analytic findings indicate that CPT is an effective PTSD treatment with lasting benefits across a range of outcomes.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2589979124000027

Effectiveness of Cognitive Processing Therapy for PTSD in ... This study provides promising data on the outcomes associated with a modified CPT protocol for treating PTSD in a high need but under-treated SMI population.

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2829857

Cognitive Processing Therapy for Posttraumatic Stress ... The CPT-TAU group maintained improvements in all outcomes from 17 to 34 weeks. Sensitivity analyses controlling for the types of traumatic ...

4. ptsd.va.gov ptsd.va.gov/professional/treat/txessentials/cpt_for_ptsd_pro.asp

Cognitive Processing Therapy for PTSD Participants in the active treatment conditions (both CPT and PE) demonstrated significant improvement in PTSD and depression over the course of treatment as ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3336190/

Long-Term Outcomes of Cognitive–Behavioral Treatments ... CPT and PE resulted in lasting changes in PTSD and related symptoms over an extended period of time for female rape victims with extensive histories of trauma.

6. sciencedirect.com sciencedirect.com/science/article/pii/S1077722922001377

Clinician Concerns About Cognitive Processing Therapy A secondary analysis of randomized clinical trial data showed that 14.7% of patients receiving CPT and 28.6% of clients receiving CPT with a written trauma ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11800015/

Cognitive Processing Therapy for Posttraumatic Stress ... Cognitive processing therapy (CPT) is an evidence-based treatment for posttraumatic stress disorder (PTSD). However, there is little evidence on ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT04230668

NCT04230668 | Cognitive Processing Therapy (CPT) for ... A pilot effectiveness trial of cognitive processing therapy augmented with suicide risk management for individuals with comorbid PTSD and BPD conditions.