60 Participants Needed

Cognitive Processing Therapy for PTSD During Pregnancy

RA
Overseen ByResearch Associate I
Age: 18 - 65
Sex: Female
Trial Phase: Academic
Sponsor: University of Texas at Austin
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial targets pregnant women with PTSD (posttraumatic stress disorder) and compares two therapy types. One group will attend regular weekly sessions of Cognitive Processing Therapy (CPT), while the other will participate in more frequent sessions over a short period (massed CPT). The trial aims to determine which therapy better alleviates PTSD and depression, affects bonding with the baby, and impacts pregnancy and newborn health outcomes. Pregnant women with PTSD, particularly those with past trauma experiences, may find this trial suitable. As an unphased trial, it offers a unique opportunity to explore effective therapy options for PTSD during pregnancy, potentially improving both maternal and newborn health.

Will I have to stop taking my current medications?

You can continue taking your current medications, but they must be stable with no changes for at least 2 weeks (6 weeks for fluoxetine) before starting the trial, and you cannot change them during the therapy.

What prior data suggests that these therapy protocols are safe for pregnant women with PTSD?

Studies have shown that Cognitive Processing Therapy (CPT) is generally safe for treating PTSD in pregnant women. Research indicates no major negative effects have been reported in studies involving CPT, suggesting the therapy is well-tolerated. Less specific safety data exists for the more intensive version, Massed Cognitive Processing Therapy (mCPT). However, since both CPT and mCPT are types of talk therapy rather than medication, they likely share a similar safety profile. Talk therapies like these avoid the side effects often associated with drugs, making them a safer option during pregnancy.12345

Why are researchers excited about this trial?

Researchers are excited about using Cognitive Processing Therapy (CPT) for PTSD during pregnancy because it offers a structured, therapeutic approach without relying on medication, which is a big plus for expectant mothers. Traditional treatments often involve medications like SSRIs, which may not be ideal during pregnancy. What makes CPT unique is its focus on changing harmful thought patterns through talk therapy. The study also explores Massed Cognitive Processing Therapy (mCPT), which condenses treatment into just five days with multiple sessions each day. This accelerated approach could be especially beneficial, offering quicker relief from PTSD symptoms compared to the standard weekly sessions over three months.

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

This trial will compare two approaches to Cognitive Processing Therapy (CPT) for pregnant women with PTSD. Studies have shown that CPT helps reduce PTSD symptoms, with one study finding a significant drop in PCL scores of over 20 points, indicating strong improvement. Research also shows that these benefits last for months after treatment. In this trial, participants may receive Regular CPT, involving one 60-minute session per week for 12 weeks, or Massed CPT (mCPT), which consists of two 60-minute sessions each day for 5 consecutive days. Early findings suggest that mCPT can be just as effective as regular CPT but in a shorter time, offering flexibility in treatment duration.25678

Who Is on the Research Team?

ER

Erin Richardson

Principal Investigator

University of Texas at Austin

Are You a Good Fit for This Trial?

This trial is for pregnant women diagnosed with PTSD, showing significant symptoms (PCL-5 score > 33). It's not clear what the exclusion criteria are, but typically participants would be excluded if they have conditions or circumstances that could interfere with the treatment or skew results.

Inclusion Criteria

History of at least 1 criterion A trauma
I am a woman aged 18-46, pregnant (less than 25 weeks), and can read and write in English.
My PTSD diagnosis has been confirmed by a clinical interview.
See 1 more

Exclusion Criteria

Not currently pregnant
Suicidal ideation with plan or intent
Substance use disorder
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either conventional CPT (12 weekly sessions) or massed CPT (12 sessions over 5 days) via telemedicine for PTSD treatment

12 weeks
12 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
4 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • Cognitive Processing Therapy (CPT)
  • Massed Cognitive Processing Therapy (mCPT)
Trial Overview The study compares two ways of delivering Cognitive Processing Therapy (CPT) to treat PTSD in pregnant women: regular CPT once a week for 12 weeks and massed CPT over five days. The goal is to see which method works better for reducing PTSD and depression symptoms and improving mother-infant relationships.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: mCPTExperimental Treatment1 Intervention
Group II: Regular CPTExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Texas at Austin

Lead Sponsor

Trials
387
Recruited
86,100+

Citations

Effectiveness of Cognitive Processing Therapy in Pregnant ...This study will assess the effectiveness of cognitive processing therapy (CPT) or cognitive behavioral therapy (CBT) among women who are experiencing symptoms ...
Cognitive Processing Therapy for Childbirth-Related ...Following CPT for CB-PTSD, clinically significant and meaningful treatment outcomes were produced in both PTSD and depressive symptoms, with gains maintained at ...
Effectiveness of Trauma-Focused Psychological Therapies for ...Results suggest that TFPT are effective for reducing PTSD symptoms in the short term (up to 3 months postpartum [4 RCTs, n = 301, SMD = −0.50, 95% CI = −0.73 to ...
Cognitive Processing Therapy for Posttraumatic Stress ...In this randomized clinical trial of CPT-TAU vs WL-TAU, CPT was superior in reducing PTSD symptoms. These results strengthen the evidence for use of CPT in ...
Engagement in and Benefits of a Short-Term, Brief ...The intervention was successful at significantly decreasing symptoms of PTSD (PCL score = −20.27, 95% CI: −25.62, −14.92, P < 0.001, W = −7.43) ...
Cognitive Processing Therapy (CPT) for Perinatal ...The research aims will be three-fold: (1) Evaluate the relative efficacy and tolerability of CPT vs. mCPT for treatment of perinatal PTSD and depression.
A Case Study Applying Cognitive Processing Therapy to ...4–19% of those who give birth develop childbirth-related PTSD. •. Parental PTSD is associated with adverse health outcomes for both parent and child.
The effects of PTSD treatment during pregnancyDespite the fact that case studies as the one presented here report no adverse events, and treatment is likely safe, due to the poor ...
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