Cognitive Processing Therapy + CBT-t for Post-Traumatic Stress Disorder

Overseen By Amanda Flores, BA

Age: 18+

Sex: Any

Trial Phase: Academic

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

Disqualifiers: Severe hearing loss, Suicidal ideation, Substance use, others

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

Compensation: Varies

Number of Visits: 1

Duration: 6 months

160 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the best way to assist individuals with both PTSD (post-traumatic stress disorder) and tinnitus (ringing in the ears). Participants will undergo therapy in two sequences: Cognitive Processing Therapy for PTSD followed by CBT-t for tinnitus, or vice versa. Researchers aim to determine which order is more effective and how therapy alters brain function. The trial targets active military personnel and veterans with PTSD, bothersome tinnitus possibly linked to a past concussion, and who are stable on any prescribed medications. As an unphased trial, this study provides a unique opportunity to enhance understanding of effective therapy sequences for PTSD and tinnitus.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but it mentions that participants should be stable on any psychotropic medications (medications for mental health conditions). It's best to discuss your specific medications with the trial coordinators.

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

Research has shown that Cognitive Processing Therapy (CPT) is generally safe and effective for treating PTSD. One study found that patients experienced a significant reduction in PTSD symptoms, with many no longer meeting the criteria for PTSD after treatment. This indicates CPT's effectiveness and lack of major safety concerns.

For Cognitive Behavioral Therapy for Tinnitus (CBT-t), studies have found it reduces the distress caused by tinnitus. After CBT-t, fewer patients report severe impacts from tinnitus. This demonstrates that CBT-t is both helpful and safe for most people.

Both treatments have strong evidence supporting their safety, allowing participants to feel confident about their well-being during the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for PTSD because they combine Cognitive Processing Therapy (CPT) with Cognitive Behavioral Therapy for tinnitus (CBT-t), addressing both PTSD and tinnitus symptoms. Unlike standard treatments, which often tackle these conditions separately, this approach aims to provide comprehensive care by integrating therapies. The unique sequencing of therapies—either starting with CPT or CBT-t—may offer insights into how tackling both conditions simultaneously can improve overall outcomes. This dual approach is innovative and could pave the way for more holistic treatment strategies for patients experiencing PTSD with concurrent tinnitus.

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

This trial will compare two treatment sequences for addressing PTSD and tinnitus. In one arm, participants will receive Cognitive Processing Therapy (CPT) for PTSD followed by Cognitive Behavioral Therapy for Tinnitus (CBT-t). In the other arm, participants will receive CBT-t followed by CPT. Studies have shown that CPT effectively treats PTSD by significantly reducing its symptoms, with one study showing a 14-point drop in PTSD symptom scores. Similarly, CBT-t reduces the impact of tinnitus, with patients reporting less distress and better management of tinnitus in their daily lives. Both therapies show promise for addressing PTSD and tinnitus when used sequentially. ^{3 6 7 8 9}

Who Is on the Research Team?

John Moring, PhD

Principal Investigator

The University of Texas Health Science Center at San Antonio

Are You a Good Fit for This Trial?

This trial is for adult military personnel and veterans who have both PTSD and bothersome tinnitus, can speak English, are stable on any psychotropic meds, and have had at least one mild traumatic brain injury. It's not for those with severe hearing loss or brain damage, current severe suicidal thoughts, recent psychiatric hospitalization, ongoing substance abuse issues that interfere with therapy, certain jaw disorders causing acute pain, or significant cognitive impairment.

Inclusion Criteria

My mental health medication doses have not changed recently.

I have long-term ringing in my ears that bothers me.

Ability to speak and read English

Exclusion Criteria

I do not have severe hearing loss that would stop me from benefiting from the therapy.

I have moderate to severe brain damage.

Current severe suicidal ideation

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 Cognitive Processing Therapy (CPT) for PTSD followed by Cognitive Behavioral Therapy for Tinnitus (CBT-t) or vice versa

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• CBT-t
• Cognitive Processing Therapy

Trial Overview Researchers are testing the effectiveness of two therapies: Cognitive Processing Therapy (CPT) for PTSD and Cognitive Behavioral Therapy for Tinnitus (CBT-t). They want to see which order of receiving these treatments works best. The study also looks at how these therapies affect brain function in participants.

How Is the Trial Designed?

Group I: CPT-CBTt Active Control 2 Interventions

Participants will receive Cognitive Processing Therapy for PTSD followed by Cognitive Behavioral Therapy for Tinnitus

Group II: CBTt-CPT Active Control 2 Interventions

Participants will receive Cognitive Behavioral Therapy for Tinnitus followed by Cognitive Processing Therapy for PTSD

Who Is Running the Clinical Trial?

The University of Texas Health Science Center at San Antonio

Lead Sponsor

Trials

486

Recruited

92,500+

University of Illinois at Urbana-Champaign

Collaborator

Trials

203

Recruited

40,600+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10558150/

Acceptability of Cognitive Behavioral Therapy for Tinnitus Despite strong research support, CBT was rated as less acceptable than a different, less widely empirically supported treatment.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05981391

Neurobiological Similarities of Tinnitus and PTSD Understanding the shared cognitive, emotional, and behavioral symptoms and neurobiology associated with tinnitus and PTSD will help clinicians and researchers ...

3. pubs.asha.org pubs.asha.org/doi/abs/10.1044/2023_AJA-23-00020

Acceptability of Cognitive Behavioral Therapy for Tinnitus Veteran ratings of credibility, expectancy, and acceptability were significantly lower than nonveteran ratings across treatments. There were differences in ...

4. adaa.org adaa.org/learn-from-us/from-the-experts/blog-posts/consumer/cognitive-behavioral-therapy-tinnitus

Cognitive Behavioral Therapy for Tinnitus: Reduce Distress ... When done correctly, CBT for tinnitus is an effective, efficient method for getting out of our ears and back into our lives! Dr. Hubbard's ...

5. mdpi.com mdpi.com/2076-3425/15/5/526

Cognitive Behavioural Therapy (CBT) for Managing ... They concluded that a significant reduction (improvement) in tinnitus impact and depression was achieved by patients who received CBT compared to the control ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02438891

Treatment of Tinnitus Using a Web-based Sound and ... The purpose of this study is to evaluate a internet-based cognitive behavioral therapy (CBT) system as a method of treating patients with tinnitus. Tinnitus is ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12109689/

Cognitive Behavioural Therapy (CBT) for Managing ... Following CBT, these numbers dropped substantially: 37.5% of patients still experienced tinnitus impact according to the TIQ (25% severe impact, 12.5% slight ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6956618/

Cognitive behavioural therapy for tinnitus - PMC We found 28 relevant studies, mostly from Europe, with a total of 2733 participants. The participants receiving CBT had treatment for between three and 22 weeks ...

9. clinicaltrial.be clinicaltrial.be/en/details/556881?per_page=100&recruiting=1&enrolling_by_invitation=0&active_not_recruiting=0&not_yet_recruiting=0&completed=0&only_recruiting=1&only_eligible=0

Treatment for PTSD and Tinnitus CBT-t includes using behavioral principles to help manage tinnitus reactions, including the use of sounds: soothing sounds, background sound, ...