What is the mechanism of action of this treatment?

Cognitive Processing Therapy (CPT) and other cognitive-behavioral therapies (CBT) are common treatments for PTSD that work by helping patients process and reframe traumatic events. These therapies focus on identifying and challenging maladaptive thoughts and beliefs related to the trauma, which can lead to a reduction in PTSD symptoms such as anxiety, depression, and hypervigilance. By reframing these thoughts, patients can develop healthier coping mechanisms and reduce risky behaviors, such as substance abuse or unsafe sexual practices. This is crucial for PTSD patients as it not only alleviates their symptoms but also improves their overall quality of life and reduces the likelihood of further trauma or negative outcomes.

What side effects are associated with this type of intervention?

Common treatments for Post-Traumatic Stress Disorder (PTSD) include Cognitive Processing Therapy (CPT), other forms of cognitive-behavioral therapy (CBT), and pharmacotherapy such as selective serotonin reuptake inhibitors (SSRIs). CPT and other CBT approaches generally have minimal physical side effects but can cause emotional discomfort as patients confront and process traumatic memories. Pharmacotherapy, particularly SSRIs like sertraline, can cause side effects such as nausea, insomnia, sexual dysfunction, and increased anxiety initially. It is important for patients to discuss these potential side effects with their healthcare provider to tailor the treatment plan to their individual needs.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of PTSD, primarily focusing on selective serotonin reuptake inhibitors (SSRIs) such as sertraline and paroxetine. These medications help alleviate PTSD symptoms by regulating serotonin levels in the brain. Additionally, prazosin, an alpha-adrenergic receptor blocker, is often used off-label to manage PTSD-related nightmares and sleep disturbances. Cognitive-behavioral therapies, including Cognitive Processing Therapy (CPT) and Prolonged Exposure (PE), are also widely recognized and recommended for their effectiveness in helping patients process and reframe traumatic events, thereby reducing PTSD symptoms and associated risky behaviors.

What other types of research exist?

Promising, novel alternatives to Cognitive Processing Therapy (CPT) for PTSD patients include: 1) Prolonged Exposure Therapy (PE), which involves repeated, detailed imagining of the trauma or progressive exposure to trauma reminders to reduce PTSD symptoms. 2) Dialectical Behavior Therapy (DBT), which emphasizes managing suicidal and other dangerous behaviors, treatment-interfering behaviors, and quality of life-interfering behaviors. 3) Mentalization-Based Therapy (MBT), which helps patients observe their state of mind and generate alternative perspectives of their experiences. 4) Transference-Focused Therapy (TFT), which involves exploration and interpretation of emotionally charged issues in the patient-therapist relationship. 5) Schema-Focused Therapy, which combines individual and group therapy to address maladaptive schemas and improve emotional regulation.

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Behavioral Intervention

Cognitive Processing Therapy for PTSD in Individuals with HIV

N/A

Waitlist Available

Led By Cristina Lopez, PhD

Research Sponsored by Medical University of South Carolina

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Individuals that are 18 years and older

Be older than 18 years old

Must not have

Evidence of psychotic symptoms (e.g., active hallucinations, delusions, impaired thought processes)

Evidence of developmental delays, or pervasive developmental disorder, or active suicidal or homicidal ideations

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 18 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test a talk therapy called Cognitive Processing Therapy (CPT) for people with HIV who also have PTSD. The therapy helps them change negative thoughts about their trauma, which may improve their ability to stick to HIV treatment. Cognitive Processing Therapy (CPT) is effective in treating PTSD, but there remains a need to improve outcomes for individuals who do not fully respond to treatment.

Who is the study for?

This trial is for adults over 18 with HIV and PTSD who are linked to a Ryan White clinic in South Carolina. They must have had changes in their HIV treatment, missed appointments, or shown less than perfect adherence to antiretroviral therapy recently. Participants need an adequate score on a cognitive assessment and meet specific criteria for PTSD but can't join if they have severe mental health issues like psychosis or developmental disorders.

What is being tested?

The study is testing Cognitive Processing Therapy adapted for individuals with HIV (CPT-L) against the standard Lifesteps program to see if it helps improve outcomes for those suffering from both PTSD and HIV by reducing risky behaviors that could transmit HIV.

What are the potential side effects?

Since this trial involves psychological therapy rather than medication, side effects may include emotional discomfort during sessions as participants work through traumatic experiences related to their PTSD.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I experience symptoms like hallucinations or delusions.

Select...

I have developmental delays or have been diagnosed with a pervasive developmental disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Average number of enrolled participants per month

Percent of completed participants

Percent of eligible participants

Secondary study objectives

Mean score of PTSD symptoms

Mean score of WHOQOL-HIV BREF (World Health Organization Quality of Life- HIV )

Mean score of WHOQOL-HIV BREF (World Health Organization Quality of Life- HIV)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Cognitive Processing Therapy-Lifesteps (CPT-L) [Group A]Experimental Treatment2 Interventions

Group II: Lifesteps [Group B]Active Control1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cognitive Processing Therapy- Lifesteps (CPT-L)

2022

N/A

~50

Lifesteps

2022

N/A

~50

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Cognitive Processing Therapy (CPT) and other cognitive-behavioral therapies (CBT) are common treatments for PTSD that work by helping patients process and reframe traumatic events. These therapies focus on identifying and challenging maladaptive thoughts and beliefs related to the trauma, which can lead to a reduction in PTSD symptoms such as anxiety, depression, and hypervigilance. By reframing these thoughts, patients can develop healthier coping mechanisms and reduce risky behaviors, such as substance abuse or unsafe sexual practices. This is crucial for PTSD patients as it not only alleviates their symptoms but also improves their overall quality of life and reduces the likelihood of further trauma or negative outcomes.