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Cognitive Processing Therapy + Memory Support for PTSD

N/A

Recruiting

Led By Joseph Carpenter, PhD MA

Research Sponsored by Boston University

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare the effects of cognitive processing therapy with and without a memory support intervention to see if the memory support intervention leads to greater memory and learning of therapy content.

Who is the study for?

Adults with PTSD can join this study. They must have a stable dose of psychiatric meds for the last month if they're taking any, and veterans are specifically welcomed. People with unstable bipolar disorder, psychosis, severe substance abuse, or past severe brain injury cannot participate. Also excluded are those with high verbal memory skills or significant cognitive impairment.

What is being tested?

The trial is testing whether adding Memory Support (MS) to Cognitive Processing Therapy (CPT) helps people remember therapy content better than CPT alone. It's a small-scale test involving 52 adults to see if it's feasible and acceptable to combine these treatments for PTSD.

What are the potential side effects?

Since this trial involves psychological interventions rather than medications, traditional side effects like you might get from drugs aren't expected here. However, participants may experience emotional discomfort as they engage in therapy related to their trauma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 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

Feasibility assessed by mean CPT Adherence

Feasibility assessed by mean CPT Competence

Feasibility assessed by the Memory Support Rating Scale (MSRS)

+8 more

Secondary study objectives

Follow-up Change in Depression symptoms assessed by the Patient Health Questionnaire 9-item (PHQ-9)

Follow-up Change in Memory of Therapy Content assessed by the Generalization Task

Follow-up Change in PTSD symptoms assessed by the Clinician Administered PTSD Scale for DSM-5 (CAPS-5)

+16 more

Other study objectives

Follow-up Change in PTSD-related cognitions assessed by the Posttraumatic Cognitions Inventory - 9-item (PTCI-9)

Follow-up Change in PTSD-related coping self-efficacy assessed by the Trauma Coping Self Efficacy Scale (CSE-T)

Follow-up Change in cognitive complaints assessed by the Cognitive Self-Report Questionnaire - Cognitive subscale (CSRQ-C)

+5 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 + Memory Support (CPT + MS)Experimental Treatment2 Interventions

CPT + MS will involve the same treatment strategies as CPT while incorporating deliberate and frequent use of memory and learning support strategies. MS strategies are designed to enhance the memory of specific treatment points, defined as any insight, skill or strategy determined to be important for the patient to remember and/or implement. MS is not designed to enhance memory functioning generally, but rather improve the encoding, consolidation and retrieval of specific components of therapeutic learning.

Group II: Cognitive Processing Therapy (CPT)Active Control1 Intervention

CPT is a manualized, trauma-focused therapy for PTSD. Treatment consists of psychoeducation on the cognitive model of PTSD, identification of trauma-related stuck points (i.e. dysfunctional beliefs), and cognitive challenging techniques to help participants identify more realistic and adaptive ways of viewing their trauma, themselves, and the world.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

2020

N/A

~20

CPT

2012

N/A

~180

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