Enhancing Memory in CPT for PTSD
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ClinicalTrials.gov Identifier: NCT06000475 |
Recruitment Status :
Not yet recruiting
First Posted : August 21, 2023
Last Update Posted : February 23, 2024
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Condition or disease | Intervention/treatment | Phase |
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Stress Disorders, Post-Traumatic | Behavioral: Cognitive Processing Therapy Behavioral: Cognitive Processing Therapy (CPT) + Memory Support | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 30 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Masking Description: | Blinded to treatment status during feasibility trial |
Primary Purpose: | Treatment |
Official Title: | Enhancing Memory in Cognitive Processing Therapy for Older Adults With PTSD |
Estimated Study Start Date : | July 1, 2024 |
Estimated Primary Completion Date : | September 30, 2025 |
Estimated Study Completion Date : | September 30, 2025 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Cognitive Processing Therapy (CPT)
Standard CPT as described in the treatment manual
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Behavioral: Cognitive Processing Therapy
CPT as described in the treatment manual
Other Name: CPT |
Experimental: Cognitive Processing Therapy (CPT) + Memory Support
CPT+Memory support will also incorporate frequent and intentional use of strategies to enhance learning and memory of this content.
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Behavioral: Cognitive Processing Therapy
CPT as described in the treatment manual
Other Name: CPT Behavioral: Cognitive Processing Therapy (CPT) + Memory Support CPT+Memory support will also incorporate frequent and intentional use of strategies to enhance learning and memory of this content. |
- PTSD Checklist-5 (PCL-5) [ Time Frame: Through study completion, weeks 12-16 of treatment ]Questionnaire for symptoms of PTSD; the range of the scale is from 0 (no symptoms) to 80 (maximal symptoms).
- Client Satisfaction Questionnaire (CSQ) [ Time Frame: Through study completion, weeks 12-16 of treatment ]8-item patient satisfaction scale; the range of the scale is from 8 to 32, where low scores are indicative of low satisfaction and high scores are indicative of high satisfaction.
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Ages Eligible for Study: | 60 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Veterans with DSM-5 diagnoses of PTSD via the Clinician Administered PTSD Scale (CAPS-5)
- Age >59
Exclusion Criteria:
- daily benzodiazepine use (due to memory impairing effects)
- bipolar or psychotic disorders
- current suicidal ideation with plan or intent
- current moderate or severe substance use disorder not in remission for >1 mo.
- severe traumatic brain injury
- a Montreal Cognitive Assessment (MoCA) indicative of dementia
- or other disorders that would severely limit study participation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06000475
Contact: James C Scott, PhD | (215) 823-5800 ext 7138 | James.Scott2de50a@va.gov | |
Contact: Richard A Moore | (215) 823-5800 ext 7916 | richard.moore7@va.gov |
United States, Pennsylvania | |
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA | |
Philadelphia, Pennsylvania, United States, 19104-4551 | |
Contact: Kyong-Mi Chang, MD 215-823-5893 Kyong-Mi.Chang@va.gov | |
Contact: Richard A Moore (215) 823-5800 ext 7916 richard.moore7@va.gov | |
Principal Investigator: James C. Scott, PhD |
Principal Investigator: | James C. Scott, PhD | Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA |
Responsible Party: | VA Office of Research and Development |
ClinicalTrials.gov Identifier: | NCT06000475 |
Other Study ID Numbers: |
D4627-P 1I21RX004627 ( U.S. NIH Grant/Contract ) |
First Posted: | August 21, 2023 Key Record Dates |
Last Update Posted: | February 23, 2024 |
Last Verified: | February 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Stress Disorders, Post-Traumatic Psychotherapy Memory |
Stress Disorders, Traumatic Stress Disorders, Post-Traumatic Trauma and Stressor Related Disorders Mental Disorders |