- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03641924
Cognition and Psychotherapy in PTSD
Cognition and Psychotherapy in PTSD: Mechanisms and Functional Outcomes
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Accumulating evidence indicates that memory dysfunction: 1) is prominent in PTSD; and 2) adversely affects psychotherapy outcomes. Identifying mechanisms underlying the relationship between memory dysfunction and poor treatment outcomes is crucial to provide empirical guidance regarding appropriate rehabilitation targets to reduce the impact of cognitive dysfunction on therapy outcomes.
In this study, the investigators aim to examine the specific effects of verbal memory on both PTSD symptoms and functional outcomes during CPT (Aim 1); identify the pathways by which cognitive dysfunction affects psychotherapy treatment response, with a focus on memory for treatment content and treatment adherence (Aim 2).
To achieve these aims, the investigators will enroll 105 Veterans with PTSD, who will complete a standard course of cognitive processing therapy (CPT) and complete longitudinal assessments of PTSD symptoms, functional status, treatment adherence, and memory for treatment content. This study does not randomize participants to treatment since all participants will be initiating CPT.
Recruitment. Participants will primarily be drawn from clinical referrals for PTSD therapy at the Corporal Michael J. Crescenz VA Medical Center (CMC VAMC) or its Community Based Outpatient Clinics (CBOCs).
Procedures. Participants will provide written informed consent and undergo intake screening. Major assessments will be conducted with participants at study entry (baseline), after session 6, and after session 12 (critical endpoint assessment) of CPT.
Baseline Visit (180-240 mins). Baseline procedures (before starting CPT) include diagnostic interviews, questionnaires assessing mood and functioning, a neurocognitive assessment, and additional memory measures. Participants will complete structured interview assessments for psychiatric conditions including PTSD, stressful life events, sociodemographics and medical history, and traumatic brain injury. Self-report assessments of mood, functional status (e.g., social adjustment), combat exposure, and behavioral functioning will also be administered. The neurocognitive assessment will include conventional neuropsychological tests and tests drawn from the Penn Computerized Neurocognitive Battery to assess multiple cognitive domains including memory, attention, speed of information processing, executive functioning, social cognition, and an IQ estimate. Additional experimental measures of memory processes from cognitive science will also be administered.
Psychotherapy. After the baseline visit, participants will begin a standard course of CPT (12 sessions) following standardized protocols (Resick et al, 2008) with the investigators' study therapists, who will all have extensive, formalized training in CPT and be supervised by an expert in CPT. Therapists will be blinded to scores on cognitive measures. After the initial CPT session, participants will complete questionnaires of treatment expectancy and self-efficacy (10 mins). At every following CPT visit, patients will complete brief questionnaires of adherence and application of treatment, depression symptoms, and suicide risk.
Mid-Treatment Assessments (20-30 mins). At CPT sessions 4, 6, 8, and 12 (end), participants will complete measures of memory for treatment content, treatment expectancy, and brief re-assessments of PTSD, mood, and functioning.
End of Treatment Assessment (120-180 mins). At the end of treatment, a final visit will consist of questionnaires and interviews to assess symptoms of PTSD, mood, functioning, cognitive functioning and memory for treatment content.
Although not a clinical trial, the investigators will examine individual change in symptoms at treatment end. Participants who drop out and are not able to be re-engaged will be contacted by study staff and asked to participate in a final assessment. After this visit is complete (or if the participant refuses), Veterans will be offered additional treatment at CMC VAMC as appropriate, with a warm handoff from study staff to the clinical team. Treatment non-responders, defined as participants displaying less than a 10-point reduction in CAPS Scores at follow-up, will also be referred for further treatment.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104-4551
- Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- DSM-5 criteria for PTSD via the Clinician Administered PTSD Scale (CAPS-5)
- Willing to initiate CPT
Exclusion Criteria:
- Substance use disorder (moderate or above) not in remission for >1 mo
- Severe psychiatric illness (e.g., psychosis)
- Significant current suicidal or homicidal intent, including a specific plan
- Dementia, neurological disorder, or severe TBI (i.e., loss of consciousness > 24h)
- Inability to speak or read English
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
PTSD
Veterans diagnosed with DSM-V PTSD
|
Cognitive Processing Therapy is an evidence-based psychotherapy for PTSD.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in PTSD Checklist (PCL-5)
Time Frame: Baseline to 12 weeks
|
PTSD Symptoms.
The range of the scale is from 0 (no symptoms) to 80 (maximal symptoms).
|
Baseline to 12 weeks
|
Social Adjustment Scale-Self Report (SAS-SR)
Time Frame: Baseline to 12 weeks
|
Functional Status.
Scored 1-5, with higher scores indicating worse functioning.
|
Baseline to 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Veterans RAND 12 Item Health Survey (VR-12)
Time Frame: Baseline to 12 weeks
|
Health-Related Quality of Life.
Scores range from 0-100; higher values indicate better physical or mental health-related quality of life.
|
Baseline to 12 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: James C. Scott, PhD, Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- D2699-R
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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