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Cognition and Psychotherapy in PTSD

Cognition and Psychotherapy in PTSD: Mechanisms and Functional Outcomes

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03641924
Enrollment
110
Registered
2018-08-22
Start date
2019-05-20
Completion date
2023-09-29
Last updated
2025-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Posttraumatic Stress Disorder (PTSD)

Keywords

Posttraumatic Stress Disorder, Psychotherapy, Neuropsychology

Brief summary

Posttraumatic stress disorder (PTSD) is prevalent among combat Veterans and is a substantial public health burden. Several psychotherapies, including cognitive processing therapy (CPT) and prolonged exposure therapy, have been recommended as efficacious for the treatment of PTSD and are being disseminated nationally in the VA Healthcare System. Yet many individuals show limited benefit from such treatments. Accumulating evidence indicates that episodic memory deficits may be one factor limiting psychotherapy treatment efficacy in PTSD. The proposed study will determine whether verbal memory is a specific predictor of CPT outcomes in PTSD, including both symptom reductions and functional outcomes. The study will also determine the pathways by which memory functioning affects treatment outcomes by examining relationships between memory functioning, treatment engagement, recall of treatment content, and illness course. More specifically, analyses will examine whether memory for treatment content affects the relationship between memory functioning and treatment outcomes.

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.

Interventions

BEHAVIORALCognitive Processing Therapy

Cognitive Processing Therapy is an evidence-based psychotherapy for PTSD.

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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 traumatic brain injury (TBI; i.e., loss of consciousness \> 24h) * Inability to speak or read English

Design outcomes

Primary

MeasureTime frameDescription
Change in PTSD Checklist (PCL-5)Change from baseline to 12 weeksPTSD Symptoms. The range of the scale is from 0 (no symptoms) to 80 (maximal symptoms). Higher scores corresponds to more symptoms.
Social Adjustment Scale-Self Report (SAS-SR)Change from baseline to 12 weeksFunctional Status. Scored 1-5, with higher scores indicating worse functioning.

Secondary

MeasureTime frameDescription
Veterans RAND 12 Item Health Survey Mental Component Summary (VR-12 MCS)Change from baseline to 12 weeksMental Health-Related Quality of Life. Scores range from 0-100; higher values indicate better mental health-related quality of life.

Countries

United States

Participant flow

Pre-assignment details

28 participants either did not meet criteria for PTSD after a structured assessment (n=19), met criteria for a comorbid disorder that was exclusionary (n=4), or were lost to follow-up before completing baseline assessments.

Participants by arm

ArmCount
Veterans With PTSD
Veterans with DSM-5 PTSD as assessed with the Clinician Administered PTSD Scale
94
Total94

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyLost to Follow-up16
Overall StudyProtocol Violation10
Overall StudyWithdrawal by Subject26

Baseline characteristics

CharacteristicVeterans With PTSD
Age, Continuous45 years
STANDARD_DEVIATION 12
Mild Traumatic Brain Injury (TBI)49 Participants
Moderate TBI7 Participants
PTSD Checklist (PCL-5)45 units on a scale
STANDARD_DEVIATION 11
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants
Race (NIH/OMB)
Asian
4 Participants
Race (NIH/OMB)
Black or African American
40 Participants
Race (NIH/OMB)
More than one race
2 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
2 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
45 Participants
Region of Enrollment
United States
94 Participants
Sex: Female, Male
Female
30 Participants
Sex: Female, Male
Male
64 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 94
other
Total, other adverse events
0 / 94
serious
Total, serious adverse events
0 / 94

Outcome results

Primary

Change in PTSD Checklist (PCL-5)

PTSD Symptoms. The range of the scale is from 0 (no symptoms) to 80 (maximal symptoms). Higher scores corresponds to more symptoms.

Time frame: Change from baseline to 12 weeks

Population: Based on baseline memory scores

ArmMeasureValue (MEAN)Dispersion
Low MemoryChange in PTSD Checklist (PCL-5)9.25 change in units on a scaleStandard Deviation 20.37
Medium MemoryChange in PTSD Checklist (PCL-5)11.94 change in units on a scaleStandard Deviation 15.93
High MemoryChange in PTSD Checklist (PCL-5)15.91 change in units on a scaleStandard Deviation 15.1
Primary

Social Adjustment Scale-Self Report (SAS-SR)

Functional Status. Scored 1-5, with higher scores indicating worse functioning.

Time frame: Change from baseline to 12 weeks

Population: Groups based on baseline memory scores

ArmMeasureValue (MEAN)Dispersion
Low MemorySocial Adjustment Scale-Self Report (SAS-SR)0.14 change in units on a scaleStandard Deviation 0.56
Medium MemorySocial Adjustment Scale-Self Report (SAS-SR)0.10 change in units on a scaleStandard Deviation 0.41
High MemorySocial Adjustment Scale-Self Report (SAS-SR)0.38 change in units on a scaleStandard Deviation 0.42
Secondary

Veterans RAND 12 Item Health Survey Mental Component Summary (VR-12 MCS)

Mental Health-Related Quality of Life. Scores range from 0-100; higher values indicate better mental health-related quality of life.

Time frame: Change from baseline to 12 weeks

Population: Based on baseline memory scores

ArmMeasureValue (MEAN)Dispersion
Low MemoryVeterans RAND 12 Item Health Survey Mental Component Summary (VR-12 MCS)1.26 change in units on a scaleStandard Deviation 7.95
Medium MemoryVeterans RAND 12 Item Health Survey Mental Component Summary (VR-12 MCS)0.32 change in units on a scaleStandard Deviation 9.05
High MemoryVeterans RAND 12 Item Health Survey Mental Component Summary (VR-12 MCS)0.39 change in units on a scaleStandard Deviation 6.11

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026