Cognition and Psychotherapy in PTSD

Posttraumatic Stress Disorder (PTSD) Clinical Trial

Official title:

Cognition and Psychotherapy in PTSD: Mechanisms and Functional Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03641924
• Other study ID #: D2699-R
• Status: Completed
• Start date: May 20, 2019
• Est. completion date: September 29, 2023

Study information

• Verified date: October 2023
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 139
• Est. completion date: September 29, 2023
• Est. primary completion date: September 29, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Posttraumatic Stress Disorder (PTSD)
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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

Locations

Country	Name	City	State
United States	Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in PTSD Checklist (PCL-5)	PTSD Symptoms. The range of the scale is from 0 (no symptoms) to 80 (maximal symptoms).	Baseline to 12 weeks
Primary	Social Adjustment Scale-Self Report (SAS-SR)	Functional Status. Scored 1-5, with higher scores indicating worse functioning.	Baseline to 12 weeks
Secondary	Veterans RAND 12 Item Health Survey (VR-12)	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