Enhancement of PTSD Treatment With Computerized Executive Function Training

NCT03260127 | Completed Results DMC

• 2 other identifiers: F2459-WIK2RX002459
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

This study focuses on helping Iraq and Afghanistan Veterans with posttraumatic stress disorder (PTSD) benefit fully from therapy by first enhancing their thinking abilities. PTSD has been associated with thinking problems, including difficulty planning/organizing, thinking flexibly, and inhibiting distracting emotional information. There is some evidence that computerized training programs are helpful for improving thinking. Therefore, this study tests whether computerized cognitive training will in fact improve individuals' thinking abilities and if this will in turn improve PTSD treatment outcomes and lead to more individuals completing treatment and showing greater improvements in emotional symptoms and quality of life than standard therapy (when paired with a word training condition).

Conditions

Posttraumatic Stress Disorder

Keywords

PTSD; treatment; posttraumatic stress disorder; therapy; cognition; thinking; executive function; computer; training

Outcome Measures

Primary Outcomes (7)

• Wisconsin Card Sorting Test (WCST)

  Wisconsin Card Sorting Test (WCST) is a neuropsychological measure of executive functioning, will be examined separately as well as in a composite with the other neuropsychological measures of executive functioning, range: -22 to 15, higher scores mean a worse outcome

  change from baseline to completion of computerized cognitive training (6 weeks)

• Paced Auditory Serial Addition Test (PASAT)

  Paced Auditory Serial Addition Test (PASAT) is a neuropsychological measure of executive functioning, will be examined separately as well as in a composite with the other neuropsychological measures of executive functioning, range: -22 to 47, higher scores mean a better outcome

  change from baseline to completion of computerized cognitive training (6 weeks)

• Delis Kaplan Executive Function System (D-KEFS)

  Delis Kaplan Executive Function System (D-KEFS) is a neuropsychological measure of executive functioning, will be examined separately as well as in a composite with the other neuropsychological measures of executive functioning, range: -39 to 27, higher scores mean a worse outcome

  change from baseline to completion of computerized cognitive training (6 weeks)

• Behavior Rating Inventory of Executive Function (BRIEF)

  Behavior Rating Inventory of Executive Function (BRIEF) is a self-report measure of executive functioning, items are summed to create a total score, range: -32 to 30, higher scores mean a worse outcome

  change in subjective executive functioning from baseline to completion of computerized cognitive training (6 weeks)

• WAIS-IV Digit Span Sequencing Subtest

  Wechsler Adult Intelligence Scale, Fourth Edition (WAIS-IV) Digit Span Sequencing subtest is a neuropsychological measure of executive functioning, will be examined separately as well as in a composite with the other neuropsychological measures of executive functioning, range: -3 to 3, higher scores mean a better outcome

  change from baseline to completion of computerized cognitive training (6 weeks)

• N-Back Task Performance

  N-Back is a task that tests executive functioning, range: -.25 to .28, higher scores means a better outcome

  change from baseline to completion of computerized cognitive training (6 weeks)

• Go/No-Go Task Performance

  Go/No-Go is a task that tests executive functioning, range: -.04 to .02, higher scores mean a worse outcome

  change from baseline to completion of computerized cognitive training (6 weeks)

Secondary Outcomes (5)

• Clinician-Administered PTSD Scale for DSM 5 (CAPS-5)

  change in PTSD symptoms from baseline to completion of Cognitive Processing Therapy (12 sessions completed after cognitive training), approximately 12 weeks after baseline assessment

• PTSD Checklist for DSM-5 (PCL-5)

  change in PTSD symptoms from baseline to completion of Cognitive Processing Therapy (12 sessions completed after cognitive training), approximately 12 weeks after baseline assessment

• World Health Organization Quality of Life - BREF

  change in quality of life from baseline to completion of Cognitive Processing Therapy (12 sessions completed after cognitive training), approximately 12 weeks after baseline assessment

• Time (in Minutes) Spent Completing Cognitive Processing Therapy Homework

  time (in minutes) spent completing homework from CPT session 1 to CPT session 12 (across approximately 6 weeks, weeks 7-12 after baseline)

• Number of CPT Sessions Completed

  CPT sessions completed (out of a possible 12) after completing the cognitive training (across approximately 6 weeks, weeks 7-12 after baseline)

Study Arms (2)

CEFT-CPT

EXPERIMENTAL

Computerized executive function training plus Cognitive Processing Therapy for PTSD

Behavioral: Computerized executive function training plus CPT (CEFT-CPT)

WT-CPT

ACTIVE COMPARATOR

Word game training plus Cognitive Processing Therapy for PTSD

Behavioral: Word game training plus CPT (WT-CPT)

Interventions

Computerized executive function training plus CPT (CEFT-CPT) BEHAVIORAL

Participants randomized to the CEFT-CPT arm will receive 6 weeks of computerized executive function training and then 6 weeks of standard Cognitive Processing Therapy for PTSD (total of 12 sessions)

CEFT-CPT

Word game training plus CPT (WT-CPT) BEHAVIORAL

Participants randomized to the WT-CPT arm will receive 6 weeks of computerized word game training and then 6 weeks of standard Cognitive Processing Therapy for PTSD (total of 12 sessions)

WT-CPT

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF) Veterans enrolled at Veterans Affairs San Diego Healthcare System (VASDHS)
• aged 18-55
• current posttraumatic stress disorder (PTSD) diagnosis
• endorsement of cognitive complaints
• no pending medication changes
• English-speaking.

You may not qualify if:

• active substance use disorder in the last month
• suicidal intent or attempt within the last month
• schizophrenia, psychotic disorder and/or bipolar disorder
• dementia
• premorbid IQ \< 70
• participation in other concurrent PTSD intervention studies
• previous completion of more than 4 Cognitive Processing Therapy (CPT) sessions
• history of a documented neurological disorder (e.g., Parkinson's disease, multiple sclerosis, epilepsy)
• moderate to severe traumatic brain injury (TBI) (i.e., loss of consciousness greater than 30 minutes or post-traumatic amnesia greater than 24 hours).

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA San Diego Healthcare System, San Diego, CA

San Diego, California, 92161, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

2-cyclohexylidenhydrazo-4-phenyl-thiazole

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Results Point of Contact

• Title: Laura Crocker
• Organization: VA San Diego Healthcare System

laura.crocker@va.gov

8586426484

Study Officials

• Laura D. Crocker, PhD

  VA San Diego Healthcare System, San Diego, CA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2017
• First Posted: August 24, 2017
• Study Start: July 2, 2018
• Primary Completion: September 30, 2022
• Study Completion: October 31, 2022
• Last Updated: April 1, 2024
• Results First Posted: April 1, 2024

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)