NCT02139137

Brief Summary

The study is designed to evaluate the effect of a novel computer training program on PTSD.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2010

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 12, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 15, 2014

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

March 7, 2017

Completed
Last Updated

November 6, 2017

Status Verified

October 1, 2017

Enrollment Period

3.6 years

First QC Date

May 12, 2014

Results QC Date

November 8, 2016

Last Update Submit

October 4, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in Clinician Administered PTSD Scale; Re-experiencing

    Model estimations of the means and standard deviation of posttreatment score at the mean level of baseline severity reported below. Scale range: 0-40, higher values indicate greater symptom severity

    Baseline, Week 4

Secondary Outcomes (4)

  • Clinician Administered PTSD Scale Total Score - Responder Status

    Week 4

  • Change in Depression: Beck Depression Inventory

    Baseline, Week 4

  • Change in General Anxiety: Spielberger State-Trait Anxiety Inventory

    Baseline, Week 4

  • Change in Functional Impairment; Sheehan Disability Scale

    Baseline, Week 4

Study Arms (2)

High Interference Control Condition

EXPERIMENTAL

Computerized training program requiring participants to repeatedly practice controlling interference on a cognitive task

Other: Computerized Cognitive Training - active

Low Interference Control Condition

ACTIVE COMPARATOR

Computerized training program requiring participants to minimally practice controlling interference on a cognitive task

Other: Computerized cognitive training - sham

Interventions

Cognitive training using working memory span task

High Interference Control Condition

Sham training condition

Low Interference Control Condition

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female
  • Age 18-65
  • Primary DSM-IV diagnosis of PTSD secondary to sexual trauma

You may not qualify if:

  • Current trauma or PTSD-focused psychosocial treatment
  • Active suicidality, evidence of substance dependence in the past 6 months
  • Evidence of current or past schizophrenia
  • Bipolar disorder
  • Organic mental disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Bomyea J, Stein MB, Lang AJ. Interference control training for PTSD: A randomized controlled trial of a novel computer-based intervention. J Anxiety Disord. 2015 Aug;34:33-42. doi: 10.1016/j.janxdis.2015.05.010. Epub 2015 Jun 10.

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Results Point of Contact

Title
Jessica Bomyea
Organization
SDSU/UCSD Joint Doctoral Program in Clinical Psychology

Study Officials

  • Jessica A Bomyea, M.S.

    San Diego State University/University of California, San Diego

    PRINCIPAL INVESTIGATOR
  • Ariel J Lang, Ph.D.

    University of California, San Diego

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director of Research Affairs

Study Record Dates

First Submitted

May 12, 2014

First Posted

May 15, 2014

Study Start

January 1, 2010

Primary Completion

August 1, 2013

Study Completion

December 1, 2013

Last Updated

November 6, 2017

Results First Posted

March 7, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share