NCT00764101

Brief Summary

Randomized, placebo-controlled trial of 9 sessions of computerized attentional bias training on attentional bias and on symptoms of Posttraumatic Stress Disorder.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2008

Geographic Reach
1 country

1 active site

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

September 1, 2008

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

September 29, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 1, 2008

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

July 8, 2011

Status Verified

July 1, 2011

Enrollment Period

1.6 years

First QC Date

September 29, 2008

Last Update Submit

July 7, 2011

Conditions

Posttraumatic Stress Disorder

Outcome Measures

Primary Outcomes (1)

  • Clinician-Administered PTSD Scale (CAPS)

    End of Trial + 3 week Follow-Up

Secondary Outcomes (3)

  • PTSD symptoms (self-report)

    end of trial + 3wk Follow Up

  • Attentional Bias (dot-probe test)

    End of trial + 3wk Follow-up

  • Emotional Stroop Interference

    End of trial + 3wk Follow Up

Study Arms (2)

1

EXPERIMENTAL

9 sessions of attentional bias modification (computerized training program)

Behavioral: Attentional Bias Modification

2

PLACEBO COMPARATOR

Attentional control condition (placebo training program)

Behavioral: Attentional Bias Modification

Interventions

Attentional Bias ModificationBEHAVIORAL

computerized training to reduce attentional bias in posttraumatic stress disorder

Also known as: Attentional Training
12

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of Posttraumatic Stress Disorder

You may not qualify if:

  • Diagnosis of psychosis, drug- or alcohol dependency/abuse;
  • Unable to fill in questionnaires in Dutch;
  • Color blindness (Stroop test).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PsyQ Haaglanden, department of psychotrauma

The Hague, South Holland, 2593 HR, Netherlands

Location

Related Publications (1)

  • Schoorl M, Putman P, Van Der Does W. Attentional bias modification in posttraumatic stress disorder: a randomized controlled trial. Psychother Psychosom. 2013;82(2):99-105. doi: 10.1159/000341920. Epub 2012 Dec 22.

    PMID: 23295710DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Willem van der Does, professor

    Leiden University

    STUDY DIRECTOR

  • Maartje Schoorl, MS

    PsyQ Nederland bv

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 29, 2008

First Posted

October 1, 2008

Study Start

September 1, 2008

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

July 8, 2011

Record last verified: 2011-07

Locations

NL(1)