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Attentional Bias Modification in Patients With Posttraumatic Stress Disorder

Primary Purpose

Posttraumatic Stress Disorder

Status
Completed
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
Attentional Bias Modification
Sponsored by
PsyQ
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of Posttraumatic Stress Disorder

Exclusion Criteria:

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

Sites / Locations

  • PsyQ Haaglanden, department of psychotrauma

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

9 sessions of attentional bias modification (computerized training program)

Attentional control condition (placebo training program)

Outcomes

Primary Outcome Measures

Clinician-Administered PTSD Scale (CAPS)

Secondary Outcome Measures

PTSD symptoms (self-report)
Attentional Bias (dot-probe test)
Emotional Stroop Interference

Full Information

First Posted
September 29, 2008
Last Updated
July 7, 2011
Sponsor
PsyQ
Collaborators
Leiden University Medical Center, ZonMw: The Netherlands Organisation for Health Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT00764101
Brief Title
Attentional Bias Modification in Patients With Posttraumatic Stress Disorder
Official Title
Effects of Attentional Bias Modification on Attentional Bias and Symptoms of Posttraumatic Stress Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
PsyQ
Collaborators
Leiden University Medical Center, ZonMw: The Netherlands Organisation for Health Research and Development

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
9 sessions of attentional bias modification (computerized training program)
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Attentional control condition (placebo training program)
Intervention Type
Behavioral
Intervention Name(s)
Attentional Bias Modification
Other Intervention Name(s)
Attentional Training
Intervention Description
computerized training to reduce attentional bias in posttraumatic stress disorder
Primary Outcome Measure Information:
Title
Clinician-Administered PTSD Scale (CAPS)
Time Frame
End of Trial + 3 week Follow-Up
Secondary Outcome Measure Information:
Title
PTSD symptoms (self-report)
Time Frame
end of trial + 3wk Follow Up
Title
Attentional Bias (dot-probe test)
Time Frame
End of trial + 3wk Follow-up
Title
Emotional Stroop Interference
Time Frame
End of trial + 3wk Follow Up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of Posttraumatic Stress Disorder Exclusion Criteria: Diagnosis of psychosis, drug- or alcohol dependency/abuse; Unable to fill in questionnaires in Dutch; Color blindness (Stroop test).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Willem van der Does, professor
Organizational Affiliation
Leiden University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Maartje Schoorl, MS
Organizational Affiliation
PsyQ Nederland bv
Official's Role
Principal Investigator
Facility Information:
Facility Name
PsyQ Haaglanden, department of psychotrauma
City
Den Haag
State/Province
Zuid Holland
ZIP/Postal Code
2593 HR
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
23295710
Citation
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.
Results Reference
derived

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Attentional Bias Modification in Patients With Posttraumatic Stress Disorder

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