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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00764101
Other study ID # 60-60105-98-128
Secondary ID
Status Completed
Phase Phase 2
First received September 29, 2008
Last updated July 7, 2011
Start date September 2008
Est. completion date April 2010

Study information

Verified date July 2011
Source PsyQ
Contact n/a
Is FDA regulated No
Health authority Netherlands: Medical Ethics Review Committee (METC)
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date April 2010
Est. primary completion date April 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Intervention

Behavioral:
Attentional Bias Modification
computerized training to reduce attentional bias in posttraumatic stress disorder

Locations

Country Name City State
Netherlands PsyQ Haaglanden, department of psychotrauma Den Haag Zuid Holland

Sponsors (3)

Lead Sponsor Collaborator
PsyQ Leiden University Medical Center, ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Clinician-Administered PTSD Scale (CAPS) End of Trial + 3 week Follow-Up No
Secondary PTSD symptoms (self-report) end of trial + 3wk Follow Up No
Secondary Attentional Bias (dot-probe test) End of trial + 3wk Follow-up No
Secondary Emotional Stroop Interference End of trial + 3wk Follow Up No
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