Posttraumatic Stress DisorderPhase 2NCT00764101
Attentional Bias Modification in Patients With Posttraumatic Stress Disorder
A Phase 2 study testing Attentional Bias Modification in people with Posttraumatic Stress Disorder, run by PsyQ at 1 site in Netherlands.
Trial summary
Randomized, placebo-controlled trial of 9 sessions of computerized attentional bias training on attentional bias and on symptoms of Posttraumatic Stress Disorder. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- Attentional Bias Modification
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2008to Apr 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Posttraumatic Stress Disorder
Who cannot join
- Diagnosis of psychosis, drug- or alcohol dependency/abuse;
- Unable to fill in questionnaires in Dutch;
- Color blindness (Stroop test).
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
PsyQ Haaglanden, department of psychotrauma
The Hague, South Holland, 2593 HR
About this study
Official title: Effects of Attentional Bias Modification on Attentional Bias and Symptoms of Posttraumatic Stress Disorder
Randomized, placebo-controlled trial of 9 sessions of computerized attentional bias training on attentional bias and on symptoms of Posttraumatic Stress Disorder.
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- Attentional Bias Modification
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Attentional Bias ModificationBehavioural
Also called Attentional Training
computerized training to reduce attentional bias in posttraumatic stress disorder
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 9 sessions of attentional bias modification (computerized training program) Receives: Behavioral: Attentional Bias Modification |
| 2 | Placebo comparator | Attentional control condition (placebo training program) Receives: Behavioral: Attentional Bias Modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician-Administered PTSD Scale (CAPS)
Measured: End of Trial + 3 week Follow-Up
Secondary outcomes (3)
PTSD symptoms (self-report)
Measured: end of trial + 3wk Follow Up
Attentional Bias (dot-probe test)
Measured: End of trial + 3wk Follow-up
Emotional Stroop Interference
Measured: End of trial + 3wk Follow Up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2008 (estimated)
- Study startSep 2008
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PsyQ
- Sponsor type
- University, hospital or other
- Collaborators
- Leiden University Medical Center, ZonMw: The Netherlands Organisation for Health Research and Development
- Investigators
- Willem van der Does, professor, Study director, Leiden UniversityMaartje Schoorl, MS, Principal investigator, PsyQ Nederland bv
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00764101
- Sponsor's protocol ID
- 60-60105-98-128
- Status last verified
- Jul 2011
- First submitted
- 29 Sep 2008
- Last updated
- 8 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23295710
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Attentional Bias Modification on Attentional Bias and Symptoms of Posttraumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT00764101
- Acronym / sponsor ID
- 60-60105-98-128
- Conditions
- Posttraumatic Stress Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- PsyQUniversity, hospital or other
- Collaborators
- Leiden University Medical Center, ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- Sep 2008
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 1 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized, placebo-controlled trial of 9 sessions of computerized attentional bias training on attentional bias and on symptoms of Posttraumatic Stress Disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Attentional Bias Modification9 sessions of attentional bias modification (computerized training program) |
| 2 | Placebo comparator | Behavioral: Attentional Bias ModificationAttentional control condition (placebo training program) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of Posttraumatic Stress Disorder
Key exclusion criteria (3 listed)
- Diagnosis of psychosis, drug- or alcohol dependency/abuse;
- Unable to fill in questionnaires in Dutch;
- Color blindness (Stroop test).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Attentional Bias ModificationAlso: Attentional Trainingcomputerized training to reduce attentional bias in posttraumatic stress disorder | Behavioural | 1, 2 |
Primary outcome
Clinician-Administered PTSD Scale (CAPS)
Time frame: End of Trial + 3 week Follow-Up
3 secondary outcomes
PTSD symptoms (self-report)
Time frame: end of trial + 3wk Follow Up
Attentional Bias (dot-probe test)
Time frame: End of trial + 3wk Follow-up
Emotional Stroop Interference
Time frame: End of trial + 3wk Follow Up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2011.
- Derived from this study: PubMed 23295710Schoorl 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Willem van der Does, professor study director
Leiden University
Maartje Schoorl, MS principal investigator
PsyQ Nederland bv
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Attentional Bias Modification in people with Posttraumatic Stress Disorder, run by PsyQ at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinician-Administered PTSD Scale (CAPS) (time frame: End of Trial + 3 week Follow-Up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00764101, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2011.