Post-Traumatic Stress DisorderPhase 1/2NCT02687555
The Role of Computerized Training in Post-Traumatic Stress Disorder
A Phase 1/2 study testing Cognitive Bias Modification of Appraisals (CBM-App) in people with Post-Traumatic Stress Disorder, run by Ruhr University of Bochum at 1 site in Germany.
Trial summary
The purpose of this study is to determine whether a computerized training, "Cognitive Bias Modification" targetting appraisals (CBM-App), can reduce dysfunctional appraisals of trauma in patients with Post-Traumatic Stress Disorder (PTSD), compared to a control condition. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Post-Traumatic Stress Disorder
- What is being tested?
- Cognitive Bias Modification of Appraisals (CBM-App)
- 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 siteGermany
- Study dates
- Feb 2016to May 2019
- Phase
- Phase 1/2
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Primary diagnosis of Post-Traumatic Stress Disorder according to ICD-10 (F43.1), and DSM-5 (as assessed via Clinician Adminstered PTSD Scale for DSM-5)
- motivated and willing to take part in the study (including questionnaire measures, computer training, filling out questionnaires after discharge)
- aged 18-60 years, male or female
- fluent in German
Who cannot join
- Substance abuse/ substance dependence currently or in the past six months
- active suicidal thoughts or intentions
- psychotic disorder (past or present)
- learning disability/ intellectual impairment
- red-green colour blindness
Trial locations and contacts
1 site in 1 country.
Germany1 site
Clinic for Psychosomatic Medicine and Psychotherapy, LWL University Clinic of Ruhr University of Bochum
Bochum, North Rhine-Westphalia, 44791
About this study
The purpose of this study is to determine whether a computerized training, "Cognitive Bias Modification" targetting appraisals (CBM-App), can reduce dysfunctional appraisals of trauma in patients with Post-Traumatic Stress Disorder (PTSD), compared to a control condition. Other outcomes measured include symptoms of PTSD and trauma-relevant dysfunctional cognitions. Participants are recruited from inpatients with PTSD admitted to the Clinic for Psychosomatic Medicine and Psychotherapy, LWL University Clinic of Ruhr University of Bochum.
- Conditions
- Post-Traumatic Stress Disorder
- Being tested
- Cognitive Bias Modification of Appraisals (CBM-App), Peripheral Vision Task (control condition)
- 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.
Cognitive Bias Modification of Appraisals (CBM-App)Behavioural
Peripheral Vision Task (control condition)Behavioural
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Computerized Cognitive Bias Modification of Appraisals (CBM-App), developed from that used by Woud et al. (2012,2013). The intervention comprises 8 sessions completed over a period of 2 weeks. The training takes place while participants are also receiving specialized inpatient treatment for PTSD at the Clinic for Psychosomatic Medicine and Psychotherapy, LWL University Clinic of Ruhr University of Bochum. Receives: Behavioral: Cognitive Bias Modification of Appraisals (CBM-App) |
| Control | Sham comparator | Computerized Peripheral Vision Task (PVT), developed from that used by Calkins et al. (2015). The intervention comprises 8 sessions completed over a period of 2 weeks. The training takes place while participants are also receiving specialized inpatient treatment for PTSD at the Clinic for Psychosomatic Medicine and Psychotherapy, LWL University Clinic of Ruhr University of Bochum. Receives: Behavioral: Peripheral Vision Task (control condition) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dysfunctional trauma-related appraisals as measured using an open-ended ambiguous scenarios task
Measured: Post-intervention (~ 2 weeks post-baseline)
Secondary outcomes (5)
Dysfunctional trauma-related appraisals as measured using an open-ended ambiguous scenarios task
Measured: Baseline, Mid-intervention (~1 week post-baseline), End of inpatient admission (~6 weeks post-baseline), 6 weeks post-discharge, 3 months post-discharge
Post-Traumatic Cognitions Inventory (PTCI)
The PTCI (Foa et al., 1999) is administered asking participants to report on their experience of post-traumatic cognitions in the previous week.
Measured: Baseline, Mid-intervention (~1 week post-baseline), Post-intervention (~2 weeks post-baseline), End of inpatient admission (~6 weeks post-baseline), 6 weeks post-discharge, 3 months post-discharge
PTSD Checklist for DSM-5 (PCL-5)
The PCL-5 (Weathers et al., 2013; German version by Ehring, Knaevelsrud, Krüger \& Schäfer) is administered asking participants to report on their experience of post-traumatic symptoms in the previous week.
Measured: Baseline, Mid-intervention (~1 week post-baseline), Post-intervention (~2 weeks post-baseline), End of inpatient admission (~6 weeks post-baseline), 6 weeks post-discharge, 3 months post-discharge
Intrusions Questionnaire
The intrusions questionnaire asks participants to report on the frequency and characteristics of intrusive memories of trauma in the preceding week
Measured: Baseline, Mid-intervention (~1 week post-baseline), Post-intervention (~2 weeks post-baseline), End of inpatient admission (~6 weeks post-baseline), 6 weeks post-discharge, 3 months post-discharge
Trauma Implicit Associations Test (IAT)
As developed by Lindgren et al. (2013)
Measured: Baseline, Post-intervention (~2 weeks post-baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionJan 2019
- Study completionMay 2019
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 Post-Traumatic 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruhr University of Bochum
- Sponsor type
- University, hospital or other
- Collaborators
- Daimler und Benz Stiftung, Technische Universität Dresden
- Responsible party
- Principal investigator, Marcella Woud, Ruhr University of Bochum
- Investigators
- Marcella L Woud, PhD, Principal investigator, Ruhr University of Bochum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02687555
- Sponsor's protocol ID
- 32-12/14
- Other IDs
- 204, 15-5477
- Status last verified
- Sep 2019
- First submitted
- 16 Feb 2016
- Last updated
- 17 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: It is planned to make individual participant data available on publication of the associated study results, via a publically-available data repository such as Open Science Framework. Data made available will be the research data reported in the publication, with the exception of any data that could compromise participant anonymity.
Publications
Woud ML, Blackwell SE, Cwik JC, Margraf J, Holmes EA, Steudte-Schmiedgen S, Herpertz S, Kessler H. Augmenting inpatient treatment for post-traumatic stress disorder with a computerised cognitive bias modification procedure targeting appraisals (CBM-App): protocol for a randomised controlled trial. BMJ Open. 2018 Jun 30;8(6):e019964. doi: 10.1136/bmjopen-2017-019964.
PubMed 29961004
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Computerized Training in Post-Traumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT02687555
- Acronym / sponsor ID
- 32-12/14
- Conditions
- Post-Traumatic Stress Disorder
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ruhr University of BochumUniversity, hospital or other
- Collaborators
- Daimler und Benz Stiftung, Technische Universität Dresden
- Study start
- Feb 2016 (actual)
- Primary completion
- Jan 2019 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 22 Feb 2016 (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.
The purpose of this study is to determine whether a computerized training, "Cognitive Bias Modification" targetting appraisals (CBM-App), can reduce dysfunctional appraisals of trauma in patients with Post-Traumatic Stress Disorder (PTSD), compared to a control condition. Other outcomes measured include symptoms of PTSD and trauma-relevant dysfunctional cognitions. Participants are recruited from inpatients with PTSD admitted to the Clinic for Psychosomatic Medicine and Psychotherapy, LWL University Clinic of Ruhr University of Bochum.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Cognitive Bias Modification of Appraisals (CBM-App)Computerized Cognitive Bias Modification of Appraisals (CBM-App), developed from that used by Woud et al. (2012,2013). The intervention comprises 8 sessions completed over a period of 2 weeks. The training takes place while participants are also receiving specialized inpatient treatment for PTSD at the Clinic for Psychosomatic Medicine and Psychotherapy, LWL University Clinic of Ruhr University of Bochum. |
| Control | Sham comparator | Behavioral: Peripheral Vision Task (control condition)Computerized Peripheral Vision Task (PVT), developed from that used by Calkins et al. (2015). The intervention comprises 8 sessions completed over a period of 2 weeks. The training takes place while participants are also receiving specialized inpatient treatment for PTSD at the Clinic for Psychosomatic Medicine and Psychotherapy, LWL University Clinic of Ruhr University of Bochum. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Primary diagnosis of Post-Traumatic Stress Disorder according to ICD-10 (F43.1), and DSM-5 (as assessed via Clinician Adminstered PTSD Scale for DSM-5)
- motivated and willing to take part in the study (including questionnaire measures, computer training, filling out questionnaires after discharge)
- aged 18-60 years, male or female
- fluent in German
Key exclusion criteria (5 listed)
- Substance abuse/ substance dependence currently or in the past six months
- active suicidal thoughts or intentions
- psychotic disorder (past or present)
- learning disability/ intellectual impairment
- red-green colour blindness
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 |
|---|---|---|
| Cognitive Bias Modification of Appraisals (CBM-App) | Behavioural | Intervention |
| Peripheral Vision Task (control condition) | Behavioural | Control |
Primary outcome
Dysfunctional trauma-related appraisals as measured using an open-ended ambiguous scenarios task
Time frame: Post-intervention (~ 2 weeks post-baseline)
5 secondary outcomes
Dysfunctional trauma-related appraisals as measured using an open-ended ambiguous scenarios task
Time frame: Baseline, Mid-intervention (~1 week post-baseline), End of inpatient admission (~6 weeks post-baseline), 6 weeks post-discharge, 3 months post-discharge
Post-Traumatic Cognitions Inventory (PTCI)
Time frame: Baseline, Mid-intervention (~1 week post-baseline), Post-intervention (~2 weeks post-baseline), End of inpatient admission (~6 weeks post-baseline), 6 weeks post-discharge, 3 months post-discharge
PTSD Checklist for DSM-5 (PCL-5)
Time frame: Baseline, Mid-intervention (~1 week post-baseline), Post-intervention (~2 weeks post-baseline), End of inpatient admission (~6 weeks post-baseline), 6 weeks post-discharge, 3 months post-discharge
Intrusions Questionnaire
Time frame: Baseline, Mid-intervention (~1 week post-baseline), Post-intervention (~2 weeks post-baseline), End of inpatient admission (~6 weeks post-baseline), 6 weeks post-discharge, 3 months post-discharge
Trauma Implicit Associations Test (IAT)
Time frame: Baseline, Post-intervention (~2 weeks post-baseline)
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 17 Sep 2019.
- Derived from this study: PubMed 29961004Woud ML, Blackwell SE, Cwik JC, Margraf J, Holmes EA, Steudte-Schmiedgen S, Herpertz S, Kessler H. Augmenting inpatient treatment for post-traumatic stress disorder with a computerised cognitive bias modification procedure targeting appraisals (CBM-App): protocol for a randomised controlled trial. BMJ Open. 2018 Jun 30;8(6):e019964. doi: 10.1136/bmjopen-2017-019964.
- Individual participant dataSharing planned: Yes. It is planned to make individual participant data available on publication of the associated study results, via a publically-available data repository such as Open Science Framework. Data made available will be the research data reported in the publication, with the exception of any data that could compromise participant anonymity.
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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.
Marcella L Woud, PhD principal investigator
Ruhr University of Bochum
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Cognitive Bias Modification of Appraisals (CBM-App) in people with Post-Traumatic Stress Disorder, run by Ruhr University of Bochum at 1 site in Germany.
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 4 inclusion and 5 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 17 Sep 2019. 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 Germany. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Dysfunctional trauma-related appraisals as measured using an open-ended ambiguous scenarios task (time frame: Post-intervention (~ 2 weeks post-baseline)). 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 NCT02687555, 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 17 Sep 2019.