Obsessive-Compulsive DisorderNCT02018848
Internet-delivered Attention Training for Obsessive-Compulsive Disorder
A study testing Attention Training Program in people with Obsessive-Compulsive Disorder, run by Humboldt-Universität zu Berlin at 1 site in Germany.
Trial summary
The goal of this study is to investigate an attention training program for participants with Obsessive-Compulsive Disorder. The attention training consists of a modified dot probe task with picture stimuli related to washing and checking paired with neutral pictures. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- Attention Training Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2013to Jul 2014
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of primary OCD according to OCI-R self report (cut-off >=18)
Who cannot join
- suicidal
- substance abuse or addiction
- psychotic symptoms
- visual impairment if not compensated with optical aid
- Current treatment is not an exclusion criterion, but data on treatment status (current psycho- or pharmacotherapy for OCD) will enter our statistical analyses.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this study is to investigate an attention training program for participants with Obsessive-Compulsive Disorder. The attention training consists of a modified dot probe task with picture stimuli related to washing and checking paired with neutral pictures.
Participants are randomly assigned to an experimental and a placebo-control group. After a minimum of 4 weeks of attention training we expect to find differences between participants of the experimental and the control group in terms of attention bias, OCD symptoms, anxiety and depression.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- Attention Training Program
- Keywords
- Obsessive-Compulsive Disorder, Attention Training, Attention Bias Modification, Dot-Probe Task, Randomized Controlled Trial, Online Treatment, Washing, Checking
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Attention Training ProgramBehavioural
Also called ATP, Attention Bias Modification Treatment, ABMT, Bias Modification
| Study group | Role | What they receive |
|---|---|---|
| Attention Training Placebo | Placebo comparator | Same procedure, stimulus material, frequency and duration as in experimental group. The only difference: In the placebo group the probe randomly appears at one of the two locations on the screen so as not to train attention in any direction. Thus, the placebo training sessions are identical to the bias assessment sessions. |
| Attention Training Program | Experimental | The Attention Training consists of a modified dot-probe task. In this task pairs of pictures (OCD-relevant/neutral) are presented for 500 ms on a computer screen. Next, a probe appears on one of the two former picture locations. Participants have to react to that probe by pressing the corresponding button on the keyboard. One training session takes approximately 10 minutes in which 160 stimulus pairs are shown.
In the experimental group the probe always appears at the location of the neutral picture so as to train attention away from OCD-relevant stimuli.
Participants are asked to complete at least 2 training sessions per week over a period of 5 weeks. The first and last session are bias assessment sessions (see outcome measures), but participants stay blind to this. Receives: Behavioral: Attention Training Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Yale-Brown Obsessive-Compulsive Scale Self-Report Scale (Y-BOCS-SRS) T1
The Y-BOCS-SRS measures severity of OCD symptoms.
Measured: pre-treatment, estimated: between day 1 and day 7 after enrolment (no time limit set)
Yale-Brown Obsessive-Compulsive Scale Self-Report Scale (Y-BOCS-SRS) T2
The Y-BOCS-SRS measures severity of OCD symptoms.
Measured: post-treatment, between day 1 and 6 after T2 Bias Assessment (time limit set)
Yale-Brown Obsessive-Compulsive Scale Self-Report Scale (Y-BOCS-SRS) T3
The Y-BOCS-SRS measures severity of OCD symptoms.
Measured: follow-up, between day 27 and 50 after T2 questionnaires (time limit set)
Secondary outcomes (3)
Obsessive-Compulsive Inventory-Revised (OCI-R) T1
The OCI-R measures severity of OCD symptoms.
Measured: pre-treatment, estimated: between day 1 and day 7 after enrolment (no time limit set)
Obsessive-Compulsive Inventory-Revised (OCI-R) T2
The OCI-R measures severity of OCD symptoms.
Measured: post-treatment, between day 1 and 6 after T2 Bias Assessment (time limit set)
Obsessive-Compulsive Inventory-Revised (OCI-R) T3
The OCI-R measures severity of OCD symptoms.
Measured: follow-up, between day 27 and 50 after T2 questionnaires (time limit set)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2013 (estimated)
- Study startOct 2013
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive-Compulsive 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Humboldt-Universität zu Berlin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Andrea Ertle, Humboldt-Universität zu Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02018848
- Sponsor's protocol ID
- HU-ATP-OCD-2013
- Status last verified
- Nov 2014
- First submitted
- 28 Nov 2013
- Last updated
- 13 Nov 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-delivered Attention Training for Obsessive-Compulsive Disorder
- ClinicalTrials.gov ID
- NCT02018848
- Acronym / sponsor ID
- HU-ATP-OCD-2013
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- Obsessive-Compulsive Disorder, Attention Training, Attention Bias Modification, Dot-Probe Task, Randomized Controlled Trial, Online Treatment, Washing, Checking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Humboldt-Universität zu BerlinUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 23 Dec 2013 (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 goal of this study is to investigate an attention training program for participants with Obsessive-Compulsive Disorder. The attention training consists of a modified dot probe task with picture stimuli related to washing and checking paired with neutral pictures.
Participants are randomly assigned to an experimental and a placebo-control group. After a minimum of 4 weeks of attention training we expect to find differences between participants of the experimental and the control group in terms of attention bias, OCD symptoms, anxiety and depression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Attention Training Placebo | Placebo comparator | –Same procedure, stimulus material, frequency and duration as in experimental group. The only difference: In the placebo group the probe randomly appears at one of the two locations on the screen so as not to train attention in any direction. Thus, the placebo training sessions are identical to the bias assessment sessions. |
| Attention Training Program | Experimental | Behavioral: Attention Training ProgramThe Attention Training consists of a modified dot-probe task. In this task pairs of pictures (OCD-relevant/neutral) are presented for 500 ms on a computer screen. Next, a probe appears on one of the two former picture locations. Participants have to react to that probe by pressing the corresponding button on the keyboard. One training session takes approximately 10 minutes in which 160 stimulus pairs are shown. In the experimental group the probe always appears at the location of the neutral picture so as to train attention away from OCD-relevant stimuli. Participants are asked to complete at least 2 training sessions per week over a period of 5 weeks. The first and last session are bias assessment sessions (see outcome measures), but participants stay blind to this. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- diagnosis of primary OCD according to OCI-R self report (cut-off >=18)
Key exclusion criteria (5 listed)
- suicidal
- substance abuse or addiction
- psychotic symptoms
- visual impairment if not compensated with optical aid
- Current treatment is not an exclusion criterion, but data on treatment status (current psycho- or pharmacotherapy for OCD) will enter our statistical analyses.
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 |
|---|---|---|
| Attention Training ProgramAlso: ATP, Attention Bias Modification Treatment, ABMT, Bias Modification | Behavioural | Attention Training Program |
Primary outcome
Yale-Brown Obsessive-Compulsive Scale Self-Report Scale (Y-BOCS-SRS) T1
Time frame: pre-treatment, estimated: between day 1 and day 7 after enrolment (no time limit set)
The Y-BOCS-SRS measures severity of OCD symptoms.
Yale-Brown Obsessive-Compulsive Scale Self-Report Scale (Y-BOCS-SRS) T2
Time frame: post-treatment, between day 1 and 6 after T2 Bias Assessment (time limit set)
The Y-BOCS-SRS measures severity of OCD symptoms.
Yale-Brown Obsessive-Compulsive Scale Self-Report Scale (Y-BOCS-SRS) T3
Time frame: follow-up, between day 27 and 50 after T2 questionnaires (time limit set)
The Y-BOCS-SRS measures severity of OCD symptoms.
3 secondary outcomes
Obsessive-Compulsive Inventory-Revised (OCI-R) T1
Time frame: pre-treatment, estimated: between day 1 and day 7 after enrolment (no time limit set)
Obsessive-Compulsive Inventory-Revised (OCI-R) T2
Time frame: post-treatment, between day 1 and 6 after T2 Bias Assessment (time limit set)
Obsessive-Compulsive Inventory-Revised (OCI-R) T3
Time frame: follow-up, between day 27 and 50 after T2 questionnaires (time limit set)
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 13 Nov 2014.
Related trials for Obsessive-Compulsive Disorder
Enrolling by invitation
Family Accommodation Reduction in Adult Obsessive Compulsive Disorder: A Randomized Controlled Trial
Obsessive - Compulsive Disorder, Family Accommodation
Recruiting
Precision Analytic Research Methods in OCD
Obsessive Compulsive Disorder
Not yet recruitingObservational study
Investigation of Obsessive-Compulsive Disorder in Patients With Elbow Epicondylitis
Lateral Epicondylitis, Medial Epicondylitis
Recruiting
Focused Ultrasound for Behavioral Health
Depression, Anxiety
Not yet recruiting
Linear Accelerator Radiosurgical Anterior Capsulotomy With Task-based fMRI Identification of PERSonalized and PrEdictiVE Biomarkers of REsponse in Treatment-Refractory Obsessive-Compulsive Disorder (PERSEVERE Trial)
Treatment-refractory Obsessive-compulsive Disorder (trOCD)
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Attention Training Program in people with Obsessive-Compulsive Disorder, run by Humboldt-Universität zu Berlin 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 1 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 13 Nov 2014. 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.
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?
Yale-Brown Obsessive-Compulsive Scale Self-Report Scale (Y-BOCS-SRS) T1 (time frame: pre-treatment, estimated: between day 1 and day 7 after enrolment (no time limit set)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Nov 2014.