Internet-delivered Attention Training for Obsessive-Compulsive Disorder

Obsessive-Compulsive Disorder Clinical Trial

Official title:

Internet-delivered Attention Training for Obsessive-Compulsive Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02018848
• Other study ID #: HU-ATP-OCD-2013
• Status: Completed
• Phase: N/A
• First received: November 28, 2013
• Last updated: November 11, 2014
• Start date: October 2013
• Est. completion date: July 2014

Study information

• Verified date: November 2014
• Source: Humboldt-Universität zu Berlin
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• diagnosis of primary OCD according to OCI-R self report (cut-off >=18)

Exclusion Criteria:

• 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.

Study Design

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

Related Conditions & MeSH terms

• Compulsive Behavior
• Obsessive-Compulsive Disorder

Intervention

Behavioral:
• Attention Training Program

Locations

Country	Name	City	State
Germany	Humboldt-Universität zu Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Humboldt-Universität zu Berlin

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Beck Anxiety Inventory (BAI) T1	The BAI measures severity of anxiety symptoms.	pre-treatment, estimated: between day 1 and day 7 after enrolment (no time limit set, all further steps relative to exact time point of T1 questionnaires)	No
Other	Beck Anxiety Inventory (BAI) T2	The BAI measures severity of anxiety symptoms.	post-treatment, between day 1 and 6 after T2 Bias Assessment (time limit set)	No
Other	Beck Anxiety Inventory (BAI) T3	The BAI measures severity of anxiety symptoms.	follow-up, between day 27 and 50 after T2 questionnaires (time limit set)	No
Other	Beck Depression Inventory II (BDI-II) T1	The BDI measures severity of depressive symptoms.	pre-treatment, estimated: between day 1 and day 7 after enrolment (no time limit set, all further steps relative to exact time point of T1 questionnaires)	No
Other	Beck Depression Inventory II (BDI-II) T2	The BDI measures severity of depressive symptoms.	post-treatment, between day 1 and 6 after T2 Bias Assessment (time limit set)	No
Other	Beck Depression Inventory II (BDI-II) T3	The BDI measures severity of depressive symptoms.	follow-up, between day 27 and 50 after T2 questionnaires (time limit set)	No
Other	Attention bias towards OCD-relevant stimuli at T1 measured with a dot-probe task.	Attention bias is measured using a dot-probe task. In this task pairs of pictures (OCD-relevant/neutral) are presented briefly on a computer screen. Next, a probe randomly appears on one of the two former picture locations. Participants have to react to that probe by pressing the corresponding button on the keyboard.; Attention bias is calculated as the mean difference in reaction times between trials in which the probe appears at the OCD-relevant location vs. trials in which it appears at the neutral location. The bias assessment session is masked as first training sessions in both groups.	after T1 questionnaires and pre-treatment, estimated: between day 1 and 3 after T1 questionnaires (no time limit set)	No
Other	Attention bias towards OCD-relevant stimuli at T2 measured with a dot-probe task.	Attention bias is measured using a dot-probe task. In this task pairs of pictures (OCD-relevant/neutral) are presented briefly on a computer screen. Next, a probe randomly appears on one of the two former picture locations. Participants have to react to that probe by pressing the corresponding button on the keyboard.; Attention bias is calculated as the mean difference in reaction times between trials in which the probe appears at the OCD-relevant location vs. trials in which it appears at the neutral location.	post-treatment, after a minimum of 8 training sessions over a time of 4 weeks, estimated: between day 1 and 4 after last training session (no time limit set)	No
Primary	Yale-Brown Obsessive-Compulsive Scale Self-Report Scale (Y-BOCS-SRS) T1	The Y-BOCS-SRS measures severity of OCD symptoms.	pre-treatment, estimated: between day 1 and day 7 after enrolment (no time limit set)	No
Primary	Yale-Brown Obsessive-Compulsive Scale Self-Report Scale (Y-BOCS-SRS) T2	The Y-BOCS-SRS measures severity of OCD symptoms.	post-treatment, between day 1 and 6 after T2 Bias Assessment (time limit set)	No
Primary	Yale-Brown Obsessive-Compulsive Scale Self-Report Scale (Y-BOCS-SRS) T3	The Y-BOCS-SRS measures severity of OCD symptoms.	follow-up, between day 27 and 50 after T2 questionnaires (time limit set)	No
Secondary	Obsessive-Compulsive Inventory-Revised (OCI-R) T1	The OCI-R measures severity of OCD symptoms.	pre-treatment, estimated: between day 1 and day 7 after enrolment (no time limit set)	No
Secondary	Obsessive-Compulsive Inventory-Revised (OCI-R) T2	The OCI-R measures severity of OCD symptoms.	post-treatment, between day 1 and 6 after T2 Bias Assessment (time limit set)	No
Secondary	Obsessive-Compulsive Inventory-Revised (OCI-R) T3	The OCI-R measures severity of OCD symptoms.	follow-up, between day 27 and 50 after T2 questionnaires (time limit set)	No

External Links

•   homepage for our online study