Internet-delivered Attention Training for Obsessive-Compulsive Disorder

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 Overview

• Status: Completed
• Conditions: Obsessive-Compulsive Disorder
• Intervention / Treatment: Behavioral: Attention Training Program

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10099
    • Humboldt-Universität zu Berlin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Attention Training Placebo; 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.
Experimental: Attention Training Program; 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.	Behavioral: Attention Training Program; Other Names: ABMT; ATP; Attention Bias Modification Treatment; Bias Modification; Attentional Training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: Humboldt-Universität zu Berlin

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: November 28, 2013
• First Submitted That Met QC Criteria: December 17, 2013
• First Posted (Estimate): December 23, 2013

Study Record Updates

• Last Update Posted (Estimate): November 13, 2014
• Last Update Submitted That Met QC Criteria: November 11, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: Randomized Controlled Trial; Obsessive-Compulsive Disorder; Attention Bias Modification; Attention Training; Online Treatment; Dot-Probe Task; Washing; Checking
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Personality Disorders; Anxiety Disorders; Disease; Compulsive Personality Disorder; Obsessive-Compulsive Disorder
• Other Study ID Numbers: HU-ATP-OCD-2013