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Internet-delivered Attention Training for Obsessive-Compulsive Disorder

Primary Purpose

Obsessive-Compulsive Disorder

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Attention Training Program
Sponsored by
Humboldt-Universität zu Berlin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obsessive-Compulsive Disorder focused on measuring Obsessive-Compulsive Disorder, Attention Training, Attention Bias Modification, Dot-Probe Task, Randomized Controlled Trial, Online Treatment, Washing, Checking

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Humboldt-Universität zu Berlin

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Attention Training Placebo

Attention Training Program

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Yale-Brown Obsessive-Compulsive Scale Self-Report Scale (Y-BOCS-SRS) T1
The Y-BOCS-SRS measures severity of OCD symptoms.
Yale-Brown Obsessive-Compulsive Scale Self-Report Scale (Y-BOCS-SRS) T2
The Y-BOCS-SRS measures severity of OCD symptoms.
Yale-Brown Obsessive-Compulsive Scale Self-Report Scale (Y-BOCS-SRS) T3
The Y-BOCS-SRS measures severity of OCD symptoms.

Secondary Outcome Measures

Obsessive-Compulsive Inventory-Revised (OCI-R) T1
The OCI-R measures severity of OCD symptoms.
Obsessive-Compulsive Inventory-Revised (OCI-R) T2
The OCI-R measures severity of OCD symptoms.
Obsessive-Compulsive Inventory-Revised (OCI-R) T3
The OCI-R measures severity of OCD symptoms.

Full Information

First Posted
November 28, 2013
Last Updated
November 11, 2014
Sponsor
Humboldt-Universität zu Berlin
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1. Study Identification

Unique Protocol Identification Number
NCT02018848
Brief Title
Internet-delivered Attention Training for Obsessive-Compulsive Disorder
Official Title
Internet-delivered Attention Training for Obsessive-Compulsive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Humboldt-Universität zu Berlin

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive-Compulsive Disorder
Keywords
Obsessive-Compulsive Disorder, Attention Training, Attention Bias Modification, Dot-Probe Task, Randomized Controlled Trial, Online Treatment, Washing, Checking

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Attention Training Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Attention Training Program
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Attention Training Program
Other Intervention Name(s)
ATP, Attention Bias Modification Treatment, ABMT, Bias Modification, Attentional Training
Primary Outcome Measure Information:
Title
Yale-Brown Obsessive-Compulsive Scale Self-Report Scale (Y-BOCS-SRS) T1
Description
The Y-BOCS-SRS measures severity of OCD symptoms.
Time Frame
pre-treatment, estimated: between day 1 and day 7 after enrolment (no time limit set)
Title
Yale-Brown Obsessive-Compulsive Scale Self-Report Scale (Y-BOCS-SRS) T2
Description
The Y-BOCS-SRS measures severity of OCD symptoms.
Time Frame
post-treatment, between day 1 and 6 after T2 Bias Assessment (time limit set)
Title
Yale-Brown Obsessive-Compulsive Scale Self-Report Scale (Y-BOCS-SRS) T3
Description
The Y-BOCS-SRS measures severity of OCD symptoms.
Time Frame
follow-up, between day 27 and 50 after T2 questionnaires (time limit set)
Secondary Outcome Measure Information:
Title
Obsessive-Compulsive Inventory-Revised (OCI-R) T1
Description
The OCI-R measures severity of OCD symptoms.
Time Frame
pre-treatment, estimated: between day 1 and day 7 after enrolment (no time limit set)
Title
Obsessive-Compulsive Inventory-Revised (OCI-R) T2
Description
The OCI-R measures severity of OCD symptoms.
Time Frame
post-treatment, between day 1 and 6 after T2 Bias Assessment (time limit set)
Title
Obsessive-Compulsive Inventory-Revised (OCI-R) T3
Description
The OCI-R measures severity of OCD symptoms.
Time Frame
follow-up, between day 27 and 50 after T2 questionnaires (time limit set)
Other Pre-specified Outcome Measures:
Title
Beck Anxiety Inventory (BAI) T1
Description
The BAI measures severity of anxiety symptoms.
Time Frame
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)
Title
Beck Anxiety Inventory (BAI) T2
Description
The BAI measures severity of anxiety symptoms.
Time Frame
post-treatment, between day 1 and 6 after T2 Bias Assessment (time limit set)
Title
Beck Anxiety Inventory (BAI) T3
Description
The BAI measures severity of anxiety symptoms.
Time Frame
follow-up, between day 27 and 50 after T2 questionnaires (time limit set)
Title
Beck Depression Inventory II (BDI-II) T1
Description
The BDI measures severity of depressive symptoms.
Time Frame
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)
Title
Beck Depression Inventory II (BDI-II) T2
Description
The BDI measures severity of depressive symptoms.
Time Frame
post-treatment, between day 1 and 6 after T2 Bias Assessment (time limit set)
Title
Beck Depression Inventory II (BDI-II) T3
Description
The BDI measures severity of depressive symptoms.
Time Frame
follow-up, between day 27 and 50 after T2 questionnaires (time limit set)
Title
Attention bias towards OCD-relevant stimuli at T1 measured with a dot-probe task.
Description
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.
Time Frame
after T1 questionnaires and pre-treatment, estimated: between day 1 and 3 after T1 questionnaires (no time limit set)
Title
Attention bias towards OCD-relevant stimuli at T2 measured with a dot-probe task.
Description
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.
Time Frame
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Humboldt-Universität zu Berlin
City
Berlin
ZIP/Postal Code
10099
Country
Germany

12. IPD Sharing Statement

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Internet-delivered Attention Training for Obsessive-Compulsive Disorder

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