Internet-delivered Attention Training for Obsessive-Compulsive Disorder

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Dr. Andrea Ertle, Humboldt-Universität zu Berlin
ClinicalTrials.gov Identifier:
NCT02018848
First received: November 28, 2013
Last updated: March 7, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Obsessive-Compulsive Disorder
Behavioral: Attention Training Program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Internet-delivered Attention Training for Obsessive-Compulsive Disorder

Resource links provided by NLM:


Further study details as provided by Humboldt-Universität zu Berlin:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    The Y-BOCS-SRS measures severity of OCD symptoms.


Secondary Outcome Measures:
  • Obsessive-Compulsive Inventory-Revised (OCI-R) T1 [ Time Frame: pre-treatment, estimated: between day 1 and day 7 after enrolment (no time limit set) ] [ Designated as safety issue: No ]
    The OCI-R measures severity of OCD symptoms.

  • Obsessive-Compulsive Inventory-Revised (OCI-R) T2 [ Time Frame: post-treatment, between day 1 and 6 after T2 Bias Assessment (time limit set) ] [ Designated as safety issue: No ]
    The OCI-R measures severity of OCD symptoms.

  • Obsessive-Compulsive Inventory-Revised (OCI-R) T3 [ Time Frame: follow-up, between day 27 and 50 after T2 questionnaires (time limit set) ] [ Designated as safety issue: No ]
    The OCI-R measures severity of OCD symptoms.


Other Outcome Measures:
  • Beck Anxiety Inventory (BAI) T1 [ 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) ] [ Designated as safety issue: No ]
    The BAI measures severity of anxiety symptoms.

  • Beck Anxiety Inventory (BAI) T2 [ Time Frame: post-treatment, between day 1 and 6 after T2 Bias Assessment (time limit set) ] [ Designated as safety issue: No ]
    The BAI measures severity of anxiety symptoms.

  • Beck Anxiety Inventory (BAI) T3 [ Time Frame: follow-up, between day 27 and 50 after T2 questionnaires (time limit set) ] [ Designated as safety issue: No ]
    The BAI measures severity of anxiety symptoms.

  • Beck Depression Inventory II (BDI-II) T1 [ 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) ] [ Designated as safety issue: No ]
    The BDI measures severity of depressive symptoms.

  • Beck Depression Inventory II (BDI-II) T2 [ Time Frame: post-treatment, between day 1 and 6 after T2 Bias Assessment (time limit set) ] [ Designated as safety issue: No ]
    The BDI measures severity of depressive symptoms.

  • Beck Depression Inventory II (BDI-II) T3 [ Time Frame: follow-up, between day 27 and 50 after T2 questionnaires (time limit set) ] [ Designated as safety issue: No ]
    The BDI measures severity of depressive symptoms.

  • Attention bias towards OCD-relevant stimuli at T1 measured with a dot-probe task. [ Time Frame: after T1 questionnaires and pre-treatment, estimated: between day 1 and 3 after T1 questionnaires (no time limit set) ] [ Designated as safety issue: No ]

    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.


  • Attention bias towards OCD-relevant stimuli at T2 measured with a dot-probe task. [ 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) ] [ Designated as safety issue: No ]

    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.



Estimated Enrollment: 80
Study Start Date: October 2013
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • ATP
  • Attention Bias Modification Treatment
  • ABMT
  • Bias Modification
  • Attentional Training

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02018848

Locations
Germany
Humboldt-Universität zu Berlin
Berlin, Germany, 10099
Sponsors and Collaborators
Humboldt-Universität zu Berlin
  More Information

Additional Information:
No publications provided

Responsible Party: Dr. Andrea Ertle, Dr. phil. Dipl. Psych., Humboldt-Universität zu Berlin
ClinicalTrials.gov Identifier: NCT02018848     History of Changes
Other Study ID Numbers: HU-ATP-OCD-2013
Study First Received: November 28, 2013
Last Updated: March 7, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by Humboldt-Universität zu Berlin:
Obsessive-Compulsive Disorder
Attention Training
Attention Bias Modification
Dot-Probe Task
Randomized Controlled Trial
Online Treatment
Washing
Checking

Additional relevant MeSH terms:
Obsessive-Compulsive Disorder
Compulsive Personality Disorder
Anxiety Disorders
Mental Disorders
Personality Disorders

ClinicalTrials.gov processed this record on August 28, 2014