NCT02018848

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 28, 2013

Completed
25 days until next milestone

First Posted

Study publicly available on registry

December 23, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

November 13, 2014

Status Verified

November 1, 2014

Enrollment Period

9 months

First QC Date

November 28, 2013

Last Update Submit

November 11, 2014

Conditions

Keywords

Obsessive-Compulsive DisorderAttention TrainingAttention Bias ModificationDot-Probe TaskRandomized Controlled TrialOnline TreatmentWashingChecking

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (3)

  • Obsessive-Compulsive Inventory-Revised (OCI-R) T1

    pre-treatment, estimated: between day 1 and day 7 after enrolment (no time limit set)

  • Obsessive-Compulsive Inventory-Revised (OCI-R) T2

    post-treatment, between day 1 and 6 after T2 Bias Assessment (time limit set)

  • Obsessive-Compulsive Inventory-Revised (OCI-R) T3

    follow-up, between day 27 and 50 after T2 questionnaires (time limit set)

Other Outcomes (8)

  • Beck Anxiety Inventory (BAI) T1

    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

    post-treatment, between day 1 and 6 after T2 Bias Assessment (time limit set)

  • Beck Anxiety Inventory (BAI) T3

    follow-up, between day 27 and 50 after T2 questionnaires (time limit set)

  • +5 more other outcomes

Study Arms (2)

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.

Behavioral: Attention Training Program

Interventions

Also known as: ATP, Attention Bias Modification Treatment, ABMT, Bias Modification, Attentional Training
Attention Training Program

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • suicidal
  • substance abuse or addiction
  • psychotic symptoms
  • visual impairment if not compensated with optical aid

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Humboldt-Universität zu Berlin

Berlin, State of Berlin, 10099, Germany

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Adenosine Triphosphate

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Adenine NucleotidesPurine NucleotidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNucleotidesNucleic Acids, Nucleotides, and NucleosidesRibonucleotides

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. phil. Dipl. Psych.

Study Record Dates

First Submitted

November 28, 2013

First Posted

December 23, 2013

Study Start

October 1, 2013

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

November 13, 2014

Record last verified: 2014-11

Locations