"Association Splitting" in Obsessive-Compulsive Disorder (OCD)

March 24, 2015 updated by: Universitätsklinikum Hamburg-Eppendorf

"Association Splitting" Compared With Cognitive Remediation (CR) in Obsessive-compulsive Disorder (OCD): a Randomized Controlled Trial

Over a period of 3 weeks, association splitting is compared to cognitive remediation (CogPack training) as an add-on intervention to cognitive-behavioral therapy (CBT). Blind to treatment assignment, both groups are assessed before intervention and eight weeks as well as six months later with the Yale-Brown Obsessive Compulsive Scale (Y-BOCS), the Obsessive-Compulsive Inventory (OCI-R) and cognitive tests. OCD severity as measured by the Y-BOCS total score serves as the primary outcome parameter. It is assumed that association splitting will improve OCD severity to a greater extent than cognitive remediation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Association splitting is a new cognitive technique which aims at reducing obsessive thoughts. It draws upon the so-called "fan effect" of associative priming. Transposing this principle to the treatment of obsessive-compulsive disorder (OCD), we hypothesized that the sprouting of new and the strengthening of existing neutral associations to core OCD cognitions will reduce their fear-evoking properties by depriving the chain of OCD-related cognitions of associative strength. Patients with OCD are randomly allocated to either associations splitting (AS) or cognitive remediation (CogPack training). Blind to treatment assignment, both groups are assessed before intervention and eight weeks as well as six months later with the Yale-Brown Obsessive Compulsive Scale (Y-BOCS), the Obsessive-Compulsive Inventory (OCI-R) and cognitive tests. OCD severity derived from the Y-BOCS and the OCI-R serves as the main outcome parameters. We also explore if AS changes the OCD-related semantic networks with cognitive tasks. It is assumed that association splitting will improve OCD severity to a greater extent than CogPack training.

Study Type

Interventional

Enrollment (Actual)

156

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hamburg, Germany, 20246
        • University Medical Center Hamburg Eppendorf

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Obsessive-Compulsive Disorder (OCD) with an Y-BOCS obsession subscore ≥ 8

Exclusion Criteria:

  • intellectual disability (IQ < 70); unable to provide informed consent; severe neurological illness, psychotic symptoms or substance dependence.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: "association splitting"
Association splitting (6 sessions) delivered by psychologists.
Behavioral: "association splitting"
"Association splitting" is a cognitive intervention which aims at reducing obsessive thoughts. Association splitting is based on the so called fan effect (Anderson, 1974) and aims at reducing the strength of obsessive cognitions. For this purpose core intrusive thoughts are identified with the patient (such as "cancer - illness") and the patient is encouraged to find non-OCD associations that are (semantically or phonologically) related to the OCD cognition (such as "cancer - (zodiac) sign", "cancer - great crab"). To strengthen the novel connections, these associations are elaborated by the use of pictures, music, or smells. By enhancing OC-unrelated associations it is assumed that the influence of OC-related concepts is weakened.
Active Comparator: cognitive remediation
CogPack training(6 sessions) delivered by either psychologists or psychology students at an advanced master level.
Behavioral: cognitive remediation
Computerized cognitive remediation (CogPack training). A fixed sequence is administered, which covers a wide range of neuropsychological exercises involving memory, reasoning, selective attention and psychomotor speed. The difficulty level for each patient is adapted automatically depending on to the subject's performance on prior exercises. At the end of each session, the patient receives individual feedback on his or her performance. To match with association splitting, six sessions are administered. Each session lasts approximately 45-60 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Total score of the Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Time Frame: 8 weeks, 6 months
8 weeks, 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Obsession subscore of the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) and the total score of the Obsessive-Compulsive Inventory (OCI-R)
Time Frame: 8 weeks, 6 months
8 weeks, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Collaborators

German Research Foundation

Investigators

  • Principal Investigator: Lena Jelinek, PhD, Universitatsklinikum Hamburg-Eppendorf
  • Principal Investigator: Steffen Moritz, PhD, Universitatsklinikum Hamburg-Eppendorf

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

December 17, 2009

First Submitted That Met QC Criteria

December 17, 2009

First Posted (Estimate)

December 18, 2009

Study Record Updates

Last Update Posted (Estimate)

March 25, 2015

Last Update Submitted That Met QC Criteria

March 24, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JE 540/3-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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