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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by Universitätsklinikum Hamburg-Eppendorf.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
German Research Foundation
Information provided by:
Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier:
NCT01035242
First received: December 17, 2009
Last updated: NA
Last verified: December 2009
History: No changes posted
  Purpose

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.


Condition Intervention
Obsessive-Compulsive Disorder
Behavioral: "association splitting"
Behavioral: cognitive remediation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: "Association Splitting" Compared With Cognitive Remediation (CR) in Obsessive-compulsive Disorder (OCD): a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Universitätsklinikum Hamburg-Eppendorf:

Primary Outcome Measures:
  • Total score of the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) [ Time Frame: 8 weeks, 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: March 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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" or "blood - contamination") 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"; "blood - Snow White ("lips as red as blood")", or "blood - blood bond"). 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.

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.

  Eligibility

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

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.
  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: NCT01035242

Contacts
Contact: Lena Jelinek, PhD +49407410 ext 57539 ljelinek@uke.uni-hamburg.de
Contact: Steffen Moritz, PhD +49407410 ext 56565 moritz@uke.uni-hamburg.de

Locations
Germany
University Medical Center Hamburg Eppendorf Recruiting
Hamburg, Germany, 20246
Contact: Lena Jelinek, PhD    +49407410 ext 57539      
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
German Research Foundation
Investigators
Principal Investigator: Lena Jelinek, PhD Universitätsklinikum Hamburg-Eppendorf
Principal Investigator: Steffen Moritz, PhD Universitätsklinikum Hamburg-Eppendorf
  More Information

Additional Information:
No publications provided

Responsible Party: Lena Jelinek, PhD and Steffen Moritz, PhD, Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT01035242     History of Changes
Other Study ID Numbers: JE 540/3-1
Study First Received: December 17, 2009
Last Updated: December 17, 2009
Health Authority: Germany: Ministry of Health

Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
OCD
obsessions
cognitive

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

ClinicalTrials.gov processed this record on July 24, 2014