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

Primary Purpose

Obsessive-Compulsive Disorder

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
"association splitting"
cognitive remediation
Sponsored by
Universitätsklinikum Hamburg-Eppendorf
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obsessive-Compulsive Disorder focused on measuring OCD, obsessions, cognitive

Eligibility Criteria

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

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.

Sites / Locations

  • University Medical Center Hamburg Eppendorf

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

"association splitting"

cognitive remediation

Arm Description

Association splitting (6 sessions) delivered by psychologists.

CogPack training(6 sessions) delivered by either psychologists or psychology students at an advanced master level.

Outcomes

Primary Outcome Measures

Total score of the Yale-Brown Obsessive Compulsive Scale (Y-BOCS)

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)

Full Information

First Posted
December 17, 2009
Last Updated
March 24, 2015
Sponsor
Universitätsklinikum Hamburg-Eppendorf
Collaborators
German Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01035242
Brief Title
"Association Splitting" in Obsessive-Compulsive Disorder (OCD)
Official Title
"Association Splitting" Compared With Cognitive Remediation (CR) in Obsessive-compulsive Disorder (OCD): a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitätsklinikum Hamburg-Eppendorf
Collaborators
German Research Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive-Compulsive Disorder
Keywords
OCD, obsessions, cognitive

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
"association splitting"
Arm Type
Experimental
Arm Description
Association splitting (6 sessions) delivered by psychologists.
Arm Title
cognitive remediation
Arm Type
Active Comparator
Arm Description
CogPack training(6 sessions) delivered by either psychologists or psychology students at an advanced master level.
Intervention Type
Behavioral
Intervention Name(s)
"association splitting"
Intervention Description
"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.
Intervention Type
Behavioral
Intervention Name(s)
cognitive remediation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Total score of the Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Time Frame
8 weeks, 6 months
Secondary Outcome Measure Information:
Title
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

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: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lena Jelinek, PhD
Organizational Affiliation
Universitätsklinikum Hamburg-Eppendorf
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Steffen Moritz, PhD
Organizational Affiliation
Universitätsklinikum Hamburg-Eppendorf
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Center Hamburg Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
24929782
Citation
Jelinek L, Hauschildt M, Hottenrott B, Kellner M, Moritz S. Further evidence for biased semantic networks in obsessive-compulsive disorder (OCD): when knives are no longer associated with buttering bread but only with stabbing people. J Behav Ther Exp Psychiatry. 2014 Dec;45(4):427-34. doi: 10.1016/j.jbtep.2014.05.002. Epub 2014 May 24.
Results Reference
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"Association Splitting" in Obsessive-Compulsive Disorder (OCD)

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