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

Obsessive-Compulsive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01035242
• Other study ID #: JE 540/3-1
• Status: Completed
• Phase: N/A
• First received: December 17, 2009
• Last updated: March 24, 2015
• Start date: March 2009
• Est. completion date: July 2012

Study information

• Verified date: March 2015
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Compulsive Behavior
• Obsessive-Compulsive Disorder

Intervention

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.
• 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.

Locations

Country	Name	City	State
Germany	University Medical Center Hamburg Eppendorf	Hamburg

Sponsors (2)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf	German Research Foundation

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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 Psy — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total score of the Yale-Brown Obsessive Compulsive Scale (Y-BOCS)		8 weeks, 6 months	No
Secondary	Obsession subscore of the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) and the total score of the Obsessive-Compulsive Inventory (OCI-R)		8 weeks, 6 months	No