NCT01035242

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
156

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2009

Longer than P75 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

March 1, 2009

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 17, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 18, 2009

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

March 25, 2015

Status Verified

March 1, 2015

Enrollment Period

3.3 years

First QC Date

December 17, 2009

Last Update Submit

March 24, 2015

Conditions

Obsessive-Compulsive Disorder

Keywords

OCDobsessionscognitive

Outcome Measures

Primary Outcomes (1)

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

    8 weeks, 6 months

Secondary Outcomes (1)

  • 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

Study Arms (2)

"association splitting"

EXPERIMENTAL

Association splitting (6 sessions) delivered by psychologists.

Behavioral: "association splitting"

cognitive remediation

ACTIVE COMPARATOR

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

Behavioral: cognitive remediation

Interventions

"association splitting"BEHAVIORAL

"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.

"association splitting"
cognitive remediationBEHAVIORAL

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.

cognitive remediation

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Hamburg Eppendorf

Hamburg, Hamburg, 20246, Germany

Location

Related 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 Psychiatry. 2014 Dec;45(4):427-34. doi: 10.1016/j.jbtep.2014.05.002. Epub 2014 May 24.

    PMID: 24929782RESULT

MeSH Terms

Conditions

Obsessive-Compulsive DisorderObsessive Behavior

Interventions

Cognitive Remediation

Condition Hierarchy (Ancestors)

Anxiety DisordersMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Lena Jelinek, PhD

    Universitätsklinikum Hamburg-Eppendorf

    PRINCIPAL INVESTIGATOR

  • Steffen Moritz, PhD

    Universitätsklinikum Hamburg-Eppendorf

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2009

First Posted

December 18, 2009

Study Start

March 1, 2009

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

March 25, 2015

Record last verified: 2015-03

Locations

DE(1)