Obsessive-Compulsive DisorderNCT01035242
"Association Splitting" in Obsessive-Compulsive Disorder (OCD)
A study testing "association splitting" and cognitive remediation in people with Obsessive-Compulsive Disorder, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- "association splitting" and cognitive remediation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2009to Jul 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Obsessive-Compulsive Disorder (OCD) with an Y-BOCS obsession subscore ≥ 8
Who cannot join
- intellectual disability (IQ < 70); unable to provide informed consent; severe neurological illness, psychotic symptoms or substance dependence.
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Medical Center Hamburg Eppendorf
Hamburg, Free and Hanseatic City of Hamburg, 20246
About this study
Official title: "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.
Read the 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.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- "association splitting", cognitive remediation
- Keywords
- OCD, obsessions, cognitive
- Medical subject headings
- Obsessive-Compulsive Disorder, Obsessive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"association splitting"Behavioural
"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 remediationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| "association splitting" | Experimental | Association splitting (6 sessions) delivered by psychologists. Receives: Behavioral: "association splitting" |
| cognitive remediation | Active comparator | CogPack training(6 sessions) delivered by either psychologists or psychology students at an advanced master level. Receives: Behavioral: cognitive remediation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total score of the Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Measured: 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)
Measured: 8 weeks, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2009 (estimated)
- Study startMar 2009
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obsessive-Compulsive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Collaborators
- German Research Foundation
- Responsible party
- Sponsor
- Investigators
- Lena Jelinek, PhD, Principal investigator, Universitätsklinikum Hamburg-EppendorfSteffen Moritz, PhD, Principal investigator, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01035242
- Sponsor's protocol ID
- JE 540/3-1
- Status last verified
- Mar 2015
- First submitted
- 17 Dec 2009
- Last updated
- 25 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24929782
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Association Splitting" Compared With Cognitive Remediation (CR) in Obsessive-compulsive Disorder (OCD): a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01035242
- Acronym / sponsor ID
- JE 540/3-1
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- OCD, obsessions, cognitive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Collaborators
- German Research Foundation
- Study start
- Mar 2009
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 18 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| "association splitting" | Experimental | Behavioral: "association splitting"Association splitting (6 sessions) delivered by psychologists. |
| cognitive remediation | Active comparator | Behavioral: cognitive remediationCogPack training(6 sessions) delivered by either psychologists or psychology students at an advanced master level. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Obsessive-Compulsive Disorder (OCD) with an Y-BOCS obsession subscore ≥ 8
Key exclusion criteria (1 listed)
- intellectual disability (IQ < 70); unable to provide informed consent; severe neurological illness, psychotic symptoms or substance dependence.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "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. | Behavioural | "association splitting" |
| cognitive remediationComputerized 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. | Behavioural | cognitive remediation |
Primary outcome
Total score of the Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Time frame: 8 weeks, 6 months
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2015.
- Results publication: PubMed 24929782Jelinek 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lena Jelinek, PhD principal investigator
Universitätsklinikum Hamburg-Eppendorf
Steffen Moritz, PhD principal investigator
Universitätsklinikum Hamburg-Eppendorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "association splitting" and cognitive remediation in people with Obsessive-Compulsive Disorder, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total score of the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) (time frame: 8 weeks, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01035242, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2015.