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06 February 2012
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| [ Print-friendly version ] |
| DClinPsy: Maladaptive cognitive processes during exposure in people with OCD (checking subtype) |
| ISRCTN | ISRCTN60061491 |
| ClinicalTrials.gov identifier | |
| Public title | DClinPsy: Maladaptive cognitive processes during exposure in people with OCD (checking subtype) |
| Scientific title | |
| Acronym | N/A |
| Serial number at source | N0266190334 |
| Study hypothesis | The research aims to identify covert cognitive strategies that are used by individuals with Obsessive Compulsive Disorder (checking subtype) (OCD) when they are exposed to fear provoking stimuli. The principle objective is to increase our understanding of OCD and to refine and improve cognitive treatments for OCD. |
| Lay summary | |
| Ethics approval | Not provided at time of registration |
| Study design | Randomised controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Mental and Behavioural Disorders: Obsessive compulsive disorder (OCD) |
| Participants - inclusion criteria |
1. Referred to Leeds Clinical Psychology services
2. Aged between 16-65 3. Meets diagnostic criteria for OCD 4. OCD is the main presenting problem 5. Checking symptoms are the primary presenting symptom of the disorder |
| Participants - exclusion criteria |
1. The assessment reveals a suicide or self-harm risk
2. Alcohol or drug dependence 3. Learning disability 4. Psychosis |
| Anticipated start date | 01/09/2006 |
| Anticipated end date | 30/06/2007 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 15 as of February 2007 |
| Interventions |
HYPOTHESIS 1
Asking a participant with OCD (checking subtype) to search for a perfect memory will lead to an increase in anxiety, urge to check and belief that the item was not properly checked compared to a condition in which a participant is asked to abandon a memory search. HYPOTHESIS 2 Asking a participant with OCD (checking subtype) to consider a series of Socratic questions about the likelihood that an item was not checked properly will lead to an increase in anxiety, urge to check and belief that the item was not checked properly will lead to an increase in anxiety, urge to check and belief that the item was not checked properly compared to a condition in which the participant uses detached mindfulness. The study will use two ABC single-case series experimental designs. Conditions B and C will be counterbalanced: Half of the participants will be randomly assigned to receive condition B before C; the other participants will receive condition C and then B. This is to ensure that the effects of the experimental manipulations are not due simply to the order in which they were given. STAGE 1: BASELINE (CONDITION A) In the baseline experiment participants will be exposed to their fear provoking stimuli, which may differ between participants. For example, one participant may need to switch off an electrical appliance and walk away without checking whilst another may need to lock a car door. The participant will then spend five minutes doing what they normally do when they have just che4cked something (with the exception of going back to check) and will fill in their visual analogue scales. STAGE 2: EXPERIMENT 1 (CONDITION B) Participants will be given a rationale about the use of memory searching as a technique people sometime use to prevent them from checking. Once the Principal Investigator is confident that the participant understands how to do a memory search, the participant will repeat their exposure to the fear producing stimuli and then return to the research room to engage in a five minute memory search whilst completing the visual analogue scale. STAGE 3: EXPERIMENT 1 (CONDITION C) Participants will be given a rationale which suggests why memory searching may not be useful. The participant will then be asked to think of ways to abandon doing a memory search. Once the Principal Investigator is confident that the participant is able to abandon the memory search, the participant will repeat their exposure to the feared stimuli and then return to the research room to engage in five minutes of deliberately not searching their memory whilst completing the visual analogue scales. EXPERIMENT 2 Experiment 2 will take place approximately one week after the first experimental session. The design of the experiment will be exactly the same as experiment 1 except that it will test hypothesis 2. The rationales will therefore be on the use of Socratic questioning and the use of detached mindfulness. |
| Primary outcome measure(s) | Visual analogue scales used standardly in CBT |
| Secondary outcome measure(s) |
1. MINI International Neuropsychiatric Interview
2. Yale-Brown Obsessive Compulsive Scale 3. Padua Inventory 4. Maudsley Obsessive-Compulsive Inventory 5. Beck Depression Inventory - 1st and 2nd editions |
| Sources of funding |
South West Yorkshire Mental Health NHS Trust
NHS R&D Support Funding |
| Trial website | |
| Publications | |
| Contact name | Miss Stacey Danks |
| Address |
Academic Unit of Psychiatry & Behavioural Sciences
University of Leeds 15 Hyde Terrace |
| City/town | Leeds |
| Zip/Postcode | LS2 9LT |
| Country | United Kingdom |
| Tel | +44 0114 268 5525 |
| Fax | +44 |
| Sponsor | Record Provided by the NHSTCT Register - 2007 Update - Department of Health |
| Address | The Department of Health, Richmond House, 79 Whitehall |
| City/town | London |
| Zip/Postcode | SW1A 2NL |
| Country | United Kingdom |
| Tel | +44 (0)20 7307 2622 |
| Fax | +44 |
| dhmail@doh.gsi.org.uk | |
| Sponsor website: | http://www.dh.gov.uk/Home/fs/en |
| Date applied | 28/09/2007 |
| Last edited | 07/07/2009 |
| Date ISRCTN assigned | 28/09/2007 |
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