DClinPsy: Maladaptive cognitive processes during exposure in people with OCD (checking subtype)
ISRCTN | ISRCTN60061491 |
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DOI | https://doi.org/10.1186/ISRCTN60061491 |
Secondary identifying numbers | N0266190334 |
- Submission date
- 28/09/2007
- Registration date
- 28/09/2007
- Last edited
- 01/09/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Miss Stacey Danks
Scientific
Scientific
Academic Unit of Psychiatry & Behavioural Sciences
University of Leeds
15 Hyde Terrace
Leeds
LS2 9LT
United Kingdom
Phone | +44 (0)114 268 5525 |
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abc@email.com |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
Scientific title | DClinPsy: Maladaptive cognitive processes during exposure in people with OCD (checking subtype) |
Study objectives | 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. |
Ethics approval(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | Mental and Behavioural Disorders: Obsessive compulsive disorder (OCD) |
Intervention | 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 checked 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. |
Intervention type | Other |
Primary outcome measure | Visual analogue scales used standardly in CBT |
Secondary outcome measures | 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 |
Overall study start date | 01/09/2006 |
Completion date | 30/06/2007 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 15 as of February 2007 |
Key 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 |
Key exclusion criteria | 1. The assessment reveals a suicide or self-harm risk 2. Alcohol or drug dependence 3. Learning disability 4. Psychosis |
Date of first enrolment | 01/09/2006 |
Date of final enrolment | 30/06/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University of Leeds
Leeds
LS2 9LT
United Kingdom
LS2 9LT
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Phone | +44 (0)20 7307 2622 |
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dhmail@doh.gsi.org.uk | |
Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
South West Yorkshire Mental Health NHS Trust
No information available
NHS R&D Support Funding
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |