Contact information
Type
Scientific
Primary contact
Miss Stacey Danks
ORCID ID
Contact details
Academic Unit of Psychiatry & Behavioural Sciences
University of Leeds
15 Hyde Terrace
Leeds
LS2 9LT
United Kingdom
+44 (0)114 268 5525
abc@email.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0266190334
Study information
Scientific title
DClinPsy: Maladaptive cognitive processes during exposure in people with OCD (checking subtype)
Acronym
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.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
01/09/2006
Overall trial end date
30/06/2007
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
15 as of February 2007
Participant exclusion criteria
1. The assessment reveals a suicide or self-harm risk
2. Alcohol or drug dependence
3. Learning disability
4. Psychosis
Recruitment start date
01/09/2006
Recruitment end date
30/06/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Leeds
Leeds
LS2 9LT
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
South West Yorkshire Mental Health NHS Trust
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
NHS R&D Support Funding
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary