DClinPsy: Maladaptive cognitive processes during exposure in people with OCD (checking subtype)

ISRCTN ISRCTN60061491
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

Academic Unit of Psychiatry & Behavioural Sciences
University of Leeds
15 Hyde Terrace
Leeds
LS2 9LT
United Kingdom

Phone +44 (0)114 268 5525
Email abc@email.com

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleDClinPsy: Maladaptive cognitive processes during exposure in people with OCD (checking subtype)
Study objectivesThe 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) studiedMental and Behavioural Disorders: Obsessive compulsive disorder (OCD)
InterventionHYPOTHESIS 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 typeOther
Primary outcome measureVisual analogue scales used standardly in CBT
Secondary outcome measures1. 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 date01/09/2006
Completion date30/06/2007

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants15 as of February 2007
Key inclusion criteria1. 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 criteria1. The assessment reveals a suicide or self-harm risk
2. Alcohol or drug dependence
3. Learning disability
4. Psychosis
Date of first enrolment01/09/2006
Date of final enrolment30/06/2007

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

University of Leeds
Leeds
LS2 9LT
United Kingdom

Sponsor information

Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email 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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan