Condition category
Mental and Behavioural Disorders
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
01/09/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes