Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RDO/28/1/26
Study information
Scientific title
Acronym
Study hypothesis
Exposure therapy and response prevention will yield equivalent clinical outcomes whether delivered by telephone or by face to face therapist contact in the treatment of obsessive-compulsive disorder
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
Not specified
Trial type
Treatment
Patient information sheet
Condition
Obsessive-compulsive disorder (OCD)
Intervention
Exposure therapy and response prevention delivered by either telephone or face to face
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
CBT delivered by telephone shows equivalent clinical outcome as face to face therapy and similar levels of satisfaction were reported.
Secondary outcome measures
Cost-minimisation analysis shows that treatment by telephone is cheaper than face to face CBT. The main cost-driver is treatment time defined by the protocol and, for telephone-administered CBT, this duration was shorter.
Overall trial start date
01/10/2000
Overall trial end date
30/09/2002
Reason abandoned
Eligibility
Participant inclusion criteria
1. Obsessive-compulsive disorder as the main presenting problem
2. Meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for OCD
3. Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score of 16 and over
4. Aged between 16-65
5. Agree to, and give written consent to participate in the study
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
80
Participant exclusion criteria
1. Obsessions without overt compulsions
2. Obsessional slowness
3. Organic brain disease
4. On a stable dose of antidepressants or anxiolytic medication for less than 3 months
5. Past or present psychosis
6. Meet DSM-IV criteria for substance abuse or dependence
7. Currently on more than 10 mg of Diazepam or equivalent daily
8. Severe depression >30 on Beck Depression Inventory (BDI)
9. Suicidal intent
Recruitment start date
01/10/2000
Recruitment end date
30/09/2002
Locations
Countries of recruitment
United Kingdom
Trial participating centre
School of Nursing
Manchester
M13 9PL
United Kingdom
Sponsor information
Organisation
North West Research and Development Support Unit (UK)
Sponsor details
c/o Ms Sue Riley
Institute for Public Health Research & Policy
The University of Salford
4th Floor Humphrey Booth House
Hulme Place
The Crescent
Salford
Manchester
M5 4AO
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
North West Research and Development Support Unit, Salford (Ref: RDO/28/1/26) - regional NHS R&D funding stream
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
Results in:
http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=16935946
Publication citations
-
Results
Lovell K, Cox D, Haddock G, Jones C, Raines D, Garvey R, Roberts C, Hadley S, Telephone administered cognitive behaviour therapy for treatment of obsessive compulsive disorder: randomised controlled non-inferiority trial., BMJ, 2006, 333, 7574, 883, doi: 10.1136/bmj.38940.355602.80.