Condition category
Mental and Behavioural Disorders
Date applied
25/08/2005
Date assigned
13/09/2005
Last edited
13/08/2007
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

Prof Karina Lovell

ORCID ID

Contact details

School of Nursing
Midwifery & Social Work
The University of Manchester
Oxford Road
Manchester
M13 9PL
United Kingdom

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

  1. 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.

Additional files

Editorial Notes