Condition category
Mental and Behavioural Disorders
Date applied
13/08/2004
Date assigned
08/11/2004
Last edited
14/09/2009
Prospective/Retrospective
Prospectively 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

Dr David Kessler

ORCID ID

Contact details

Division of Primary Care
University of Bristol
Cotham House
Cotham Hill
Bristol
BS6 6JL
United Kingdom
david.kessler@bristol.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

To evaluate the clinical and cost effectiveness of Internet based cognitive behavioural therapy (webCBT) for depression compared to a waiting list control in primary care. A qualitative study will be done as part of the trial to assess the acceptability of the intervention to patients and health care providers.

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

Other

Trial type

Treatment

Patient information sheet

Condition

Depression

Intervention

Intervention: Up to eight one hour sessions of cognitive behavioural therapy (CBT) delivered online by a qualified psychologist.

Control: The control group will be on a waiting list for CBT of 8 months and will receive 'usual care' from their GP. This may include pharmacological treatment but will not include psychotherapy.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The Beck depression inventory score at 2 months adjusted for baseline.

Secondary outcome measures

EQ5D and SF-12 at 8 months

Overall trial start date

01/10/2005

Overall trial end date

30/09/2008

Reason abandoned

Eligibility

Participant inclusion criteria

Patients with GP diagnosed depression in primary care. Diagnosis must be confirmed by standardised psychological measure.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

470

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

01/10/2005

Recruitment end date

30/09/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Division of Primary Care
Bristol
BS6 6JL
United Kingdom

Sponsor information

Organisation

University of Bristol (UK)

Sponsor details

Gillian Tallents
Research Governance Manager
Research and Enterprise Development
Senate House
Tyndall Avenue
Bristol
BS8 1TH
United Kingdom
Gillian.Tallents@bristol.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

BUPA Foundation (UK) (ref: 683/G14)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United Kingdom

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

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19700005

Publication citations

  1. Results

    Kessler D, Lewis G, Kaur S, Wiles N, King M, Weich S, Sharp DJ, Araya R, Hollinghurst S, Peters TJ, Therapist-delivered Internet psychotherapy for depression in primary care: a randomised controlled trial., Lancet, 2009, 374, 9690, 628-634, doi: 10.1016/S0140-6736(09)61257-5.

Additional files

Editorial Notes