Condition category
Mental and Behavioural Disorders
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
25/04/2014
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

Mr Darren Spooner

ORCID ID

Contact details

Clinical Psychologist
Norfolk Mental Health Care NHS Trust
Kingfisher House
Wensum Meadows
Hellesdon Hospital
Norwich
NR6 5NB
United Kingdom
+44 01603 421685

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0546117071

Study information

Scientific title

Acronym

Study hypothesis

1. That the clinical effectiveness of computer based interactive behavioural self help is equal to the clinical effectiveness of a traditional cognitive behavioural self help manual for adults suffering from mild to moderate depressive illness or anxiety.
2. That traditional cognitive behavioural self help manuals are more cost effective than computer based interactive cognitive behavioural self help for adults suffering from mild to moderate depressive illness or anxiety.
3. That both computer based interactive cognitive behavioural self help and traditional cognitive behavioural self help manuals are at least as clinically effective as GP care as usual for adults suffering from mild to moderate depressive illness or anxiety.

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

Not Specified

Patient information sheet

Condition

Mental and Behavioural Disorders: Depression

Intervention

Randomised to one of four conditions:
1. Computer based cognitive behaviour therapy (CBT) self help - immediate start
2. Computer based CBT self help - delayed start (8 weeks)
3. Manual based CBT self help - immediate start
4. Manual based CBT self help - delayed start (8 weeks)

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Conclusion of active treatment phase - 8 weeks of therapy.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

10/08/2002

Overall trial end date

10/02/2003

Reason abandoned

Eligibility

Participant inclusion criteria

200 patients

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

200

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

10/08/2002

Recruitment end date

10/02/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Clinical Psychologist
Norwich
NR6 5NB
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

East Norfolk and Waveney Research Consortium - Norfolk Mental Health Care NHS Trust

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