Effectiveness of a computerised cognitive behavioural therapy programme (Overcoming Depression) for patients suffering from depression as compared to a waiting list control group.

ISRCTN	ISRCTN78427302
DOI	https://doi.org/10.1186/ISRCTN78427302
Protocol serial number	N0573142164
Sponsor	Department of Health
Funder	Newcastle, North Tyneside and Northumberland Mental Health NHS Trust (UK), NHS R&D Support Funding

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr Robert Dudley
Scientific

Newcastle Cognitive & Behavioural Therapies Centre
Plummer Court
Carliol Place
Newcastle upon Tyne
NE1 6UR
United Kingdom

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Will people receiving Computerised Cognitive Behavioural Therapy (CCBT) show reductions in depressive and anxious symptoms in comparison to those receiving no intervention?
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Mental and Behavioural Disorders: Depression
Intervention	Computerised Cognitive Behavioural Therapy (CCBT) vs no intervention
Intervention type	Other
Primary outcome measure(s)	Beck Depression Inventory (BDI); Beck Anxiety Inventory; Clinical Outcomes in Routine Evaluation: Hospital Anxiety and Depression Scale. The BDI is the most frequently used measure for considering the effect size. Drawing on similar previous trials we could expect a reduction in BDI scores of approximately 10 points.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	30/06/2004

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	40
Key inclusion criteria	Male and female adult out patients who have been referred for specialist cognitive behavioural therapy for treatment of depression. Participants will have: 1. Primary diagnosis of depression disorder or anxiety. 2. No change in medication for the previous 12 weeks. 3. Willingness to try a trial of CCBT. 4. No evidence of severe depression or suicidal intent. 5. No evidence of current substance abuse. 6. No evidence of organic impairment. 7. Agreement of RMO for participation.
Key exclusion criteria	1. Patients with organic disorders 2. Patients with personality disorder 3. Patients who can not comprehend English
Date of first enrolment	01/06/2003
Date of final enrolment	30/06/2004

Newcastle Cognitive & Behavioural Therapies Centre

Newcastle upon Tyne
NE1 6UR
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan