Cognitive-behavioural self-help for depressed and anxious adults; a randomised controlled trial comparing computer based interactive self-help versus a self-help treatment manual
| ISRCTN | ISRCTN32111346 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN32111346 |
| Protocol serial number | N0546117071 |
| Sponsor | Department of Health (UK) |
| Funder | East Norfolk and Waveney Research Consortium - Norfolk Mental Health Care NHS Trust |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 25/04/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
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
Contact information
Mr Darren Spooner
Scientific
Scientific
Clinical Psychologist
Norfolk Mental Health Care NHS Trust
Kingfisher House, Wensum Meadows
Hellesdon Hospital
Norwich
NR6 5NB
United Kingdom
| Phone | +44 01603 421685 |
|---|
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
Conclusion of active treatment phase - 8 weeks of therapy. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 10/02/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target sample size at registration | 200 |
| Key inclusion criteria | 200 patients |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 10/08/2002 |
| Date of final enrolment | 10/02/2003 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Clinical Psychologist
Norwich
NR6 5NB
United Kingdom
NR6 5NB
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
