A pilot trial of computerised cognitive behaviour therapy for depression in adolescents
| ISRCTN | ISRCTN31219579 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN31219579 |
| Secondary identifying numbers | 9518 |
- Submission date
- 29/09/2011
- Registration date
- 29/09/2011
- Last edited
- 01/02/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Each year around 2% of young people are affected by low mood or depression. Some worry about giving teenagers drug treatments in these situations as they question whether or not they work and they worry about their possible side effects. This study aims to find out whether a treatment called 'cognitive behaviour therapy' helps young people with a low mood when it is delivered on a computer (and not by a person).
Who can participate?
Both male and female adolescents aged between 12 and 18 and suffering from low mood/ depression will be asked if they would like to take part.
What does the study involve?
Participants will be randomly allocated to one of two groups. In one group participants will be asked to complete a computer package, 'Stressbusters', in the other they will be asked to look at websites about low mood. Both groups will involve eight 45 minute sessions on a computer. Both before and after the computer sessions, participants will be asked to complete questionnaires about how they are feeling. Some will also be invited to take part in an interview.
What are the possible benefits and risks of participating?
It is hoped that by taking part in the trial adolescents with low mood or depression will notice an improvement in their symptoms. In addition all adolescents will receive a £10 gift voucher at 4 months following the trial to thank them for taking part.
Where is the study run from?
The study is being run at Lime Trees Child, Adolescent and Family Unit in York and within a local school. It is hoped that this will expand to more schools and GP practices as the trial continues.
When is the study starting and how long is it expected to run for?
The study officially started in June 2011 and will last 3 years. We will be recruiting for 2 years, up until the end of July 2013.
Who is funding the study?
The research has been organised by Lime Trees Child, Adolescent and Family Unit at York which is part of the NHS. It has been funded by a special research grant.
Who is the main contact?
Lucy Tindall
lucy.tindall@nyypct.nhs.uk
Contact information
Scientific
NHS North Yorkshire and York
31 Shipton Road
York
YO30 5RE
United Kingdom
| Phone | +44 (0)1904 721 219 |
|---|---|
| Lucy.Tindall@nyypct.nhs.uk |
Study information
| Study design | Randomised; Interventional; Design type: Treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | A feasibility study and pilot trial of computerised cognitive behaviour therapy for depression in adolescents |
| Study objectives | This study is a pilot and feasibility trial to establish the acceptability of cCBT treatment for adolescent depression. |
| Ethics approval(s) | Leeds (West) Research Ethics committee, 08/02/2011, ref: 10/H1307/137 |
| Health condition(s) or problem(s) studied | Depression |
| Intervention | Stressbusters, computerised CBT programme aimed at adolescents with low mood/depression. The intervention comprises 8, 45 minute weekly sessions; Follow Up Length: 0 month(s); Study Entry : Single Randomisation only Young people between the ages of 12 and 18 with low mood (as determined by a score of 20 or above on the MFQ) will be randomised to either a cCBT programme 'Stressbusters' or an attention control - spending the equivalent time viewing current internet self help websites. At baseline all consenting participants will be asked to complete the Spence Anxiety Scale, the Beck Depression Inventory, a Risk Factor Schedule and a life story epidemiology proforma. At both four and twelve months follow up each participant will complete the Spence, Beck and MFQ again. Qualitative information about recruitment, acceptability and satisfaction with the cCBT programme will also be collected through interviews with participants. Given the affinity young people have with information technology this trial questions whether young people could be treated effectively and more widely using computer administered CBT. Thus this study will produce important research evidence which will inform the care of young people in the UK NHS. |
| Intervention type | Other |
| Primary outcome measure | Mood and Feelings Questionnaire; Timepoint(s): 4 months & 12 months follow up |
| Secondary outcome measures | 1. The Beck Depression Inventory; Timepoint(s): 4 months & 12 months follow up 2. The Spence Anxiety Scale; Timepoint(s): 4 months & 12 months follow up |
| Overall study start date | 01/09/2011 |
| Completion date | 31/08/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 12 Years |
| Upper age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 96; UK Sample Size: 96 |
| Key inclusion criteria | 1. Children and young people aged 12-18 years with low mood as measured by a MFQ score of 20 or above. 2. We will also include participants with either co-morbid physical illness or co-morbid non-psychotic functional disorders, such as anxiety 3. Target Gender: Male & Female |
| Key exclusion criteria | 1. We will exclude participants who are seeking to end their life 2. Suffering psychotic symptoms or depressed in the post-natal period 3. Cases of psychotic depression 4. Participants with previous depression or previous treatment with anti-depressants or experience of cognitive therapy will not be excluded. |
| Date of first enrolment | 01/09/2011 |
| Date of final enrolment | 31/07/2013 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
YO30 5RE
United Kingdom
Sponsor information
Hospital/treatment centre
Learning and Research Centre
Wigginton Road
York
YO31 8HE
England
United Kingdom
| Phone | +44 (0)1904 631 313 |
|---|---|
| enquiries@york.nhs.uk | |
| Website | http://www.york.nhs.uk/ |
"ROR" |
https://ror.org/027e4g787 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 31/10/2014 | Yes | No | |
| Results article | results | 27/01/2017 | Yes | No |
Editorial Notes
01/02/2017: Publication reference added.
