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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

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

Miss Lucy Tindall
Scientific

NHS North Yorkshire and York
31 Shipton Road
York
YO30 5RE
United Kingdom

Phone +44 (0)1904 721 219
Email Lucy.Tindall@nyypct.nhs.uk

Study information

Study designRandomised; Interventional; Design type: Treatment
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleA feasibility study and pilot trial of computerised cognitive behaviour therapy for depression in adolescents
Study objectivesThis 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) studiedDepression
InterventionStressbusters, 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 typeOther
Primary outcome measureMood and Feelings Questionnaire; Timepoint(s): 4 months & 12 months follow up
Secondary outcome measures1. 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 date01/09/2011
Completion date31/08/2014

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit12 Years
Upper age limit18 Years
SexBoth
Target number of participantsPlanned Sample Size: 96; UK Sample Size: 96
Key inclusion criteria1. 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 criteria1. 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 enrolment01/09/2011
Date of final enrolment31/07/2013

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

NHS North Yorkshire and York
York
YO30 5RE
United Kingdom

Sponsor information

York Hospital NHS Trust (UK)
Hospital/treatment centre

Learning and Research Centre
Wigginton Road
York
YO31 8HE
England
United Kingdom

Phone +44 (0)1904 631 313
Email enquiries@york.nhs.uk
Website http://www.york.nhs.uk/
ROR logo "ROR" https://ror.org/027e4g787

Funders

Funder type

Government

NIHR - Research for Patient Benefit (RfPB), ref: PB-PG-0609-19295

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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.