Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Diabetes v.14
Study information
Scientific title
Acronym
Study hypothesis
The self-rating scores for depression will be more improved in the intervention arm than in the treatment as usual (control) arm.
Ethics approval
Glasgow and Clyde Primary Care, Community and Mental Health Ethics Committee. Date of approval: 12/08/2008 (REC No: 08/S0701/65)
Study design
Single-centre, randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Diabetes and depression
Intervention
Trial status amended to 'stopped' as of 05/04/2013 due to notification of lack of staff/resources.
Control arm: Treatment as usual
Intervention arm: Treatment as usual plus computerised cognitive behavioural therapy (CCBT). The CCBT is a self-help intervention supported by mental health practitioners.
Added as of 24/10/2008: The supported self-help intervention will comprise 4 support sessions over 6 weeks, and 6 sessions using an online CCBT package. It is approximated that this will take the participants 8 weeks to complete.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Change in depression as measured by BDI-II, assessed at baseline, Month 4, 5 and 12.
Secondary outcome measures
1. Anxiety state and other depression measures will be carried out using the Hospital Anxiety and Depression Scale (HADS)and PHQ-9 at baseline, Month 4, 5 and 12
2. Social functioning will be measured using the Work and Social Adjustment Scale (WASAS) at baseline, Month 4, 5 and 12
3. Mental health literacy will be measured using a revised questionnaire from previous studies at baseline, Month 4, 5 and 12
4. Acceptability of the trial interventions will be measured using two satisfaction items asking overall satisfaction with the treatment option at Month 4 and 12 (this is in line with other similar studies)
5. Health care usage/costs will be costed using the Client Service Receipt Inventory (modified) and euroquol EQ-5D at baseline, Month 4, 5 and 12
6. Diabetes status: Hb1Ac will be sought using routine clinical data from clinical notes
In addition, a qualitative interview will be carried out in a subset of participants from both arms at 5 months, to collect data for the following aspects of the self-help CCBT:
1. Personal experience of low mood
2. Interaction with support worker
3. First and subsequent experiences of CCBT
4. Outcome of CCBT
Overall trial start date
01/08/2008
Overall trial end date
31/07/2010
Reason abandoned (if study stopped)
Lack of staff/facilities/resources
Eligibility
Participant inclusion criteria
Participants will be recruited from a diabetic clinic, therefore all participants will be diabetic.
Inclusion criteria:
1. Both males and females, aged 18 and above
2. Currently experiencing depression as defined by a score of 10 or greater on the Patient Health Questionnaire 9 (PHQ-9)
3. Able and to use the computerised cognitive behavioural therapy (CCBT) package (have access to computer and broadband internet and an active e-mail address)
4. Willing to use the CCBT self-help package
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
184
Participant exclusion criteria
1. Not fluent in the English language (unable to read/write or communicate)
2. Alcohol intake above 31 and 22 units for men and women, respectively (1.5 times the current recommended maximum drinking levels)
3. Drug dependency defined as using street drugs everyday
4. Those who are actively suicidal, as defined by a score of 2 or more on the Beck Depression Inventory II (BDI-II) suicide item
5. Those who have received access to supported self-help in the last 6 months
6. Involved in other clinical research studies
7. Past or current history of psychosis or bipolar disorder
Recruitment start date
01/08/2008
Recruitment end date
31/07/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Glasgow
Glasgow
G12 0XH
United Kingdom
Sponsor information
Organisation
NHS Greater Glasgow and Clyde (UK)
Sponsor details
Research and Development Directorate
Dalian House
350 St Vincent Street
Glasgow
G3 8YZ
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Glasgow Institute for Psychosocial Interventions (GIPSI), NHS Greater Glasgow and Clyde (UK)
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
Basic results (scientific)
Publication list