Screening and support for depression in people with diabetes: a randomised controlled study

ISRCTN	ISRCTN93089066
DOI	https://doi.org/10.1186/ISRCTN93089066
Secondary identifying numbers	Diabetes v.14

Submission date: 19/08/2008
Registration date: 26/09/2008
Last edited: 05/04/2013

Recruitment status: Stopped
Overall study status: Stopped
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

Dr Christopher Williams
Scientific

University of Glasgow
Section of Psychological Medicine
Department of Psychological Medicine
1055 Great Western Road
Gartnavel Royal Hospital
Glasgow
G12 0XH
United Kingdom

Study information

Study design	Single-centre, randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study objectives	The self-rating scores for depression will be more improved in the intervention arm than in the treatment as usual (control) arm.
Ethics approval(s)	Glasgow and Clyde Primary Care, Community and Mental Health Ethics Committee. Date of approval: 12/08/2008 (REC No: 08/S0701/65)
Health condition(s) or problem(s) studied	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
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 study start date	01/08/2008
Completion date	31/07/2010
Reason abandoned (if study stopped)	Lack of staff/facilities/resources

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target number of participants	184
Key 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
Key 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
Date of first enrolment	01/08/2008
Date of final enrolment	31/07/2010

Locations

Countries of recruitment

Scotland
United Kingdom

Study participating centre

University of Glasgow

Glasgow
G12 0XH
United Kingdom

Sponsor information

NHS Greater Glasgow and Clyde (UK)
Government

Research and Development Directorate
Dalian House
350 St Vincent Street
Glasgow
G3 8YZ
United Kingdom

Website	http://www.nhsgg.org.uk
"ROR"	https://ror.org/05kdz4d87

Funders

Funder type

Government

Glasgow Institute for Psychosocial Interventions (GIPSI), NHS Greater Glasgow and Clyde (UK)

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