Condition category
Mental and Behavioural Disorders
Date applied
19/08/2008
Date assigned
26/09/2008
Last edited
05/04/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Christopher Williams

ORCID ID

Contact details

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

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 measures

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

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

http://www.nhsgg.org.uk

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes