Contact information
Type
Scientific
Primary contact
Dr Christopher Williams
ORCID ID
Contact details
Psychological Medicine
Gartnavel Royal Hospital
1055 Great Western Road
Glasgow
G63 9SJ
United Kingdom
+44 (0)141 2113912
chris.williams@clinmed.gla.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
04 AMO6
Study information
Scientific title
Acronym
Study hypothesis
1. Patients using the CBT self-help materials will have:
1.1. Improved mood measured on the Beck Depression Inventory (BDI-II)
1.2. Improved social functioning measured on the Clinical Outcome Measure in Routine evaluation - Outcome Measure (CORE-OM)
1.3. Lower health care costs
1.4. Improved knowledge of the causes and treatment of depression compared to the control group receiving treatment as usual
2. Written self-help will be acceptable to both patients and staff within a primary care setting
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Depressive symptoms
Intervention
We are evaluating a structured self-help workbook treatment for mild to moderate depression called Overcoming Depression: A Five Areas Approach. A randomised controlled study design comparing treatment as usual as a control (arm 1); and supported self-help via three 40-minute appointments at week 1, 2 and one month (the '2 + 1' model, Barkham et al, 1996) comprising the second arm of the study.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Comparison between the Beck Depression Inventory -II scores for the two randomised groups (self help plus treatment as usual versus TAU) using a 2 sample 2-sided t-test at 4 months.
Secondary outcome measures
Psychological symptoms, well-being, risk and social functioning (using the CORE-OM scale), and acceptability of the intervention (using the Client Satisfaction Questionnaire- CSQ) compared to treatment as usual. In addition, the health care costs of both arms are being evaluated and the Euroquol (European Quality of Life measure) used to record health status and health-related quality of life change. Secondary analyses will also examine the impact of treatment patient knowledge. Further analyses that adjust the treatment effect for a pre-specified set of baseline covariates thought to be of influence on the treatment effect such as use of antidepressants, other self-help materials, and the chronicity of depression using Normal Linear models, will be considered. The approach by Jacobson et al, (1991) to present change in the group under study at the level of the individual will also be used. Categorical data will be compared between the two groups using chi-squared tests and logistic regression to adjust for covariates.
Overall trial start date
01/04/2004
Overall trial end date
30/06/2007
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients presenting in a primary care/General Practice setting with symptoms of depression
2. Beck Depression Inventory -II score of 14 or more
3. Aged eighteen or above
4. Able to use the materials (i.e. have no visual or reading problems, learning difficulties or dementia)
Any member of the primary care team including GPs, practice or district nurses and health visitors will be able to refer to the study.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100 evaluable patients in each arm i.e. 200 evaluable patients
Participant exclusion criteria
1, Suicidal intent (score of 2 or more on the BDI-II suicidal thoughts item)
2. Impaired concentration and motivation (as measured by a score of 7 or more on the combined BDI II items for energy [item 15], concentration difficulty [item 19] and tiredness [item 20])
Recruitment start date
01/04/2004
Recruitment end date
30/06/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Psychological Medicine
Glasgow
G63 9SJ
United Kingdom
Sponsor information
Organisation
NHS Greater Glasgow (UK)
Sponsor details
Research Manager
Research and Development Directorate
Gartnavel Royal Hospital
1055 Great Western Road
Glasgow
G12 0XH
United Kingdom
+44 (0)141 211 3661
brian.rae@gartnavel.glacomen.scot.nhs.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Chief Scientists Office Scottish Executive Health Department (UK) (ref: CZH/4/61)
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
1. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23326352
Publication citations
-
Results
Williams C, Wilson P, Morrison J, McMahon A, Andrew W, Allan L, McConnachie A, McNeill Y, Tansey L, Guided self-help cognitive behavioural therapy for depression in primary care: a randomised controlled trial., PLoS ONE, 2013, 8, 1, e52735, doi: 10.1371/journal.pone.0052735.