Condition category
Mental and Behavioural Disorders
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Dr Christopher Williams


Contact details

Psychological Medicine
Gartnavel Royal Hospital
1055 Great Western Road
G63 9SJ
United Kingdom
+44 (0)141 2113912

Additional identifiers

EudraCT number number

Protocol/serial number

04 AMO6

Study information

Scientific title


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


Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type


Patient information sheet


Depressive symptoms


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



Not Specified

Drug names

Primary outcome measure

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


Overall trial end date


Reason abandoned (if study stopped)


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


Age group




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


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Psychological Medicine
G63 9SJ
United Kingdom

Sponsor information


NHS Greater Glasgow (UK)

Sponsor details

Research Manager
Research and Development Directorate
Gartnavel Royal Hospital
1055 Great Western Road
G12 0XH
United Kingdom
+44 (0)141 211 3661

Sponsor type




Funder type


Funder name

Chief Scientists Office Scottish Executive Health Department (UK) (ref: CZH/4/61)

Alternative name(s)

Funding Body Type

Funding Body Subtype


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

1. 2013 results in

Publication citations

  1. 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.

Additional files

Editorial Notes