An evaluation of the effectiveness of structured Cognitive Behaviour Therapy (CBT) self-help materials delivered by a self-help support worker within primary care
| ISRCTN | ISRCTN13475030 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13475030 |
| Secondary identifying numbers | 04 AMO6 |
- Submission date
- 30/08/2005
- Registration date
- 09/09/2005
- Last edited
- 21/01/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Christopher Williams
Scientific
Scientific
Psychological Medicine
Gartnavel Royal Hospital
1055 Great Western Road
Glasgow
G63 9SJ
United Kingdom
| Phone | +44 (0)141 2113912 |
|---|---|
| chris.williams@clinmed.gla.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/04/2004 |
| Completion date | 30/06/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 100 evaluable patients in each arm i.e. 200 evaluable patients |
| Key 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. |
| Key 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]) |
| Date of first enrolment | 01/04/2004 |
| Date of final enrolment | 30/06/2007 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
Psychological Medicine
Glasgow
G63 9SJ
United Kingdom
G63 9SJ
United Kingdom
Sponsor information
NHS Greater Glasgow (UK)
Government
Government
Research Manager
Research and Development Directorate
Gartnavel Royal Hospital
1055 Great Western Road
Glasgow
G12 0XH
United Kingdom
| Phone | +44 (0)141 211 3661 |
|---|---|
| brian.rae@gartnavel.glacomen.scot.nhs.uk | |
"ROR" |
https://ror.org/05kdz4d87 |
Funders
Funder type
Government
Chief Scientists Office Scottish Executive Health Department (UK) (ref: CZH/4/61)
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2013 | Yes | No |
