Depressive symptoms Mental and Behavioural Disorders Depressive episode
Conditions
Interventions
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 treatmen
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.
Sponsors
NHS Greater Glasgow (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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])
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
United Kingdom
Outcome results
None listed