Background
Methods
Study design
Randomisation of clusters
Eligibility criteria for clusters and participants
Setting
Patient sample
Interventions
Control group and intervention group
Intervention group only
Outcomes
Clinical outcomes on practice level
Clinical outcomes on patient level
Sample size
Statistical methods
Results
Participant flow and numbers analysed
Characteristics at baseline for clusters and individuals
Variables | Intervention group | Control group | pvalue |
---|---|---|---|
Practices | n= 12 | n= 11 | |
Practice type (%) | 0.387 | ||
Solo | 26.1 | 17.4 | |
Group | 60.9 | 78.3 | |
Health centre | 13.0 | 4.4 | |
Mean (SD) number of GPs in the practice | 4.1 (2.9) | 4.3 (2.4) | 0.825 |
Disciplines working in the practice (%) | |||
Practice assistants | 100 | 100 | 1.000 |
Practice nurses: somatic health services | 95.7 | 100 | 0.312 |
Practice nurses: mental health services | 65.2 | 39.1 | 0.007* |
Physician assistants | 0 | 13.0 | 0.073 |
Psychologists | 0 | 4.4 | 0.312 |
Social workers | 13.0 | 0 | 0.073 |
Physiotherapists | 13.0 | 4.4 | 0.295 |
Othersa | 21.7 | 39.1 | 0.200 |
Mean (SD) number of patients per practice | 5,476.3 (4,589.8) | 5,393.5 (3,391.4) | 0.945 |
Variables | Intervention group | Control group | pvalue |
---|---|---|---|
General practitioners | n= 23 | n= 23 | |
Demographic characteristics | |||
Mean (SD) age (years) | 49.5 (9.6) | 47.7 (9.1) | 0.511 |
Male (%) | 65.2 | 43.5 | 0.139 |
Clinical experience, mean no. of years (SD) | 18.4 (10.2) | 16.4 (9.3) | 0.500 |
Employment status (% ≥0.5 FTE) | 95.7 | 100 | 0.312 |
Trainer status (% yes) | 60.9 | 34.8 | 0.077 |
Interest and attitudes towards depressive and anxiety disorders | |||
Special interest in patients with anxiety and depressive disorders (% yes) | 47.8 | 52.2 | 0.768 |
DAQ mean score (SD) | |||
Treatment attitudes | 42.9 (5.6) | 45.8 (8.3) | 0.173 |
Professional unease | 45.4 (8.2) | 44.5 (7.4) | 0.708 |
Depression malleability | 38.4 (10.8) | 41.8 (11.1) | 0.302 |
Depression identification | 47.6 (8.8) | 45.7 (13.1) | 0.560 |
REASONa mean score (SD) | |||
Professional comfort with and competence in care of mental health problems | 3.1 (0.4) | 3.2 (0.5) | 0.432 |
GPs’ concerns about problems with the health care system for treatment of anxiety and depression | 4.5 (0.8) | 4.3 (0.8) | 0.641 |
Mean (SD) number of hours professional training on depression last year | 2.8 (2.2) | 3.4 (2.1) | 0.408 |
Mean (SD) number of hours professional training on anxiety last year | 2.0 (1.5) | 2.5 (1.9) | 0.290 |
Barriers to provision of health careb (% score 4, 5 or 6) | |||
Perceived time limitations | 65.2 | 60.9 | 0.760 |
Perceived lack of knowledge and skills for the recognition of anxiety and depressive disorders | 13.0 | 13.0 | 1.000 |
Perceived lack of knowledge and skills for treatment of anxiety and depressive disorders | 8.7 | 17.4 | 0.381 |
Barriers to implementation of guidelinesc | |||
Barriers for implementation of depression and anxiety guidelines, mean score (SD) | 34.0 (4.3) | 33.8 (4.0) | 0.859 |
Collaboration with professionals in mental health services (% yes) | |||
Mental health nurse in primary care | 56.5 | 59.1 | 0.862 |
Primary care psychologist | 13.0 | 21.7 | 0.437 |
Social workers | 21.7 | 43.5 | 0.116 |
Specialist mental health worker | 4.4 | 9.1 | 0.524 |
Levels of burnout (UBOS-C, %) | |||
Emotional exhaustion | 0.038* | ||
Low level | 39.1 | 69.6 | |
Moderate level | 61 | 30 | |
High level | - | - | |
Depersonalisation | 0.361 | ||
Low level | 17.4 | 21.7 | |
Moderate level | 65.2 | 73.9 | |
High level | 17.4 | 4.4 | |
Personal accomplishment | 0.741 | ||
Low level | 17.4 | 26.1 | |
Moderate level | 47.8 | 39.1 | |
High level | 34.8 | 34.8 |
Variables | Intervention group | Control group | pvalue |
---|---|---|---|
Patients | n= 198b | n= 246c | |
Sociodemographic characteristics | |||
Mean (SD) age (years) | 53.4 (15.6) | 55.0 (16) | 0.294 |
Female | 128 (64.7) | 179 (72.8) | 0.066 |
Born in the Netherlands | 185 (95.4), n = 194 | 233 (95.5), n = 244 | 0.948 |
Married or living together | 133 (68.6), n = 194 | 161 (65.7), n = 245 | 0.529 |
In paid employment | 77 (42.3), n = 182 | 83 (34.7), n = 239 | 0.112 |
Level of education | n = 196 | n = 244 | 0.647 |
Low | 102 (52.0) | 123 (50.4) | |
Medium | 48 (24.5) | 69 (28.3) | |
High | 46 (23.5) | 52 (21.3) | |
Clinical characteristics | |||
Number of chronic medical conditionsa (range: 0–28), mean (SD) | 3.1 (2.1) | 3.0 (2.2) | 0.723 |
4DSQ distress score (range: 0–32), mean (SD) | 12.4 (8.1), n = 193 | 11.9 (7.1), n = 240 | 0.431 |
4DSQ depression score (range: 0–12), mean (SD) | 1.8 (2.8), n = 194 | 1.6 (2.7), n = 239 | 0.480 |
4DSQ anxiety score (range: 0–24), mean (SD) | 3.2 (4.0), n = 194 | 2.8 (3.5), n = 238 | 0.273 |
4DSQ somatisation score (range: 0–32), mean (SD) | 8.5 (5.9), n = 186 | 8.3 (5.9), n = 228 | 0.760 |
Primary outcome measure
Outcome variable | Odds ratio | 95% confidence interval | Test statistics andpvalue | Estimated proportion in control group | Estimated proportion in intervention group |
---|---|---|---|---|---|
Recognition (primary outcome) | 1.60* | (1.01, 2.53) | z = 1.99, p = 0.047 | 0.31 | 0.42 |
Number of consultations | 1.78* | (1.14, 2.78) | z = 2.52, p = 0.012 | 0.57a | 1.01a |
Prescribing antidepressants | 1.07 | (0.52, 2.19) | z = 0.19, p = 0.849 | 0.12 | 0.13 |
Referral to specialist mental health services | 1.62 | (0.72, 3.64) | z = 1.16, p = 0.247 | 0.05 | 0.08 |
Secondary outcome measures
Group | Baseline | 3 months | 6 months | ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Mean | 95% CI | Mean | 95% CI | ES | pvalue | Mean | 95% CI | ES | pvalue | ||
Distress | Intervention | 12.37 | (11.08, 13.66) | 11.16 | (9.77, 12.56) | −0.0 | 0.912 | 10.49 | (9.10, 11.87) | −0.1 | 0.235 |
Control | 11.86 | (10.63, 13.09) | 10.72 | (9.48, 11.96) | 10.76 | (9.50, 12.01) | |||||
Depression | Intervention | 1.80 | (1.40, 2.21) | 1.27 | (0.85, 1.69) | −0.2* | 0.027 | 1.48 | (1.04, 1.91) | −0.1 | 0.445 |
Control | 1.58 | (1.20, 1.97) | 1.52 | (1.14, 1.91) | 1.42 | (1.03, 1.81) | |||||
Anxiety | Intervention | 3.14 | (2.51, 3.78) | 2.65 | (2.01, 3.30) | −0.0 | 0.847 | 2.38 | (1.73, 3.03) | −0.1 | 0.141 |
Control | 2.77 | (2.15, 3.40) | 2.33 | (1.71, 2.96) | 2.40 | (1.78, 3.03) | |||||
Somatisation | Intervention | 8.51 | (7.61, 9.41) | 8.58 | (7.65, 9.52) | +0.1 | 0.284 | 8.74 | (7.78, 9.69) | −0.1 | 0.065 |
Control | 8.25 | (7.41, 9.09) | 7.85 | (7.00, 8.70) | 7.61 | (6.75, 8.48) | |||||
WHODAS II | Intervention | 25.82 | (23.59, 28.06) | 24.32 | (22.01, 26.63) | +0.1 | 0.245 | 21.41 | (19.07, 23.75) | −0.1 | 0.293 |
Control | 23.57 | (21.57, 25.57) | 20.68 | (18.65, 22.71) | 20.39 | (18.36, 22.42) |
Group | Baseline | 3 months | 6 months | ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Mean | 95% CI | Mean | 95% CI | ES | pvalue | Mean | 95% CI | ES | pvalue | ||
Accessibility of care | Intervention | 3.68 | (3.45, 3.92) | 3.61 | (3.35, 3.87) | +0.2 | 0.263 | 3.72 | (3.44, 4.00) | +0.4* | 0.038 |
Control | 3.49 | (3.25, 3.73) | 3.25 | (2.98, 3.51) | 3.19 | (2.92, 3.46) | |||||
Emotional support | Intervention | 3.04 | (2.86, 3.22) | 3.05 | (2.84, 3.25) | +0.2 | 0.341 | 3.21 | (2.99, 3.44) | +0.3 | 0.143 |
Control | 3.10 | (2.93, 3.27) | 2.96 | (2.76, 3.16) | 3.04 | (2.83, 3.24) | |||||
Patient-centred care | Intervention. | 3.29 | (3.14, 3.44) | 3.21 | (3.04, 3.38) | +0.2 | 0.294 | 3.31 | (3.12, 3.50) | +0.1 | 0.642 |
Control | 3.28 | (3.14, 3.42) | 3.07 | (2.91, 3.23) | 3.23 | (3.07, 3.40) | |||||
Quality of care | Intervention | 2.84 | (2.66, 3.02) | 2.85 | (2.64, 3.06) | +0.1 | 0.599 | 3.03 | (2.81, 3.26) | +0.1 | 0.525 |
Control | 2.86 | (2.68, 3.04) | 2.80 | (2.60, 3.00) | 2.96 | (2.75, 3.16) | |||||
Information and advice | Intervention | 3.21 | (3.03, 3.38) | 3.12 | (2.92, 3.32) | +0.0 | 0.842 | 3.48 | (3.26, 3.70) | +0.5* | 0.013 |
Control | 3.29 | (3.12, 3.45) | 3.17 | (2.98, 3.37) | 3.18 | (2.98, 3.38) | |||||
Self-help advice | Intervention | 2.77 | (2.57, 2.97) | 2.85 | (2.62, 3.09) | +0.1 | 0.649 | 2.99 | (2.73, 3.24) | +0.2 | 0.311 |
Control | 2.86 | (2.67, 3.06) | 2.87 | (2.64, 3.09) | 2.89 | (2.66, 3.12) |