# Abstract

 

## Background Little information is available about whether the use of self-assessment instruments in primary care affects depression course and outcome. The purpose was to evaluate whether using a depression self-rating scale in recurrent person-centred GP consultations affected depression severity, quality of life, medication use, and sick leave frequency. 

## Methods Patients in the intervention group met their GP regularly at least 4 times during the 3 months intervention. In addition to treatment as usual (TAU), patients completed a self-assessment instrument (Montgomery-Asberg Depression Rating Scale) on each occasion, and then GPs used the completed instrument as the basis for a person-centred discussion of changes in depression symptoms. The control group received TAU. Frequency of visits in the TAU arm was the result of the GPs' and patients' joint assessments of care need in each case. Depression severity was measured with Beck Depression Inventory-II (BDI-II), quality of life with EQ-5D, and psychological well-being with the General Health Questionnaire-12 (GHQ-12). Data on sick leave, antidepressant and sedatives use, and care contacts were collected from electronic patient records. All variables were measured at baseline and 3, 6, and 12 months. Mean intra-individual changes were compared between the intervention and TAU group. 

## Results There were no significant differences between the intervention and control group in depression severity reduction or remission rate, change in quality of life, psychological well-being, sedative prescriptions, or sick leave during the whole 12-month follow-up. However, significantly more patients in the intervention group continued antidepressants until the 6 month follow-up (86/125 vs 78/133, *p* \< 0.05). 

## Conclusions When GPs used a depression self-rating scale in recurrent consultations, patients more often continued antidepressant medication according to guidelines, compared to TAU patients. However, reduction of depressive symptoms, remission rate, quality of life, psychological well-being, sedative use, sick leave, and health care use 4-12 months was not significantly different from the TAU group. These findings suggest that frequent use of depression rating scales in person-centred primary care consultations has no further additional effect on patients' depression or well-being, sick leave, or health care use. 

## Trial registration ClinicalTrials.gov Identifier: [NCT01402206](#). Registered June 27 2011(retrospectively registered). 

## Electronic supplementary material The online version of this article (doi:10.1186/s12875-016-0578-9) contains supplementary material, which is available to authorized users. # Results Of the 91 participating GPs, 45 were randomised into a group that provided the intervention and 46 into a group that provided TAU. The participating GPs enrolled 258 patients, and the flow of the patients through the study is shown in Fig. [1](#) \[[23](#)\]. There was no significant difference in participation rate in the patients in the intervention and control groups at the 3-, 6- or 12-months follow-ups. <figure> <p><img src="" /></p> <figcaption>PRI-SMA-Study (CONSORT Flowchart)</figcaption> </figure> Table [1](#) presents the background characteristics of the study population. No significant differences were found between the participants in the intervention and TAU groups at baseline. ::::table-wrap

::: caption
Baseline characteristics of participants in the PRI-SMA trial
(*n* = 258)
:::

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Characteristics Total Intervention TAU^¤^ *p*
*n* (%) *n* (%) *n* (%)

______________________________________________________________________

Participants 258 125 133

Age (years, mean ) 43.48 44.84 42.19 0.2

men 76 (29.5) 31 (24.8) 45 (33.8)

women 182 (70.5) 94 (75.2) 88 (66.2) 0.1

Marital status

single 118 (45.7) 61 (48.8) 57 (42.9)

married/cohabiting 140 (54.3) 64 (51.2) 76 (57.1)

children \<18 years at home 82 (43.2) 36 (40.4) 46 (45.5) 0.5

Lower educational level 34 (13.2) 17 (13.7) 17 (12.8)

Middle educational level 115 (44.7) 61 (49.2) 54 (40.6)

High educational level 108 (42.0) 46 (37.1) 62 (46.6) 0.3

Employment

working/studying 181 (80.8) 90 (81.1) 91 (80.5)

unemployed/retired 43 (19.2) 21 (18.9) 22 (19.5) 0.9

Born outside the Nordic countries 41 (16) 19 (15.3) 22 (16.7) 0.8

Smoking (yes or sometimes) 75 (29.4) 36 (29.3) 39 (29.5) 0.9

Leisure-time physical activity

never 109 (42.4) 57 (46) 52 (39.1)

at least 4 hrs/week 124 (48.2) 55 (44.4) 69 (51.9)

intensive 24 (9.3) 12 (9.7) 12 (9,0) 0.5

Depression

mild (BDI-II 12-19) 32 (13) 16 (13.6) 16 (12.4)

moderate (BDI-II 20-28) 82 (33.2) 39 (33.1) 43 (33.3)



## high moderate (BDI-II 29-36) 68 (27.5) 35 (29.7) 33 (25.6) 0.9

^¤^*TAU* treatment as usual:::: There was a statistically significant difference between participants and drop-outs during the study concerning age (mean age 44.3 in participants, mean age 37.3 in drop-outs, *p* = 0.02), gender (male 14/62, 22.6%, female 16/166, 9.6%, *p* = 0.034), and ethnicity (born in Sweden 21/194, 10.8%, and born outside Sweden 9/32, 28.1%, *p* = 0.035) Figures [2](#), [3](#), and [4](#) shows depression symptoms (BDI-II), quality of life (EQ-5D), and overall psychological well-being (GHQ-12) in intervention and TAU groups at baseline and 3, 6, and 12 months (boxplots). All patients who participated in the study, both those in the intervention and those in the TAU group, improved in all three variables between baseline and 3 months but there were no significant differences in mean changes (mean of intra-individual ∆) between the groups. Improvements were substantial in both groups; at the 3-month follow-up, nearly half the patients no longer had depression (BDI \<13) (49% in the intervention and 47.3% in the TAU group, *p* = 0.89). We also performed logistic regression analyses. The models showed that at the 12-month follow-up, older age was associated with improved BDI-II score (OR 1.05, CI 1.01-1.99), and a higher level of education was associated with improved EQ-5D score (OR 3.9, CI 1.77-8.73). The factors added to the model (sex, age, education, antidepressant medication, and participation in the intervention or TAU group) explained the same amount of variation in both the intervention and TAU groups. Thus, the difference between the groups remained non-significant (data not shown). No adverse events were reported from intervention or TAU group. <figure> <p><img src="" /></p> <figcaption>Depression severity (BDI-II values) in the intervention and TAU groups. Boxplots for baseline, 3-months follow up, 6-months follow up, and 12-months follow up. The outcome variable is presented as box plot with medians, minimum and maximum values and lower and upper quartiles. Y-axis: BDI-II, X-axis: time 0, 3, 6, 12 months. Outliers (<em>circle</em>) are cases with values between 1.5 and 3 times the interquartile range (5 cases with BDI-II ≥50 in patients with difficulties in Swedish language, where complementary diagnostic procedure by the GP ended up on medium depressive disorder)</figcaption> </figure> <figure> <p><img src="" /></p> <figcaption>Quality of life (EQ-5D values) in the intervention and TAU groups. Boxplots for baseline, 3-months follow up, 6-months follow up, and 12-months follow up. The outcome variable is presented as box plot with medians, minimum and maximum values and lower and upper quartiles. Y-axis: EQ-5D, X-axis: time 0, 3, 6, 12 months. Outliers (<em>circle</em>) are cases with values between 1.5 and 3 times the interquartile range, extremes (<em>star</em>) are cases with values more than 3 times the interquartile range</figcaption> </figure> <figure> <p><img src="" /></p> <figcaption>Overall psychological well-being (GHQ-12 values) in the intervention and TAU groups. Boxplots for baseline, 3-months follow up, 6-months follow up, and 12-months follow up. The outcome variable is presented as box plot with medians, minimum and maximum values and lower and upper quartiles. Y-axis: GHQ-12, X-axis: time 0, 3, 6, 12 months. Outliers (<em>circle</em>) are cases with values between 1.5 and 3 times the interquartile range</figcaption> </figure> Table [2](#) shows differences between the intervention and TAU groups in the percent of patients who had prescriptions for antidepressants and sedatives. At baseline, 22% of patients in the intervention group and 32% of patients in the TAU group were on maintenance antidepressant medication. After 3 months, the proportion of patients with prescriptions for antidepressant medication was 72% in both the intervention and the TAU group. At the 6-month follow-up, the proportion of patients taking antidepressants had dropped to 69% in the intervention group and 59% in the TAU group (p = 0.007). At the 12-month follow-up, there were no significant differences in the percent of patients who had prescriptions for antidepressants or sedatives in the intervention and TAU groups (Table [2](#)). ::::table-wrap
::: caption
Number and percent of patients who had prescriptions for antidepressants
and sedatives and stated medication at baseline and 3-, 6-, and
12-months follow up, respectively, in the intervention and TAU groups
:::

```
                        Baseline   3 months follow-up   6 months follow-up   12 months follow-up                           
```

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*n* (%) *n* (%) *n* (% ) *n* (%)\
Antidepressants\
Intervention (n = 125) 27 (22) 90 (72) 86 (69)\*\* 74 (59)
TAU (n = 133) 43 (32) 96 (72) 78 (59) 77 (58)
Sedatives\
Intervention 26 (21) 64 (51) 53 (42) 52 (42)
TAU^¤^ 32 (24) 73 (55) 56 (42) 51 (38)

^¤^*TAU* treatment as usual

\*\*Significantly higher proportion of patients in intervention group
still on antidepressants after 6 months, *p* = 0.007:::: Table [3](#) shows the mean number of days of sick leave by patient group. There were no significant differences in the percentage of patients on sick leave in the intervention and TAU groups between baseline and 3 months, or 4 -12 months, or during the entire study period. The mean total duration of sick leave (days) was not significantly different between the intervention and TAU groups (Table [3](#)). ::::table-wrap
::: caption
Number and percent of individuals on sick leave, mean days of sick
leave, and p-values for difference in mean days of sick leave between
participants in intervention and TAU groups, based on information
obtained from electronic patient records
:::

```
                  Intervention                                TAU                                                              
```

______________________________________________________________________

*n* (%) Mean days of sick leave SD *n* (%) Mean days of sick leave SD *P* for difference mean days\
0-3 months 31(25) 63.1 29.8 48 (36) 55.8 27.7 0.221
4-12 months 35(28) 100.8 87.3 47(35) 102.7 85 0.922
Total 0-12 months 49(39) 124.8 102.5 64 (48) 123.3 85.0 0.942:::: 

## Health care use Mean number of visits at the PHCC, including visits to GP, nurse, psychologist/therapist and total visits to PHCC, was compared between intervention and TAU groups. All information was obtained from EPRs (Table [4](#)). We also compared the total number of visits. There were no significant differences between the intervention and TAU groups regarding these outcomes, during the total 12-month follow-up period. However, during the 0-3 month period, the TAU group made significantly more visits to psychologists/psychotherapists than the intervention group and the intervention group made significantly more total visits to the PHCC than the TAU group. ::::table-wrap
::: caption
Number of patients' contacts with GPs, nurses, and psychologists between
baseline to 3 months, and 4 to12 months for intervention and TAU groups,
based on information obtained from electronic patient records
:::

______________________________________________________________________

Profession Type of contact Intervention 0-3 months m (SD) TAU 0-3 months m (SD) *p*
GP  visit  3.44 (1.214)  2.59 (1.354) 0.066
Nurse  visit  0.32 (0.829)  0.32 (0.875) 0.878
Psychologist/Therapist  visit  0.40 (1.320)  0.89 (1.776) **0. 0001**
Total visits to PHCC  visit  4.16 (2.398)  3.81 (2.692) **0.006**
Intervention 4-12 months m (SD) TAU 4-12 months m (SD) *p*
GP  visit  2. 54 (2.337)  2.38 (2.595) 0.301
Nurse  visit  0. 68 (1.484)  0.62 (1.551) 0.581
Psychologist/Therapist  visit  0. 90 (2.504)  0.83 (1.908) 0.401
Total visits to PHCC  visit  4. 11 (4.586)  3.83 (4.403) 0.619
Intervention total 0-12 months m (SD) TAU total 0-12 months m (SD) *p*
GP  visit  8.26 (5.842)  7.64 (5.976) 0.304
Nurse  visit  0.99 (1.978)  0.94 (2.088) 0.967
Psychologist/Therapist  visit  1.30 (3.129)  1.73 (3.222) 0.167
Total visits to PHCC  visit  8.26 (5.842)  7.64 (5.976) 0.812

______________________________________________________________________

Bold numeral indicates statistically significant *p*-value::::


Extracted trial result:
Outcome: sedative prescriptions (binary)
Intervention: person-centred general practitioners (GP) consultations
Comparator: treatment as usual (TAU)
Intervention events: 52
Intervention group size: 125
Comparator events: 51
Comparator group size: 133
Notes: Data from 12 months follow up (final timepoint)