Lamers 2011.
| Methods | Parallel randomised controlled trial; randomisation ratio 1:1 | |
| Participants |
Inclusion criteria: minor depression or mild to moderate major depression Exclusion criteria: severe major depression or with suicidal risk; treatment with antidepressants for depression, major psychiatric problems (bipolar depression, schizophrenia, alcohol or substance abuse), current psychosocial/psychiatric treatment, serious cognitive problems, on waiting list for nursing home, bedridden, loss of spouse in last 3 months and not being fluent in Dutch Diagnostic criteria: disease‐specific quality of life was operationalised as diabetes‐specific symptom distress assessed with the Diabetes Symptom Checklist – Revised (DSC‐R); emotional distress using the PAID questionnaire; haemoglobin A1c (HbA1c) retrieved from participants' records |
|
| Interventions |
Number of study centres: 89 Treatment before study: — Titration period: no Intervention: cognitive behavioural therapy (CBT) with self‐management principles. Its aim was to educate people to take responsibility for the daily management of their own illness and its consequences. The intervention consists of 5 steps. In the first step, the nurse explores the participant's feelings, cognitions and behaviours. In the second step, the participant keeps a diary, where he or she records symptoms, complaints, thoughts, worries, related feelings and behaviour. In the third step, the participants are challenged to link their mood to the consequent behaviour, using information from the diary, and then the self‐management approach is introduced in a fourth step. In this phase, the participant explores possibilities to alter his or her behaviour and draws up an action plan. By changing the behaviour that is linked to the depressed mood, mood itself can be altered. In the last step, the progress in achieving the goals of the action plan is evaluated. The intervention is tailor‐made: the number of visits depends upon progress Control: usual care. Regular treatment according to the practice guidelines of the Dutch College of General Practitioners (GP) for type 2 diabetes. These guidelines include regular follow‐up of somatic symptoms but do not involve the detection and treatment of depressive symptoms. Co‐interventions such as pharmacological depression treatments were allowed, and considered non‐differential between groups. Only after the follow‐up, GPs were informed about which participants had participated in the trial |
|
| Outcomes | Outcomes reported in abstract of publication: emotional distress and symptom distress (DSC‐R total score at 9 months P = 0.001; PAID, 9 months P = 0.03); haemoglobin A1c after 9 months | |
| Study details |
Run‐in period: no Trial terminated early: no Trials register identifier: ISRCTN92331982 |
|
| Publication details |
Language of publication: English Non‐commercial funding: Netherlands Organisation for Health Research and Development (ZonMw) programme on Health Care Efficiency Research Publication status: peer‐reviewed journal and full article |
|
| Stated aim for study | Quote from publication: "The aim of this study was to examine whether a nurse‐administered minimal psychological intervention for depressive symptoms improves diabetes‐specific quality of life and glycaemic control in older persons with diabetes." | |
| Notes | Missing values on outcomes during follow‐up were imputed with the last available score of a given outcome | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk |
Quote from publication: "Randomization was then performed ... using a computerized random number generator with a block randomisation scheme stratified by general practice (block size of two)." Comment: probably done |
| Allocation concealment (selection bias) | Low risk |
Quote from publication: "In total ... signed informed consent forms and completed a baseline questionnaire. Randomization was then performed, blinded for the researchers, by an external agency" Comment: probably done |
| Blinding of participants and personnel (performance bias) Adverse events | Low risk |
Quote from publication: "The DSC‐R consists of ... hypoglycaemia ..." Comment: hypoglycaemic event was self‐reported outcome measurement, unclear of other adverse events such as illness or hospital admittance as reported in the study flow chart. Trial author communicated that these data were self‐reported |
| Blinding of participants and personnel (performance bias) All‐cause mortality | Low risk | Comment: no direct quote is available; the study flow chart reported death. Unclear of the method for this outcome measurement. Not defined, but the review authors judge that the outcome measurement is not likely to be influenced by lack of blinding |
| Blinding of participants and personnel (performance bias) Diabetes‐related distress | High risk |
Quote from publication: "Data were collected ... by mailed self‐administered questionnaires." Comment: self‐reported outcome measurement but actual modes of administration unclear, probably self‐administered and similarly done in intervention groups |
| Blinding of participants and personnel (performance bias) HbA1c | Low risk |
Quote from publication: "All general practices were contacted to retrieve participants' haemoglobin A1c (HbA1c) values that were determined between the inclusion phase and the end of the follow‐up" Comment: adjudicated outcome measurement |
| Blinding of participants and personnel (performance bias) Health‐related quality of life | High risk |
Quote from publication: "Data were collected ... by mailed self‐administered questionnaires." Comment: self‐reported outcome measurement but actual modes of administration unclear, probably self‐administered and similarly done in intervention groups |
| Blinding of outcome assessment (detection bias) All‐cause mortality | Low risk | Comment: no direct quote is available, the study flow chart reported death. Unclear of the method for this outcome measurement. Not defined, but the review authors judge that the outcome measurement is not likely to be influenced by lack of blinding |
| Blinding of outcome assessment (detection bias) Adverse events | Low risk |
Quote from publication: "The DSC‐R consists of ... hypoglycaemia ..." Comment: hypoglycaemic event was self‐reported outcome measurement, unclear of other adverse events such as illness or hospital admittance as reported in the study flow chart. Trial author communicated that these data were self‐reported |
| Blinding of outcome assessment (detection bias) Diabetes‐related distress | High risk |
Quote from publication: "Data were collected ... by mailed self‐administered questionnaires." Comment: self‐reported outcome measurement but actual modes of administration unclear, probably self‐administered and similarly done in intervention groups |
| Blinding of outcome assessment (detection bias) HbA1c | Low risk |
Quote from publication: "All general practices were contacted to retrieve participants' haemoglobin A1c (HbA1c) values that were determined between the inclusion phase and the end of the follow‐up" Comment: laboratory outcome measurement |
| Blinding of outcome assessment (detection bias) Health‐related quality of life | High risk |
Quote from publication: "Data were collected ... by mailed self‐administered questionnaires." Comment: self‐reported outcome measurement but actual modes of administration unclear, probably self‐administered and similarly done in intervention groups |
| Incomplete outcome data (attrition bias) Adverse events | Unclear risk |
Quote from publication: "The dropout percentage throughout the follow‐up was comparable between the intervention and control groups (33% vs. 30%, P = 0.62). Dropout was associated only with higher age" Comment: reported and reasons explained, with many unknown reasons as reported in the study flow chart |
| Incomplete outcome data (attrition bias) Diabetes‐related distress | Low risk |
Quote from publication: "The dropout percentage throughout the follow‐up was comparable between the intervention and control groups (33% vs. 30%, P = 0.62). Dropout was associated only with higher age ... Age, gender, educational level, treatment group, baseline value of outcome ... were standard inclusions in the model" Comment: reported and reasons explained |
| Incomplete outcome data (attrition bias) HbA1c | Low risk |
Quote from publication: "The dropout percentage throughout the follow‐up was comparable between the intervention and control groups (33% vs. 30%, P = 0.62). Dropout was associated only with higher age ... Age, gender, educational level, treatment group, baseline value of outcome ... were standard inclusions in the model" Comment: reported and reasons explained |
| Incomplete outcome data (attrition bias) Health‐realted quality of life | Low risk |
Quote from publication: "The dropout percentage throughout the follow‐up was comparable between the intervention and control groups (33% vs. 30%, P = 0.62). Dropout was associated only with higher age ... Age, gender, educational level, treatment group, baseline value of outcome ... were standard inclusions in the model" Comment: reported and reasons explained |
| Selective reporting (reporting bias) | High risk | Comment: HbA1c was mentioned as a covariate in the study design paper (Lamers 2006) but reported as one of the outcome measure in the publication probably due to HbA1c being a significant result, SE was not reported in the publication although was specified as a secondary outcome measure |