Hermanns 2015.
| Methods | Parallel randomised clinical trial; randomisation ratio 1:1 | |
| Participants |
Inclusion criteria: diabetes mellitus; elevated depressive symptoms (CES‐D score ≥ 16); age 18‐70 years; sufficient German
language skills; and written informed consent Exclusion criteria: major depression; current schizophrenia/psychotic disorder, eating disorder, bipolar disorder, addictive disorder, or personality disorder; current use of antidepressant medication or ongoing psychotherapy; being bedridden; and under guardianship Diagnostic criteria: depressive symptoms were assessed using the German version of the CES‐D and the PHQ‐9; diabetes‐related distress was assessed by the German version of the DDS; self‐care activities were measured using the German version of the Summary of Diabetes Self‐Care Activities Measure (SDSCA); psychological well‐being was assessed using the WHO‐5 Well‐Being Index; health‐related quality of life was measured by the EuroQol (EQ‐5D); diabetes acceptance was assessed using the Acceptance and Action Diabetes Questionnaire (AADQ); diabetes treatment satisfaction was assessed by the Diabetes Treatment Satisfaction Questionnaire (DTSQ) |
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| Interventions |
Number of study centres: 1 Treatment before study: — Titration period: no Intervention: the DIAMOS (Diabetes Motivation Strengthening) programme, based on a self‐management/empowerment approach. A key topic of DIAMOS is diabetes‐related distress originating from living with a chronic condition and the distress caused by treatment‐related factors. Another focus is the discrimination between diabetes‐related and unrelated problems and problem‐solving strategies addressing both issues. Another important aim is to prevent relapses in dysfunctional attitudes toward diabetes. A key element of this treatment approach is the exchange between group members about living with diabetes, and the use of master models for successfully coping with the challenges associated with diabetes and its treatment. After the lessons, the participants completed entries in a booklet in which they recorded personally important topics and individual problem solving strategies that emerged from the lesson (e.g. a personal distress model or development of personal coping strategies). At the beginning of each lesson, the entries recorded in this booklet were discussed Control: the participants in the CG participated in a standard group‐based diabetes education programme, including topics such as healthy diet in diabetes, diabetes and exercise, and diabetes and legal issues. |
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| Outcomes | Outcomes reported in abstract of publication: the primary outcome was depressive symptoms. Secondary outcomes were diabetes distress, well‐being, self‐care behaviour, diabetes acceptance, diabetes treatment satisfaction, HbA1c level, and subclinical inflammation | |
| Study details |
Run‐in period: no Trial terminated early: no Trials register identifier: NCT01009138 |
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| Publication details |
Language of publication: English Non‐commercial funding: Competence Network Diabetes Mellitus, which was funded by the Federal Ministry of Education and Research (BMBF) (grant FKZ 01GI0809); the Ministry of Science and Research of the State of North Rhine‐Westphalia; and the German Federal Ministry of Health; supported in part by a grant from the BMBF to the German Center for Diabetes Research (DZD e.V.). Publication status: peer‐reviewed journal and full article |
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| Stated aim for study | Quote from publication: "In a randomised controlled trial, the efficacy of this newly developed program was evaluated after a 12‐month follow‐up period. The primary objective of this study was to test whether DIAMOS was superior in reducing depressive symptoms ... Since DIAMOS also focuses on coping with diabetes‐related distress, the impact of the program on diabetes distress was evaluated as a secondary outcome variable. " | |
| Notes | No mention of missing data handling, probably no imputation of missing values. For the main outcome, an intention‐to‐treat analysis was performed, using the last observation carried forward method. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk |
Quote from publication: "The randomisation occurred externally through the Coordination Centre for Clinical Trials" Comment: probably done |
| Allocation concealment (selection bias) | Low risk |
Quote from publication: "A person independent from the recruitment process randomised the patients to the two treatment groups with a 1:1 allocation" Comment: probably done |
| Blinding of participants and personnel (performance bias) Diabetes‐related distress | High risk |
Quote from publication: "The baseline and 12‐month measurements were performed at the study centre, and the other two measurements were performed by phone and mail ... All measurements were performed in a blinded fashion with respect to group assignment." Comment: self‐reported outcome measurement but involved interview |
| Blinding of participants and personnel (performance bias) HbA1c | Low risk |
Quote from publication: "All measurements were performed in a blinded fashion with respect to group assignment." Comment: adjudicated outcome measurement |
| Blinding of participants and personnel (performance bias) Health‐related quality of life | High risk |
Quote from publication: "The baseline and 12‐month measurements were performed at the study centre, and the other two measurements were performed by phone and mail ... All measurements were performed in a blinded fashion with respect to group assignment." Comment: self‐reported outcome measurement but involve interview |
| Blinding of outcome assessment (detection bias) Diabetes‐related distress | High risk |
Quote from publication: "The baseline and 12‐month measurements were performed at the study centre, and the other two measurements were performed by phone and mail ... All measurements were performed in a blinded fashion with respect to group assignment." Comment: self‐reported outcome measurement but involved interview |
| Blinding of outcome assessment (detection bias) HbA1c | Low risk |
Quote from publication: "All measurements were performed in a blinded fashion with respect to group assignment." Comment: laboratory outcome measurement |
| Blinding of outcome assessment (detection bias) Health‐related quality of life | High risk |
Quote from publication: "The baseline and 12‐month measurements were performed at the study centre, and the other two measurements were performed by phone and mail ... All measurements were performed in a blinded fashion with respect to group assignment." Comment: self‐reported outcome measurement but involved interview |
| Incomplete outcome data (attrition bias) Diabetes‐related distress | High risk |
Quote from publication: "Comparing the randomised and the analysed samples, no significant difference in dropout rates between the DIAMOS group and CG (13.9% vs. 22.7%, P = 0.205) was observed." Comment: dropouts reported but not explained |
| Incomplete outcome data (attrition bias) HbA1c | High risk |
Quote from publication: "Comparing the randomised and the analysed samples, no significant difference in dropout rates between the DIAMOS group and CG (13.9% vs. 22.7%, P = 0.205) was observed. A dropout analysis showed that patients who dropped out of the study were significantly ... younger years of age, P = 0.01) and had a lower BMI ... and poorer glycaemic control" Comment: reported and reasons explained |
| Incomplete outcome data (attrition bias) Health‐realted quality of life | High risk |
Quote from publication: "Comparing the randomised and the analysed samples, no significant difference in dropout rates between the DIAMOS group and CG (13.9% vs. 22.7%, P = 0.205) was observed." Comment: dropouts reported but not explained |
| Selective reporting (reporting bias) | Low risk | Comment: all prespecified outcome measures were reported |