Evidence map›Paper›PMID 34875666›Full record

Trial reportPsychotherapy and psychosomatics

Evaluation of a Stepped Care Approach to Manage Depression and Diabetes Distress in Patients with Type 1 Diabetes and Type 2 Diabetes: Results of a Randomized Controlled Trial (ECCE HOMO Study).

Andreas Schmitt, Bernhard Kulzer, André Reimer, Christian Herder, Michael Roden, Thomas Haak, Norbert Hermanns

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Psychotherapy and psychosomatics. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01812291 (Efficacy of a Stepped Care Approach to Manage Depression in Diabetic Patients and Putative Inflammatory Mechanisms Between Diabetes and Depression), which is not on this map. Cited by 14 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 1 pooled it
1.9field-weighted citation impact, top 13% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01812291 nacompletednot on this map

Efficacy of a Stepped Care Approach to Manage Depression in Diabetic Patients and Putative Inflammatory Mechanisms Between Diabetes and Depression

TypeinterventionalSponsorForschungsinstitut der Diabetes Akademie MergentheimRan2012 to 2015Enrolled260ConditionsMajor Depressive Disorder, Minor Depressive Disorder, Sub-Threshold Depression, Diabetes MellitusArmsStep 1: Diabetes-Specific CBT (5 group sessions), Step 2: Depression-Specific CBT (6 single sessions), Step 3: Referral to Psychotherapist and/or Psychiatrist, Standard Diabetes Education
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 1 synthesis or guideline pooled it, 16 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. Article
  6. Article
  7. Article
  8. Article
  9. Review
  10. Review
  11. Article
  12. Article
  13. Article
  14. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors at 2 institutions in 1 country.

Andreas SchmittResearch Institute of the Diabetes Academy Mergentheim, Diabetes Center Mergentheim, Bad Mergentheim, Germany.
Bernhard KulzerResearch Institute of the Diabetes Academy Mergentheim, Diabetes Center Mergentheim, Bad Mergentheim, Germany.
André ReimerResearch Institute of the Diabetes Academy Mergentheim, Diabetes Center Mergentheim, Bad Mergentheim, Germany.
Christian HerderGerman Center for Diabetes Research (DZD), Muenchen-Neuherberg, Germany.
Michael RodenGerman Center for Diabetes Research (DZD), Muenchen-Neuherberg, Germany.
Thomas HaakResearch Institute of the Diabetes Academy Mergentheim, Diabetes Center Mergentheim, Bad Mergentheim, Germany.
Norbert HermannsResearch Institute of the Diabetes Academy Mergentheim, Diabetes Center Mergentheim, Bad Mergentheim, Germany.
German Diabetes Center Mergentheim · DEDüsseldorf University Hospital · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionDepression is a common and serious complication of diabetes. Treatment approaches addressing the specific demands of affected patients are scarce.

objectiveThe aim of this work was to test whether a stepped care approach for patients with diabetes and depression and/or diabetes distress yields greater depression reduction than treatment-as-usual.

methodsTwo-hundred and sixty patients with diabetes and elevated depressive symptoms (CES-D ≥16) and/or elevated diabetes distress (PAID ≥40) were randomized to stepped care for depression or diabetes treatment-as-usual. The primary outcome was the rate of meaningful depression reduction at the 12-month follow-up according to the HAMD (score <9 or reduction by ≥50%). Secondary outcomes were changes in depression scores (HAMD/CES-D), diabetes distress (PAID), diabetes acceptance (AADQ), well-being (WHO-5), quality of life (EQ-5D/SF-36), self-care behavior (SDSCA/DSMQ), HbA1c, and biomarkers of inflammation.

resultsOne-hundred and thirty-one individuals were assigned to stepped care and 129 to treatment-as-usual. Overall, 15.4% were lost to follow-up. Meaningful depression reduction was observed in 80.2 versus 51.2% in stepped care versus treatment-as-usual (p < 0.001, intention-to-treat analysis). Of the secondary measures, the HAMD (∆ -3.2, p < 0.001), WHO-5 (∆ 1.5, p = 0.007), and AADQ (∆ -1.0, p = 0.008) displayed significant treatment effects, while effects on CES-D (∆ -2.3, p = 0.065), PAID (∆ -3.5, p = 0.109), and SDSCA (∆ 0.20, p = 0.081) were not significantly different. Both groups showed comparable changes in EQ-5D/SF-36, DSMQ, HbA1c, and biomarkers of inflammation (all p ≥ 0.19).

conclusionsThe stepped care approach improved depression, well-being, and acceptance. The results support that increasing treatment intensity on demand is effective and can help provide more optimal treatment. The inclusion of diabetes-specific interventions may be beneficial for patients with diabetes and elevated depression.

Indexed as

Diabetes Mellitus, Type 1Diabetes Mellitus, Type 2BiomarkersDepressionGlycated HemoglobinHumansInflammationQuality of LifeTreatment OutcomeBiomarkersGlycated HemoglobinCognitive-behavioral therapyDepressive symptomsEmotional distressMood disorderStepped care approach

Identifiers

PMID34875666
OpenAlexW4200443501

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.