Research ers noted small improvements in body mass index immediately after the intervention was provided and at six months , along with improved weight post intervention .
Diabetes knowledge and self efficacy improved immediately following receipt of the intervention , and knowledge also at six months .
The intervention did not improve blood pressure .
Evidence is insufficient to show whether type 2 diabetes self management interventions for people with severe mental illness are effective in improving outcomes .
BACKGROUND People with severe mental illness are twice as likely to develop type 2 diabetes as those without severe mental illness .
Treatment guidelines for type 2 diabetes recommend that structured education should be integrated into routine care and should be offered to all .
However , for people with severe mental illness , physical health may be a low priority , and motivation to change may be limited .
These additional challenges mean that the findings reported in previous systematic review s of diabetes self management interventions may not be generalised to those with severe mental illness , and that tailored approaches to effective diabetes education may be required for this population .
OBJECTIVES To assess the effects of diabetes self management interventions specifically tailored for people with type 2 diabetes and severe mental illness .
Study protocol of the Diabetes and Depression Study (DAD): a multi-center randomized controlled trial to compare the efficacy of a diabetes-specific cognitive behavioral group therapy versus sertraline in patients with major depression and poorly controlled diabetes mellitus
Background Depression is common in diabetes and associated with hyperglycemia , diabetes related complications and mortality . No single intervention has been identified that consistently leads to simultaneous improvement of depression and glycemic control . Our aim is to analyze the efficacy of a diabetes-specific cognitive behavioral group therapy ( CBT ) compared to sertraline ( SER ) in adults with depression and poorly controlled diabetes . Methods / Design This study is a multi-center parallel arm r and omized controlled trial currently in its data analysis phase . We included 251 patients in 70 secondary care centers across Germany . Key inclusion criteria were : type 1 or 2 diabetes , major depression ( diagnosed with the Structured Clinical Interview for DSM-IV , SCID ) and hemoglobin A1C > 7.5 % despite current insulin therapy . During the initial phase , patients received either 50–200 mg/d sertraline or 10 CBT sessions aim ing at the remission of depression and enhanced adherence to diabetes treatment and coping with diabetes . Both groups received diabetes treatment as usual . After 12 weeks of this initial open-label therapy , only the treatment-responders ( 50 % depression symptoms reduction , Hamilton Depression Rating Scale , 17-item version [ HAMD ] ) were included in the subsequent one year study phase and represented the primary analysis population . CBT-responders received no further treatment , while SER-responders obtained a continuous , flexible-dose SER regimen as relapse prevention . Adherence to treatment was analyzed using therapeutic drug monitoring ( measurement of sertraline and N-desmethylsertraline concentrations in blood serum ) and by counting the numbers of CBT sessions received . Outcome assessment s were conducted by trained psychologists blinded to group assignment . Group differences in HbA1c ( primary outcome ) and depression ( HAMD , secondary outcome ) between 1-year follow-up and baseline will be analyzed by ANCOVA controlling for baseline values . As primary hypothesis we expect that CBT leads to significantly greater improvement of glycemic control in the one year follow-up in treatment responders of the short term phase . Discussion The DAD study is the first r and omized controlled trial comparing antidepressants to a psychological treatment in diabetes patients with depression . The study is investigator initiated and was supported by the ‘ Förderprogramm Klinische Studien ( Clinical Trials ) ’ and the ‘ Competence Network for Diabetes mellitus ’ funded by the Federal Ministry of Education and Research ( FKZ 01KG0505).Trial registration Current controlled trials IS RCT N89333241
Research ers noted small improvements in body mass index immediately after the intervention was provided and at six months , along with improved weight post intervention .
Diabetes knowledge and self efficacy improved immediately following receipt of the intervention , and knowledge also at six months .
The intervention did not improve blood pressure .
Evidence is insufficient to show whether type 2 diabetes self management interventions for people with severe mental illness are effective in improving outcomes .
BACKGROUND People with severe mental illness are twice as likely to develop type 2 diabetes as those without severe mental illness .
Treatment guidelines for type 2 diabetes recommend that structured education should be integrated into routine care and should be offered to all .
However , for people with severe mental illness , physical health may be a low priority , and motivation to change may be limited .
These additional challenges mean that the findings reported in previous systematic review s of diabetes self management interventions may not be generalised to those with severe mental illness , and that tailored approaches to effective diabetes education may be required for this population .
OBJECTIVES To assess the effects of diabetes self management interventions specifically tailored for people with type 2 diabetes and severe mental illness .