Does treatment of subsyndromal depression improve depression and diabetes related outcomes: protocol for a randomised controlled comparison of psycho-education, physical exercise and treatment as usual.
BACKGROUND
The prevalence of mood difficulties in persons with diabetes is approximately twice that in the general population, affecting the health outcomes and patients' quality of life in an undesirable way. Although subsyndromal depression is an important predictor of a more serious clinical depression, it is often overlooked. This study aims to compare the effects of two non-pharmacological interventions for subsyndromal depression, psychoeducation and physical exercise, with diabetes treatment as usual on mood- and diabetes-related outcomes.


METHODS
Type 2 diabetic patients aged 18-65 yrs. who report mood difficulties and the related need for help in a mail survey will be potential participants. After giving informed consent, they will be randomly assigned to one of the three groups (psychoeducation, physical activity, treatment as usual). Depressive symptoms, diabetes distress, health-related quality of life and diabetes self-care activities will be assessed at baseline, at 6 weeks, 6 months and 12 months. A structured clinical interview for DSM-IV Axis I Disorders (SCID-I) will be performed at baseline and at one-year follow-up in order to determine the clinical significance of the patients' depressive symptoms. Disease-related data will be collected from patients' files and from additional physical examinations and laboratory tests.The two interventions will be comparable in terms of format (small group work), duration (six sessions) and approach (interactive learning; supporting the participants' active roles). The group treated as usual will be informed about their screening results and about the importance of treating depression. They will be provided with brief re-education on diabetes and written self-help instructions to cope with mood difficulties.Primary outcomes will be depressive symptoms. Secondary outcomes will be glycaemic control, diabetes-related distress, self-management of diabetes and health-related quality of life. Tertiary outcomes will be biochemical markers reflecting common pathophysiological processes of insulin resistance, inflammation and oxidative damage that are assumed to be intertwined in both diabetes and depression. The mixed-effect linear model will be used to compare the outcome variables.Power analysis has indicated that the two intervention groups and the control group should comprise 59 patients to enable detection of clinically meaningful differences in depressive symptoms with a power of 80% and alpha = 0.05. Outcomes will be analysed on an intention-to-treat basis.


BACKGROUND
ISRCTN: ISRCTN05673017.
Team for Mental Health, Vuk Vrhovac University Clinic for Diabetes, Endocrinology and Metabolic Diseases, Merkur Teaching Hospital, University of Zagreb, Zagreb, Croatia. pibernik@idb.hr
Mirjana
M
Pibernik-Okanović
Dea
D
Ajduković
Marijana Vučić
MV
Lovrenčić
Norbert
N
Hermanns
D000293:Adolescent; D000328:Adult; D000339:Affect; D000368:Aged; D017523:Croatia; D003863:Depression / Q000175:diagnosis / Q000209:etiology / Q000628:therapy*; D003924:Diabetes Mellitus, Type 2 / Q000175:diagnosis / Q000523:psychology / Q000628:therapy*; D015444:Exercise; D015438:Health Behavior; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D008875:Middle Aged; D010353:Patient Education as Topic; D011569:Psychiatric Status Rating Scales; D011788:Quality of Life; D012107:Research Design; D012648:Self Care; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
Psychosom Med. 2007 Apr;69(3):235-41
17420441
Acta Psychiatr Scand. 2005 Feb;111(2):133-8
15667432
Diabetes Care. 2003 Oct;26(10):2822-8
14514586
Ann Intern Med. 2006 Apr 4;144(7):496-504
16585663
Psychosom Med. 1997 May-Jun;59(3):241-50
9178335
Diabet Med. 2008 Oct;25(10):1133-41
19046190
BMJ. 2005 Oct 15;331(7521):884
16166106
Patient Educ Couns. 2006 Feb;60(2):235-40
16442465
Acta Med Croatica. 2005;59(3):185-9
16095190
Diabetes Care. 2005 Nov;28(11):2668-72
16249537
Arch Intern Med. 2000 Nov 27;160(21):3278-85
11088090
Depress Anxiety. 2000;12(1):30-9
10999243
Diabetes Care. 2000 Jul;23(7):934-42
10895843
Arch Gen Psychiatry. 2004 Oct;61(10):1042-9
15466678
Ann Intern Med. 1998 Oct 15;129(8):613-21
9786808
Diabetes Care. 2001 Jun;24(6):1069-78
11375373
Am J Psychiatry. 2005 Jun;162(6):1171-8
15930066
Neuro Endocrinol Lett. 2008 Jun;29(3):287-91
18580840
Acta Psychiatr Scand. 2004 May;109(5):325-31
15049768
Am J Psychiatry. 1997 Nov;154(11):1593-8
9356570
Psychosom Med. 2001 Jul-Aug;63(4):619-30
11485116
Diabetes Care. 2000 May;23(5):618-23
10834419
Diabetes Care. 2004 Sep;27(9):2154-60
15333477
Ann Fam Med. 2006 Jan-Feb;4(1):46-53
16449396
Acta Diabetol. 2003 Jun;40(2):95-100
12861408
BMJ. 2001 Mar 31;322(7289):763-7
11282860
Trials. 2009 Aug 26;10:78
19709404
Diabetes Care. 2004 May;27(5):1066-70
15111522
Ann Intern Med. 2004 Jun 15;140(12):1015-24
15197019
Diabetes Care. 2004 Mar;27(3):813-23
14988310
J Gen Intern Med. 2004 Dec;19(12):1192-9
15610329
BMC Fam Pract. 2003 May 14;4:7
12747810
Diabetes Care. 1998 Dec;21(12):2191-2
9839117
Arch Gen Psychiatry. 2006 May;63(5):521-9
16651509
Gen Hosp Psychiatry. 2006 May-Jun;28(3):205-12
16675363
Diabetologia. 2005 Jun;48(6):1038-50
15864529