Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress 2023 EHA Congress 2023 ASCO Annual Meeting
Clinical Collections
Advances in Alzheimer’s

At a glance: The ONWARDS insulin icodec trials

A round-up of the ONWARDS phase 3 clinical trials evaluating the novel weekly insulin icodec in people with diabetes.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2016

Open Access 01-12-2016 | Study protocol

Affect school and script analysis versus basic body awareness therapy in the treatment of psychological symptoms in patients with diabetes and high HbA1c concentrations: two study protocols for two randomized controlled trials

Authors: Eva O. Melin, Ralph Svensson, Sven-Åke Gustavsson, Agneta Winberg, Ewa Denward-Olah, Mona Landin-Olsson, Hans O. Thulesius

Published in: Trials | Issue 1/2016

Login to get access

Abstract

Background

Depression is linked with alexithymia, anxiety, high HbA1c concentrations, disturbances of cortisol secretion, increased prevalence of diabetes complications and all-cause mortality. The psycho-educational method ‘affect school with script analysis’ and the mind-body therapy ‘basic body awareness treatment’ will be trialled in patients with diabetes, high HbA1c concentrations and psychological symptoms. The primary outcome measure is change in symptoms of depression. Secondary outcome measures are changes in HbA1c concentrations, midnight salivary cortisol concentration, symptoms of alexithymia, anxiety, self-image measures, use of antidepressants, incidence of diabetes complications and mortality.

Methods

Two studies will be performed. Study I is an open-labeled parallel-group study with a two-arm randomized controlled trial design. Patients are randomized to either affect school with script analysis or to basic body awareness treatment. According to power calculations, 64 persons are required in each intervention arm at the last follow-up session. Patients with type 1 or type 2 diabetes were recruited from one hospital diabetes outpatient clinic in 2009. The trial will be completed in 2016. Study II is a multicentre open-labeled parallel-group three-arm randomized controlled trial. Patients will be randomized to affect school with script analysis, to basic body awareness treatment, or to treatment as usual. Power calculations show that 70 persons are required in each arm at the last follow-up session. Patients with type 2 diabetes will be recruited from primary care. This study will start in 2016 and finish in 2023. For both studies, the inclusion criteria are: HbA1c concentration ≥62.5 mmol/mol; depression, alexithymia, anxiety or a negative self-image; age 18–59 years; and diabetes duration ≥1 year. The exclusion criteria are pregnancy, severe comorbidities, cognitive deficiencies or inadequate Swedish. Depression, anxiety, alexithymia and self-image are assessed using self-report instruments. HbA1c concentration, midnight salivary cortisol concentration, blood pressure, serum lipid concentrations and anthropometrics are measured. Data are collected from computerized medical records and the Swedish national diabetes and causes of death registers.

Discussion

Whether the “affect school with script analysis” will reduce psychological symptoms, increase emotional awareness and improve diabetes related factors will be tried, and compared to “basic body awareness treatment” and treatment as usual.

Trial registration

ClinicalTrials.gov: NCT01714986
Literature
1.
Fisher L, Gonzalez JS, Polonsky WH. The confusing tale of depression and distress in patients with diabetes: a call for greater clarity and precision. Diabet Med. 2014;31:764–72.CrossRefPubMedPubMedCentral
2.
Semenkovich K, Brown ME, Svrakic DM, Lustman PJ. Depression in type 2 diabetes mellitus: prevalence, impact, and treatment. Drugs. 2015;75:577–87.CrossRefPubMed
3.
Korczak DJ, Pereira S, Koulajian K, Matejcek A, Giacca A. Type 1 diabetes mellitus and major depressive disorder: evidence for a biological link. Diabetologia. 2011;54:2483–93.CrossRefPubMed
4.
Melin EO, Thunander M, Svensson R, Landin-Olsson M, Thulesius HO. Depression, obesity and smoking were independently associated with inadequate glycemic control in patients with type 1 diabetes. Eur J Endocrinol. 2013;168:861–69.CrossRefPubMed
5.
Melin EO, Thunander M, Landin-Olsson M, Hillman M, Thulesius HO. Depression, smoking, physical inactivity and season independently associated with midnight salivary cortisol in type 1 diabetes. BMC Endocr Disord. 2014;14:75.CrossRefPubMedPubMedCentral
6.
de Groot M, Anderson R, Freedland KE, Clouse RE, Lustman PJ. Association of depression and diabetes complications: a meta-analysis. Psychosom Med. 2001;63:619–30.CrossRefPubMed
7.
Egede LE, Nietert PJ, Zheng D. Depression and all-cause and coronary heart disease mortality among adults with and without diabetes. Diabetes Care. 2005;28:1339–45.CrossRefPubMed
8.
Tomkins SS. Affect, imagery, consciousness: the positive affects, vol. 1. New York: Springer; 1962.
9.
Tomkins SS. Affect, imagery, consciousness. the negative affects, vol. 2. New York: Springer; 1963.
10.
Tomkins SS. Affect, imagery, consciousness: the negative affects: anger and fear. New York: Springer; 1991.
11.
Tomkins SS. Affect, imagery, consciousness. Cognition: duplication and transformation of information, vol. 4. New York: Springer; 1992.
12.
Nathanson DL. Shame and pride, affect, sex, and the birth of the self. London: Norton; 1992.
13.
Nemiah J, Sifnoes P. Affect and fantasy in patients with psychosomatic disorder. In: Ow H, editor. Modern trends in psychosomatic medicine, vol. 2. London: Butterworths; 1970. p. 26–34.
14.
Taylor GJ, Bagby RM. Psychoanalysis and empirical research: the example of alexithymia. J Am Psychoanal Assoc. 2013;61:99–133.CrossRefPubMed
15.
Tolmunen T, Heliste M, Lehto SM, Hintikka J, Honkalampi K, Kauhanen J. Stability of alexithymia in the general population: an 11-year follow-up. Compr Psychiatry. 2011;52:536–41.CrossRefPubMed
16.
Chatzi L, Bitsios P, Solidaki E, Christou I, Kyrlaki E, Sfakianaki M, et al. Type 1 diabetes is associated with alexithymia in nondepressed, non-mentally ill diabetic patients: a case-control study. J Psychosom Res. 2009;67:307–13.CrossRefPubMed
17.
Housiaux M, Luminet O, Van Broeck N, Dorchy H. Alexithymia is associated with glycaemic control of children with type 1 diabetes. Diabetes Metab. 2010;36:455–62.CrossRefPubMed
18.
Zijlstra H, van Middendorp H, Devaere L, Larsen JK, van Ramshorst B, Geenen R. Emotion processing and regulation in women with morbid obesity who apply for bariatric surgery. Psychology & Health. 2012;27:1375–87.CrossRef
19.
Elfhag K, Lundh LG. TAS-20 alexithymia in obesity, and its links to personality. Scand J Psychol. 2007;48:391–98.CrossRefPubMed
20.
21.
Tolmunen T, Lehto SM, Heliste M, Kurl S, Kauhanen J. Alexithymia is associated with increased cardiovascular mortality in middle-aged Finnish men. Psychosom Med. 2010;72:187–91.CrossRefPubMed
22.
Anderson RJ, Grigsby AB, Freedland KE, de Groot M, McGill JB, Clouse RE, et al. Anxiety and poor glycemic control: a meta-analytic review of the literature. Int J Psychiatry Med. 2002;32:235–47.CrossRefPubMed
23.
Björck C, Clinton D, Sohlberg S, Hällström T, Norring C. Interpersonal profiles in eating disorder: ratings of SASB self-image. Psychol Psychother Theory Res Pract. 2010;76:337–49.CrossRef
24.
Jones JM, Lawson ML, Daneman D, Olmsted MP, Rodin G. Eating disorders in adolescent females with and without type 1 diabetes: cross sectional study. BMJ. 2000;320:1563–66.CrossRefPubMedPubMedCentral
25.
Selvin E, Marinopoulos S, Berkenblit G, Rami T, Brancati FL, Powe NR, et al. Meta-analysis: glycosylated hemoglobin and cardiovascular disease in diabetes mellitus. Ann Intern Med. 2004;141:421–31.CrossRefPubMed
26.
Nordwall M, Arnqvist HJ, Bojestig M, Ludvigsson J. Good glycemic control remains crucial in prevention of late diabetic complications – the Linkoping Diabetes Complications Study. Pediatr Diabetes. 2009;10:168–76.CrossRefPubMed
27.
Reynolds RM, Labad J, Strachan MWJ, Braun A, Fowkes FGR, Lee A, et al. Elevated fasting plasma cortisol is associated with ischemic heart disease and its risk factors in people with type 2 diabetes: the Edinburgh type 2 diabetes study. J Clinical Endocrinol Metabol. 2010;95:1602–08.CrossRef
28.
Reynolds RM, Strachan MWJ, Labad J, Lee AJ, Frier BM, Fowkes FG, et al. Morning cortisol levels and cognitive abilities in people with type 2 diabetes: the Edinburgh type 2 diabetes study. Diabetes Care. 2010;33:714–20.CrossRefPubMedPubMedCentral
29.
Bergdahl J. Psychosomatics. Affect based investigation and treatment of patients with psychosomatic problems [In Swedish]. Svensk Rehabilitering. 1999;1:25–7.
30.
Bergdahl J, Larsson A, Nilsson LG, Ahlstrom KR, Nyberg L. Treatment of chronic stress in employees: subjective, cognitive and neural correlates. Scand J Psychol. 2005;46:395–402.CrossRefPubMed
31.
Monsen J, Monsen K. Affects and affect consciousness: a psychotherapy model integrating Silvan Tomkins’s affect- and script theory within the framework of self psychology. In: Goldberg A, editor. Progress in self psychology: pluralism in self psychology. Hillsdale: Analytic Press; 1999. p. 287–306.
32.
Melin EO, Thulesius HO, Persson BA. Affect school for chronic benign pain patients showed improved alexithymia assessments with TAS-20. Biopsychosoc. 2010;4:1–10.CrossRef
33.
Mehling WE, Wrubel J, Daubenmier J, Price CJ, Kerr CE, Silow T, et al. Body Awareness: a phenomenological inquiry into the common ground of mind-body therapies. Philos Ethics Humanit Med. 2011;6:1–6.CrossRef
34.
Gyllensten AL, Ekdahl C, Hansson L. Long-term effectiveness of basic body awareness therapy in psychiatric outpatient care: a randomized controlled study. Adv Physiotherapy. 2009;11:2–12.CrossRef
35.
Malmgren-Olsson E-B, Armelius B-A, Armelius K. A comparative outcome study of body awareness therapy, feldenkrais, and conventional physiotherapy for patients with nonspecific musculoskeletal disorders: changes in psychological symptoms, pain, and self-image. Physiotherapy Theory Practice. 2001;17:77–95.CrossRef
36.
Roxendal G. Body awareness therapy and the body awareness scale, treatment and evaluation in psychiatric physiotherapy, Doctoral thesis. PhD. Sweden: University of Gothenburg; 1985.
37.
Melin E. Psychosomatic aspects on diabetes and chronic pain, alexithymia, depression and salivary cortisol: the affect school and script analysis therapy, Doctoral thesis. PhD. Sweden: Lund University; 2014.
38.
Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983;67:361–70.CrossRefPubMed
39.
Zöger S, Svedlund J, Holgers K-M. The Hospital Anxiety and Depression Scale (HAD) as a screening instrument in tinnitus evaluation. Int J Audiology. 2004;43:458–64.CrossRef
40.
Simonsson-Sarnecki M, Lundh LG, Torestad B, Bagby RM, Taylor GJ, Parker JD. A Swedish translation of the 20-item Toronto Alexithymia Scale: cross-validation of the factor structure. Scand J Psychol. 2000;41:25–30.CrossRefPubMed
41.
Bagby RM, Parker JD, Taylor GJ. The twenty-item Toronto Alexithymia Scale – I. Item selection and cross-validation of the factor structure. J Psychosom Res. 1994;38:23–32.CrossRefPubMed
42.
Bagby RM, Taylor GJ, Parker JD. The twenty-item Toronto Alexithymia Scale – II. Convergent, discriminant, and concurrent validity. J Psychosom Res. 1994;38:33–40.CrossRefPubMed
43.
Halvorsen MS, Monsen JT. Self-image as a moderator of change in psychotherapy. Psychotherapy Res. 2007;17:205–17.CrossRef
44.
Hoelzel W, Weykamp C, Jeppsson JO, Miedema K, Barr JR, Goodall I, et al. IFCC reference system for measurement of hemoglobin A1c in human blood and the national standardization schemes in the United States, Japan, and Sweden: a method-comparison study. Clin Chem. 2004;50:166–74.CrossRefPubMed
45.
Lavalard E, Szymezak J, Leroy N, Gillery P. Evaluation of Variant II analyzer equipped with the new 270-2101 NU kit (Bio-Rad) for HbA 1c assay. Ann Biol Clin. 2009;67:55–65.
46.
Yaneva M, Kirilov G, Zacharieva S. Midnight salivary cortisol, measured by highly sensitive electrochemiluminescence immunoassay, for the diagnosis of Cushing’s syndrome. Cent Eur J Med. 2009;4:59–64.
47.
Vogeser M, Durner J, Seliger E, Auernhammer C. Measurement of late-night salivary cortisol with an automated immunoassay system. Clin Chem Lab Med. 2006;44:1441–45.PubMed
48.
Belaya ZE, Iljin AV, Melnichenko GA, Rozhinskaya LY, Dragunova NV, Dzeranova LK, et al. Diagnostic performance of late-night salivary cortisol measured by automated electrochemiluminescence immunoassay in obese and overweight patients referred to exclude Cushing’s syndrome. Endocrine. 2012;41:494–500.CrossRefPubMed
49.
Deutschbein T, Broecker-Preuss M, Flitsch J, Jaeger A, Althoff R, Walz MK, et al. Salivary cortisol as a diagnostic tool for Cushing’s syndrome and adrenal insufficiency: improved screening by an automatic immunoassay. Eur J Endocrinol. 2012;166:613–18.CrossRefPubMed
50.
Klag MJ, Whelton PK, Randall BL, Neaton JD, Brancati FL, Ford CE, et al. Blood pressure and end-stage renal disease in men. New England J Med. 1996;334:13–8.CrossRef
51.
Williams JMG, Barnhofer T, Crane C, Herman D, Raes F, Watkins E, et al. Autobiographical memory specificity and emotional disorder. Psychological Bulletin. 2007;133:122–48.CrossRefPubMedPubMedCentral
52.
53.
Metadata
Title
Affect school and script analysis versus basic body awareness therapy in the treatment of psychological symptoms in patients with diabetes and high HbA1c concentrations: two study protocols for two randomized controlled trials
Authors
Eva O. Melin
Ralph Svensson
Sven-Åke Gustavsson
Agneta Winberg
Ewa Denward-Olah
Mona Landin-Olsson
Hans O. Thulesius
Publication date
01-12-2016
Publisher
BioMed Central
Published in
Trials / Issue 1/2016
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-016-1347-8

Other articles of this Issue 1/2016

Trials 1/2016 Go to the issue

Study protocol

Comparison of exenatide with biphasic insulin aspart 30 on glucose variability in type 2 diabetes: study protocol for a randomized controlled trial

Study protocol

Effectiveness of a clinical guideline to improve dental health among orthodontically treated patients: study protocol for a cluster randomized controlled trial

Study protocol

A randomized clinical trial to determine the effectiveness of CO-oximetry and anti-smoking brief advice in a cohort of kidney transplant patients who smoke: study protocol for a randomized controlled trial

Study protocol

Prevention of catheter-related bladder discomfort – pudendal nerve block with ropivacaine versus intravenous tramadol: study protocol for a randomized controlled trial

Study protocol

Evaluation of the vascular protective effects of new oral anticoagulants in high-risk patients with atrial fibrillation (PREFER-AF): study protocol for a randomized controlled trial

Study protocol

The influence of a home-based exercise intervention on human health indices in individuals with chronic spinal cord injury (HOMEX-SCI): study protocol for a randomised controlled trial