Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2016 Apr 27;17(1):221.
doi: 10.1186/s13063-016-1347-8.

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

Eva O Melin  1   2   3 , Ralph Svensson  4 , Sven-Åke Gustavsson  5 , Agneta Winberg  6 , Ewa Denward-Olah  6 , Mona Landin-Olsson  7   8 , Hans O Thulesius  9   6   10
Affiliations
Randomized Controlled Trial

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

Eva O Melin et al. Trials. .

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.

Keywords: Alexithymia; Anxiety; Cortisol; Depression; Diabetes mellitus; HbA1c; Mind-body therapy; Psycho-education; Randomized controlled trial.

PubMed Disclaimer

Figures

Fig. 1
Fig. 1
Description of criteria for randomization and allocation to ASSA (Studies I and II), BBAT (Studies I and II) and treatment as usual (Study II)
Fig. 2
Fig. 2
Study flow chart for Study I
Fig. 3
Fig. 3
Study flow chart for Study II
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

See all "Cited by" articles

References

    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. doi: 10.1111/dme.12428. - DOI - PMC - PubMed
    1. Semenkovich K, Brown ME, Svrakic DM, Lustman PJ. Depression in type 2 diabetes mellitus: prevalence, impact, and treatment. Drugs. 2015;75:577–87. doi: 10.1007/s40265-015-0347-4. - DOI - PubMed
    1. 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. doi: 10.1007/s00125-011-2240-3. - DOI - PubMed
    1. 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. doi: 10.1530/EJE-13-0137. - DOI - PubMed
    1. 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. doi: 10.1186/1472-6823-14-75. - DOI - PMC - PubMed

Publication types

MeSH terms

Associated data