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

Abstract

BackgroundDepression 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.MethodsTwo 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.DiscussionWhether 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 registrationClinicalTrials.gov: NCT01714986

The Relationship Between Alexithymia and Type 2 Diabetes: A Systematic Review

“…The excluded publications did not fulfill the inclusion criteria as 23 did not address T2DM, one did not address alexithymia and nine did not address any of the two. Thus, the remaining 11 publications were full text reviewed and four of them were removed for the following reasons: one did not provide English full-text (Shayeghian et al, 2015 ), one did not provide empirical data (Melin et al, 2016 ), and two were more widely addressed to patients with diabetes without providing specific or disaggregated results about patients with T2DM (De Oliveira Regina and Tambascia, 2017 Marchini et al, 2018 ). We concluded that seven papers could be included in our systemic review based on the inclusion criteria.…”

Abdominal obesity in type 1 diabetes associated with gender, cardiovascular risk factors and complications, and difficulties achieving treatment targets: a cross sectional study at a secondary care diabetes clinic

“…Structured nutrition therapy, including reduced energy intake, lower total carbohydrate intake, and carbohydrates with lower glycemic index, has been recommended in combination with aerobic and resistance exercises [ 37 ]. As alexithymia was associated with abdominal obesity [ 25 ], psychoeducation aiming at increased emotional awareness could also be tried [ 28 ].…”

“…This study had a cross sectional design and was one of four baseline analyses [ 25 – 27 ] for a randomized controlled trial ( ClinicalTrials.gov : NCT01714986) where “Affect School with Script Analysis” was tried against “Basic Body Awareness Therapy” for persons with diabetes, inadequate glycemic control and psychological symptoms [ 28 , 29 ]. The participants were outpatients, consecutively recruited by specialist diabetes physicians or diabetes nurses, at regular follow up visits during the period 03/25/2009 to 12/28/2009.…”

Body-Centered Interventions for Psychopathological Conditions: A Review

“…Other Tactile Decrease in mood, stress-induced somatoform disorders, behavioral and personality disorders; schizophrenia; major depression and anorexia nervosa Gyllensten et al, 2003Gyllensten et al, , 2009Hedlund and Gyllensten, 2010;Catalan-Matamoros et al, 2011;Danielsson et al, 2014 Non-movement Acupuncture Other Tactile Reduces tension headaches/migraines, Parkinson's disease symptoms, fibromyalgia, chronic neck and back pain, osteoarthritis pain Middlekauff et al, 2001;Qin et al, 2008;Harris et al, 2009 Functional Relaxation Self Non-tactile Reduces non-specific chest pain, asthma, and tension headaches Loew et al, 2000Loew et al, , 2001Lahmann et al, 2008aLahmann et al, , 2009 Massage Other and Self Tactile Increased weight and growth in pre-term infants, decreased cortisol and dopamine, increased serotonin, increased positive mood, decreased negative emotions, decrease in stress, increase in immunological response, increase in vagal tone Field et al, 2005Field et al, , 2010bField, 2010 Reflexology Other and Self Tactile Decreases anxiety and stress Wang et al, 2008;Miller et al, 2013 Rolfing Other Tactile Decreases anxiety, improved gait in children with spastic cerebral palsy Weinberg and Hunt, 1979;Hansen et al, 2014 types of metrics which assess the effectiveness of BAT: the body awareness scale and the resource oriented body examination which measure body posture, muscle tension, respiration and heart palpitations (Eriksson et al, 2007). BBAT has been effective at reducing physiological conditions such as fibromyalgia, chronic pain, irritable bowel syndrome and non-specific musculoskeletal problems (Gard, 2005;Eriksson et al, 2007) and more recent studies demonstrate potential mood altering effectiveness as well.…”

“…Two studies have investigated the use of BBAT in psychiatric clinics with patients who experienced mood, stressrelated somatoform, behavioral and personality disorders. Both investigations found a significant decrease in symptoms and reduction in overall use and cost of psychiatric services (Gyllensten et al, 2003(Gyllensten et al, , 2009. Thus, the administration of BBAT in psychiatric outpatient clinics seems to be the most promising line of research and more investigation is needed to evaluate its effectiveness within specific subpopulations.…”